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D010003: Osteoarthritis

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (15)


Name (Synonyms) Correlation
drug1477 Electrotherapy group Wiki 0.41
drug4033 Software Messaging Wiki 0.41
drug2948 On-site exercise and education Wiki 0.41
Name (Synonyms) Correlation
drug1694 Flywheel exercise Wiki 0.41
drug3257 Placebo matching to GSK3858279 (SC or IV) Wiki 0.41
drug1564 Exercise and Cognitive Training Wiki 0.41
drug1563 Exercise Training Only Wiki 0.41
drug1756 GSK3858279 IV Wiki 0.41
drug1757 GSK3858279 SC Wiki 0.41
drug2947 On-line exercise and education Wiki 0.41
drug1397 Dynamic 3D bone motion capture Wiki 0.41
drug5303 wedged insole Wiki 0.41
drug3258 Placebo matching to GSK3858279 (SC) Wiki 0.41
drug1917 Home exercise Wiki 0.29
drug1293 Dexamethasone Wiki 0.12

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D020370 Osteoarthritis, Knee NIH 0.55
D015207 Osteoarthritis, Hip NIH 0.41
D005356 Fibromyalgia NIH 0.18
Name (Synonyms) Correlation
D051346 Mobility Limitation NIH 0.18
D059350 Chronic Pain NIH 0.11
D008173 Lung Diseases, Obstructive NIH 0.10
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.09
D006973 Hypertension NIH 0.08
D013315 Stress, Psychological NIH 0.07

Correlated HPO Terms (8)


Name (Synonyms) Correlation
HP:0002758 Osteoarthritis HPO 1.00
HP:0005086 Knee osteoarthritis HPO 0.55
HP:0008843 Hip osteoarthritis HPO 0.41
Name (Synonyms) Correlation
HP:0002355 Difficulty walking HPO 0.18
HP:0012532 Chronic pain HPO 0.11
HP:0006536 Pulmonary obstruction HPO 0.10
HP:0006510 Chronic pulmonary obstruction HPO 0.09
HP:0000822 Hypertension HPO 0.08

Clinical Trials

Navigate: Correlations   HPO

There are 6 clinical trials


1 Improving the Detection, Classification and Treatment of Misaligned Arthritic Ankles

The Veteran population is prone to foot and ankle maladies from common injuries such as sprains, and diseases such as ankle osteoarthritis (cartilage damage). More specific to Veterans are prior service injuries of the foot and ankle, which historically account for nearly a quarter of injuries received. These injuries include bone fractures and ligament damage. Some of these injuries may lead to poor ankle joint alignment, which over time could lead to osteoarthritis due to abnormal wear on a day to day basis. The goal of this proposal is to use a novel technology - biplane fluoroscopy, to study the movement of ankles which are misaligned in subjects with ankle osteoarthritis. This proposal will also benefit current diagnostic methods with additional information. Last, this proposal will test the effectiveness of a conservative treatment (modified shoe insoles) to correct or reduce the misalignment in ankles. This proposal will create evidence about: the nature of ankle osteoarthritis, the accuracy of diagnosing alignment, and conservative treatment for patients with ankle OA.

NCT03440008
Conditions
  1. Ankle Osteoarthritis
Interventions
  1. Other: Dynamic 3D bone motion capture
  2. Device: wedged insole
MeSH:Osteoarthritis
HPO:Osteoarthritis

Primary Outcomes

Description: The 3D movement between the tibia and talus bones will be assessed using biplane fluoroscopy, for OA and control subjects during shod gait.

Measure: Tibio-talar kinematics during gait

Time: 4 hour session

Description: The sensitivity to correctly diagnose dynamic misalignment by using static x-ray images, will be determined for the OA population.

