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D000073496: Frailty

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
drug2700 Museum virtual guided tours Wiki 0.33
drug3629 Relation between frailty and clinical outcomes in elderly patients with COVID-19. Wiki 0.33
drug4672 Virtual Group Exercise Wiki 0.33
Name (Synonyms) Correlation
drug2550 Medication Review Wiki 0.33
drug1429 ESOGER Wiki 0.33
drug2893 Nutrition education Wiki 0.33
drug4014 Socialization Wiki 0.33
drug2341 Lifestyle App Wiki 0.33
drug2891 Nutrition Consult and Protein Supplementation Wiki 0.33
drug3975 Simplified Geriatric Evaluation Wiki 0.33
drug1190 Covid-19 PCR , IGM Wiki 0.33
drug972 Chlorhexidine Gluconate Wiki 0.24
drug3870 Sampling Wiki 0.24
drug1569 Exercise program Wiki 0.19
drug4212 Survey Wiki 0.08

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D001835 Body Weight NIH 0.17
D051346 Mobility Limitation NIH 0.15
D006333 Heart Failure NIH 0.08
Name (Synonyms) Correlation
D007674 Kidney Diseases NIH 0.08
D008171 Lung Diseases, NIH 0.06
D002318 Cardiovascular Diseases NIH 0.05
D003920 Diabetes Mellitus, NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (6)


Name (Synonyms) Correlation
HP:0002355 Difficulty walking HPO 0.15
HP:0001635 Congestive heart failure HPO 0.08
HP:0000077 Abnormality of the kidney HPO 0.08
Name (Synonyms) Correlation
HP:0002088 Abnormal lung morphology HPO 0.06
HP:0001626 Abnormality of the cardiovascular system HPO 0.05
HP:0000819 Diabetes mellitus HPO 0.05

Clinical Trials

Navigate: Correlations   HPO

There are 9 clinical trials


1 Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events

The ANRS EP66 SEPTAVIH Study aims to screen