Measure: Static ankle alignment sensitivity

Time: 4 hour session

Description: The effect that wedged insoles have on varus / valgus misalignment will be assessed using dynamic 3D x-ray

Measure: Decrease in misalignment during gait using wedged insoles

Time: 4 hour session
2 A Two-part Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Intravenous and Subcutaneous Doses of GSK3858279 in Healthy Participants and to Evaluate the Efficacy of Repeat Subcutaneous Doses in Participants With Osteoarthritis of the Knee

This study is the first administration of GSK3858279 in humans and will be conducted in two parts: Part A will consist of a single ascending dose escalation design to evaluate safety, tolerability, PK, TE and immunogenicity of either a single intravenous (IV) or a single subcutaneous (SC) dose. Approximately 48 healthy participants will be enrolled in 6 cohorts and randomized to 3:1 ratio (GSK3858279 or placebo). Part B will evaluate safety, tolerability, efficacy (pain), PK, TE and immunogenicity after repeat SC dosing. Approximately 50 OA participants will be randomized in a parallel group design to receive either GSK3858279 or placebo in a 1:1 ratio.

NCT03485365
Conditions
  1. Pain, Inflammatory
Interventions
  1. Drug: GSK3858279 IV
  2. Drug: GSK3858279 SC
  3. Drug: Placebo matching to GSK3858279 (SC or IV)
  4. Drug: Placebo matching to GSK3858279 (SC)
MeSH:Osteoarthritis
HPO:Osteoarthritis

Primary Outcomes

Description: AEs and SAEs will be collected.

Measure: Part A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Time: Up to 141 days

Description: Number of participants with abnormal hematology, chemistry, urinalysis parameters, ECG findings, and vital signs will be analyzed.

Measure: Part A and B: Number of participants with abnormal hematology, chemistry, urinalysis parameters, electrocardiogram (ECG) findings, and vital signs

Time: Up to 141 days

Description: Change from Baseline in knee pain due to OA will be assessed by average of daily pain NRS at Week 8. The pain NRS is an 11-point scale (0-10) for self-reporting of average knee pain where 0 indicates no pain, and 10 represents the worst possible pain.

Measure: Part B: Change from Baseline in knee pain as assessed by average of daily pain numeric rating scale (NRS) at Week 8

Time: Baseline and Week 8

Description: Change from Baseline in worst knee pain intensity will be assessed using NRS at Week 8. The pain NRS is an 11-point scale (0-10) for self-reporting of average knee pain where 0 indicates no pain, and 10 represents the worst possible pain.

Measure: Part B: Change from Baseline in worst knee pain intensity as assessed by NRS at Week 8

Time: Baseline and Week 8

Secondary Outcomes

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Serum concentrations of GSK3858279 following a single IV dose

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Serum concentration of GSK3858279 following single SC dose

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: Serum concentration of GSK3858279 following repeat SC dose

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) following a single IV dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: AUC from zero to time t (0-t) (AUC[0-t]) following a single IV dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: AUC from zero to infinity (0-infinity) (AUC[0-infinity]) following a single IV dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: AUC(0-tau) following a single SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: AUC(0-t) following a single SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: AUC(0-infinity) following a single SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: AUC(0-tau) following a repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: AUC(0-t) following a repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: AUC(0-infinity) following a repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Maximum concentration (Cmax) after a single IV dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Cmax after single SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: Cmax after repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Half-life (t1/2) following a single IV dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: t1/2 following a single SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: t1/2 following a repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Clearance (CL) following a single IV dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: CL following a single SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: CL following a repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Volume of distribution at steady state (Vss) following a single IV dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Vss following a single SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: Vss following a repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points

Measure: Part A: Volume of distribution (V) following a single IV dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part A: Volume of distribution (V) following a single SC dose of GSK3858279

Time: Up to 141 days

Description: Blood samples for PK analysis of GSK3858279 will be collected at the indicated time points.

Measure: Part B: Volume of distribution (V) following a repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Serum samples will be collected for evaluation of free concentrations of CCL17 at indicated time points.

Measure: Part A: Free Chemokine ligand 17 (CCL17) levels in serum following single IV dose of GSK3858279

Time: Up to 141 days

Description: Serum samples will be collected for evaluation of free concentrations of CCL17 at indicated time points.

Measure: Part A: Free CCL17 levels in serum following single SC dose of GSK3858279

Time: Up to 141 days

Description: Serum samples will be collected for evaluation of free concentrations of CCL17 at indicated time points.

Measure: Part B: Free CCL17 levels in serum following repeat SC dose of GSK3858279

Time: Up to 141 days

Description: Serum samples will be collected for evaluation of total concentrations of CCL17 at indicated time points.

Measure: Part A: Total CCL17 levels in serum following single IV dose of GSK3858279

Time: Up to 141 days

Description: Serum samples will be collected for evaluation of total concentrations of CCL17 at indicated time points.

Measure: Part A: Total CCL17 levels in serum following single SC dose of GSK3858279

Time: Up to 141 days

Description: Serum samples will be collected for evaluation of total concentrations of CCL17 at indicated time points.

Measure: Part B: Total CCL17 levels in serum following repeat SC dose of GSK3858279

Time: Up to 141 days
3 Acceptance and Commitment Therapy Delivered by Automated Software Messaging

This study aims to 1) observe the course of pain, 2) mental status, and 3) possible effect of a behavioral intervention delivered via an automated mobile phone messaging robot in patients were indicated and/or scheduled to undergo joint replacement but have been cancelled or delayed due to the COVID-19 crisis.

NCT04329897
Conditions
  1. Hip Osteoarthritis
  2. Knee Osteoarthritis
  3. Mental Stress
  4. Coronavirus
Interventions
  1. Behavioral: Software Messaging
MeSH:Osteoarthritis Osteoarthritis, Knee Osteoarthritis, Hip Stress, Psychological
HPO:Hip osteoarthritis Knee osteoarthritis Osteoarthritis

Primary Outcomes

Description: PROMIS Pain Intensity 3A short form is a 3 question survey measuring an individual's pain over the past 7 days. It utilizes a scale of 1 (no pain) to 5 (very severe pain) for all questions. The scores for the 3 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 30.7 to 71.8 for the PROMIS Pain Intensity 3A instrument. Higher t-score values represent worse pain outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Measure: Change in reported pain intensity score (PROMIS Pain Intensity 3A) Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 3A short form scores collected from all participating subjects.

Time: Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.

Description: PROMIS Pain Intensity 1A short form is a 1 question survey measuring an individual's average pain over the past 7 days. It utilizes a scale of 0 (no pain) to 10 (worst imaginable pain). Higher values represent worse pain outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Measure: Change in reported pain intensity score (PROMIS Pain Intensity 1A) Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 1A short form scores collected from all participating subjects.

Time: Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.

Description: The PROMIS Pain Interference 8A short form is an 8 question survey that measures how much pain has interfered in the respondent's life over the past 7 days. It utilizes a scale of 1 (not at all) to 5 (very much) for all questions. The scores for all 8 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 40.7 to 77.0 for the PROMIS Pain Interference 8A instrument. Higher t-score values represent worse pain interference outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Measure: Change in reported pain interference score Patient-reported outcomes measurement information system (PROMIS) Pain Interference 8A short form scores collected from all participating subjects.

Time: Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.

Description: The PROMIS Emotional Distress-Anxiety 8A short form is an 8 statement survey that measures how much emotional distress, specifically due to anxiety, a respondent has experienced over the past 7 days. It utilizes a scale of 1 (never) to 5 (always) for all the statements. The scores for all 8 statements are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 37.1 to 83.1 for the PROMIS Emotional Distress-Anxiety 8A instrument. Higher t-score values represent worse anxiety caused emotional distress outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Measure: Change in reported emotional distress (anxiety) score. Patient-reported outcomes measurement information system (PROMIS) Emotional Distress-Anxiety 8A short form scores collected from all participating subjects.

Time: Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.
4 On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many on-site health care services are unavailable. This study seeks to investigate the relative effectiveness of an alternative on-line delivery model of exercise and education compared to on-site delivery in patients with knee osteoarthritis.

NCT04437134
Conditions
  1. Knee Osteoarthritis
Interventions
  1. Other: On-line exercise and education
  2. Other: On-site exercise and education
MeSH:Osteoarthritis Osteoarthritis, Knee
HPO:Knee osteoarthritis Osteoarthritis

Primary Outcomes

Description: Summary score from the Knee injury and Osteoarthritis Outcome Score, short version (KOOS 12). The summary score is calculated as the average score from the KOOS 12 subscales pain, function and quality of life (QOL), ranging from 0 (worst) to 100 (best).

Measure: Knee impact summary

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Secondary Outcomes

Description: Fast-paced walking ability is recorded by the physiotherapists and evaluated using the 40-m fast-paced walk test.

Measure: Fast-paced walking ability

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)

Description: Chair-stand ability is recorded by the physiotherapists and evaluated using the 30-s chair-stand test.

Measure: Chair-stand ability

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)

Description: Patients self-report of function during daily life using the subscale function from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).

Measure: Self-reported function

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-report of pain using the subscale pain from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).

Measure: Self-reported pain

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-report of quality of life using the subscale quality of life from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).

Measure: Self-reported quality of life

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Mean pain intensity during the last week in the most affected knee is evaluated on a 100 mm visual analogue scale (VAS) with terminal descriptors of 'no pain' (0 mm) and 'maximum pain' (100 mm).

Measure: Pain intensity

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-report of time spent (frequency and duration) on structured physical activity and exercise.

Measure: Physical activity and exercise

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Other Outcomes

Description: Patients self-report of satisfaction with the GLA:D program.

Measure: Patient satisfaction

Time: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-reporting if, how and where they have continued exercising.

Measure: Continuation of exercise

Time: Follow-up point: 12 months

Description: Patients self-report their current activity levels using the University of California, Los Angeles (UCLA) activity scale, ranging from 1 (inactive, dependent on others) to 10 (regular participation in high-impact sports).

Measure: Self-reported activity levels

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-report of use of acquired skills and knowledge from the GLA:D program.

Measure: Usage of what was learned during GLA:D

Time: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-report of how they handle flare-ups in their knee OA symptoms.

Measure: Symptom management

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Intake of painkillers is evaluated by the physiotherapist asking the patients about intake of any joint related medication. If taking painkillers, the patients are asked which type and whether or not they were taken because of their knee pain.

Measure: Intake of pain killers

Time: Primary follow-up: Change from baseline to completion of GLA:D program (an average of three months).

Description: Patients self-report of sick leave due to knee symptoms.

Measure: Sick leave

Time: Follow-up points: Baseline and 12 months

Description: Patients self-report of their health situation using EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) score (-0.624 to 1; worst to best).

Measure: Health-related quality of life, index score

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-report of their health situation using the EuroQol visual analogue scale (EQ VAS), ranging from 0-100 (worst to best).

Measure: Health-related quality of life, visual analogue scale

Time: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-report of current knee condition compared to before participation in GLA:D, scored on a 7-point likert scale (much worse to much better).

Measure: Global perceived effect

Time: Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months

Description: Patients self-report of pain during each exercise session, rated using a numeric pain rating scale (NPRS) 0-10, with zero representing no pain and 10 representing extreme pain.

Measure: Pain during exercise (only for on-line group)

Time: Immediately prior to, and immediately after each exercise session
5 Combined Cognitive and Exercise Training for Older Adults: Feasibility & Effectiveness

The overarching aim of this project is to implement and evaluate a proven cognitive training regimen in combination with a community exercise program among older adults who attend wellness exercise programs at the YMCA. To support this aim, the investigators have developed a collaboration with the YMCA of Kitchener-Waterloo, which offer exercise programs targeted to older adults. The specific objectives are: (1) to evaluate the feasibility of a combined exercise and cognitive training in a community-setting among older adults; and (2) to conduct a preliminary evaluation and comparison of changes in cognitive function, physical function, well-being and self-efficacy with 12-weeks of combined exercise and cognitive training versus exercise alone. The hypothesis for each objective are as follows: (1) It is anticipated that this program will be feasible to implement and will be well accepted by the participants and exercise providers. (2) The investigators may not have the power to find statistically significant differences between the control and experimental groups for physical and cognitive function. However, the investigators expect to observe positive changes between the pre- and post-assessments, suggesting improved cognitive function and mobility as a result of the 12-week program.

NCT04515758
Conditions
  1. Osteo Arthritis
  2. Osteoporosis
  3. Joint Replacement
  4. Fibromyalgia
  5. High Blood Pressure
  6. Stable Heart Conditions
  7. Chronic Obstructive Pulmonary Disease
  8. Diabetes
  9. Obesity
Interventions
  1. Other: Exercise and Cognitive Training
  2. Other: Exercise Training Only
MeSH:Osteoporosis Fibromyalgia Osteoarthritis Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Hypertension
HPO:Chronic pulmonary obstruction Hypertension Osteoarthritis Pulmonary obstruction

Primary Outcomes

Description: Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)

Measure: Recruitment Rate

Time: Pre-program (baseline)

Description: Percentage of people who completed the full program and all assessments

Measure: Completion Rate

Time: Through study completion, 12 weeks

Description: Percentage of people who attended program sessions (exercise and cognitive training components)

Measure: Attendance

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

Description: Participant and instructors rating of program components and overall program (via hand-written questionnaire). Participants and instructors must rate their level of agreement (1 = strongly disagree, 2 = disagree, 3 = no opinion, 4 = agree, 5 = strongly agree) with various statements. The higher the rating, the greater the satisfaction. They also must rate if the difficulty of the program was optimal, somewhat easy or hard, or too easy or hard. They must also specify how much money they would be willing to spend on the program. They are also given an opportunity to record optional additional comments/recommendation.

Measure: Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program

Time: Mid-point (6 weeks) and post-program (12 weeks)

Description: Financial cost of running program (equipment purchased for study - cognitive training tablet and stands - and YMCA staff pay) as reported by researcher and YMCA staff

Measure: Cost of program

Time: Post-program (12 weeks)

Description: Self-reported biological sex (at birth) using basic demographics questionnaire

Measure: Sex

Time: Pre-program (baseline)

Description: One-on-one interview with researcher, answering broad questions about their experience in the program and study

Measure: Participant and Instructor perceived program experience and satisfaction

Time: Post-program (at 12 weeks)

Description: Experience of participants and instructors will also be observed by the researcher (observational notes will be taken by the researcher during each class). No names of participants and instructors will be recorded.

Measure: Participant and Instructor observer-perceived program experience and satisfaction

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

Description: Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire

Measure: Education

Time: Pre-program (baseline)

Description: Self-reported previous and current occupations using basic demographics questionnaire

Measure: Occupation

Time: Pre-program (baseline)

Description: Self-reported previous and current medical conditions using basic demographics questionnaire

Measure: Medical Condition

Time: Pre-program (baseline)

Description: Self-reported previous and current medications using basic demographics questionnaire

Measure: Medications

Time: Pre-program (baseline)

Description: Using the Montreal Cognitive Assessments (brief clinical tool) to assess visual/spatial abilities, working memory, executive functioning, language, abstraction, and orientation). Will be used to describe participants' baseline cognitive status (a score out of 30 is measured).

Measure: Montreal Cognitive Assessment (global cognitive function)

Time: Pre-program (baseline)

Description: Using the International Physical Activities Questionnaire (IPAQ) to assess physical activity level based on self-reported frequency and duration of job-related, house work-related, transportation-related, and leisure-related physical activities done in the past week. METS-minutes/week will be calculated and reported (i.e. take the number of minutes doing an activity in the past week and multiply by the appropriate metabolic equivalent, which will vary based on the intensity of the physical activity).

Measure: Physical Activity Level

Time: Pre-program (baseline)

Description: Using a cognitive activity scale (score of 0-4 per activity) that requires participants to self-report how often they typically engage in a variety of mentally stimulating activities (i.e. playing card games, reading, cooking, etc.) The more frequently they engage in the activity, the higher the score.

Measure: Participant cognitive activity

Time: Pre-program (baseline)

Description: Using a scale (score of 0-3 per group) that requires participants to self-report how often they typically interact (face-to-face or virtually) with different groups of people (i.e. their spouse, family, friends, co-workers, etc.). The more frequently they interact with the group, the higher the score.

Measure: Participant social activity

Time: Pre-program (baseline)

Description: Self-reported years of age using basic demographics questionnaire

Measure: Participant and Instructor Age

Time: Pre-program (baseline)

Secondary Outcomes

Description: STROOP task which assesses the length of time (seconds) it takes for a participant to correctly name a coloured square (test 1), read the name of a colour (test 2), and say the name of the colour that a word is printed in (test 3). Number of corrected and uncorrected errors are also recorded.

Measure: Change in Stroop Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Trails Making Test Part A and B. Part A assesses visual search (participants must connect numbered circles in ascending numerical order (1-2-3-etc). Part B assesses working memory and task-switching (participants must connect circles in ascending numerical and alphabetical order (1-A-2-B- etc.). Time to complete the tests (second) and errors (number) made during the tests are recorded.

Measure: Change in Trail Making Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Resting (seated) heart rate (beats per minute) using an automatic blood pressure cuff

Measure: Change in Resting Heart Rate

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Resting (seated) blood pressure (millimeters of mercury) using an automatic blood pressure cuff

Measure: Change in Resting Systolic and Diastolic Blood Pressure

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Using hand dynamometer (assessing grip strength in lbs) for right and left hand (two trials per hand)

Measure: Change in Grip Strength

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Weight (using automatic scale to measure in lbs, converted to kg) and height (measured in feet and inches, converted to meters) measured and combined to provide BMI (kg/m^2)

Measure: Change in Body Mass Index (BMI)

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Divide waist circumference (cm) by hip circumference (cm) to get ratio calculation

Measure: Change in Hip-to-Waist Circumference Ratio

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Agility and functional balance will be assessed using the Timed Up-and-Go (participants stand up from a chair, walk 6 meters, turn around an object, walk back to chair, and sit down). Time to complete test is measured (seconds) and assessor's observational notes of performance are taken.

Measure: Change in Timed Up-and-Go Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Agility and functional balance will be assessed using the Four Square Step Test (participants must step over lines that are set up in a cross formation, creating 4 quadrants. They must step forward, backward, and side to side in a specific pattern (i.e. from quadrant 1 to quadrant 2, to quadrant 3, to quadrant 4). Time to complete test is recorded in seconds.

Measure: Change in Four Square Step Test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Lower body strength will be assessed using the 5 Time Sit-to-Stand (participants must complete 5 sit-to-stands from a chair as fast as they can). Time to complete all 5 is recorded in seconds.

Measure: Change in Sit-to-Stand Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Functional fitness will be assessed using the 6 minute walk (participants walk along indoor track for 6 minutes). The number of laps achieved in 6 minutes is recorded. Assessor's observational notes of walking performance is also recorded.

Measure: Change in 6-minute walk test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Well-being will be self-reported using the "Vitality-Plus Scale" (self-reported general health questionnaire - rating of sleep quality, appetite, general energy level, etc.). Participants rate their degree of health on a scale from 1 - 5 (the higher the rating, the better their perceived overall well-being).

Measure: Change in Overall Well-being

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Bandura Scale (named after the researcher who developed it) - self-reported rating of confidence (0 - 100%) to continue exercising routinely in various hypothetical situations (i.e. if one is sick, if the weather is poor, etc). The greater the confidence, the higher the score

Measure: Change in Exercise-related Self-Efficacy

Time: Pre-program (baseline) and post-program (12 weeks)
6 Investigation of the Effectiveness of a Structured Squat-based Program in Knee Osteoarthritis Rehabilitation

The main purpose of the study is to examine the effect of squat-based exercise approach in individuals with knee osteoarthritis. The aim of this study is to compare effect to three groups (flywheel exercise group, electrotherapy modality group and home exercise group) and also decrease the pain, increase muscle strength, activation values and increase the functional level of individuals. Osteoarthritis is the most common rheumatological disease in the world that primarily results in progressive cartilage destruction. Changes occurring as a result of osteoarthritis are the main cause of disability and are most common in the knee joint. Osteoarthritis; problems such as pain, tenderness, joint stiffness, joint swelling, movement restriction, joint deformities, loss of muscle strength, decreased functional capacity and impaired quality of life are observed. The daily life activities of individuals with knee osteoarthritis are restricted by the problems of walking up and down stairs, getting out of the chair, standing, squatting, walking. Improving the symptoms of the disease is an important goal of the rehabilitation process of patients with knee osteoarthritis. In individuals with knee osteoarthritis, joint structure and deformation in cartilage also show loss of strength with muscles. Strengthening exercises have been used in patients with knee osteoarthritis for a long time. Squat exercise is a type of exercise that is widely used as a strengthening exercise.

NCT04588558
Conditions
  1. Osteoarthritis Knees Both
  2. Pain, Chronic
  3. Walking, Difficulty
Interventions
  1. Device: Flywheel exercise
  2. Other: Home exercise
  3. Device: Electrotherapy group
MeSH:Osteoarthritis Osteoarthritis, Knee Chronic Pain Mobility Limitation
HPO:Chronic pain Difficulty walking Knee osteoarthritis Osteoarthritis

Primary Outcomes

Description: The primary outcome measures included the level of function determined by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) . WOMAC is a specific, valid, reliable criterion for knee osteoarthritis and includes 24 questions under three subheadings: pain, stiffness and physical function. Each question was scored according to the Likert scale as 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

Measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time: 10 minutes

Secondary Outcomes

Description: EMG-BF (Intelect Advanced Color Combo + EMG, Chattanooga Group, TN, USA) was used to evaluate muscle activation level. The screen scale was used as a visual feedback, as an increased or decreasing signal tone with varying muscle activity as sensory feedback. The undermentioned muscles will be evaluated in study, Rectus femoris Vastus lateralis Vastus medialis Biceps femoris Gastrocnemius

Measure: EMG-BF

Time: 10 minutes

Description: A dynamometer was used to evaluate muscle strength. Muscle strength was evaluated in the following muscles, each measurement was made three times and the average was taken. M. Iliopsoas M. Gluteus Maximus M. Gluteus Medius M. Quadriceps Femoris Hamstring muscle group M. Gastrosoleus M. Tibialis Anterior

Measure: Muscle strength

Time: 10 minutes

Description: The instrument that measures sensitivity to pain and gives a numerical value is called an algometer. In total, application was made at 4 different points. Medial point of heel - Right Medial point of heel - Left Medial point of knee-Right Medial point of knee-Left Measurements were made three times and averaged.

Measure: Algometer

Time: 5 minutes

Description: Purpose and application of the test: The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into numericals. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line. Rest, activity and night were evaluated in three different time periods

Measure: Visual Analog Scale (VAS) Evaluation

Time: 5 minutes

Description: To determine fall risk and measure the progress of balance, sit to stand and walking.The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down.

Measure: Time up and go test

Time: 20 seconds

Description: The 30 Second Sit to Stand Test is also known as 30 second chair stand test ( 30CST), is for testing leg strength and endurance in older adults.The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.

Measure: 30 Seconds Sit To Stand Test

Time: 30 Seconds

Description: The individual is asked to climb and descend 7 times. The total time is recorded.

Measure: Step test

Time: 1 minute

Description: Lower extremity joints and range of motion were evaluated. Hip Flexion Hip Extension Hip Internal Rotation Hip External Rotation Knee Flexion Knee Extension Ankle Plantar Flexion Ankle Dorsi Flexion

Measure: goniometer

Time: 10 minutes

HPO Nodes


Reports

Data processed on December 13, 2020.

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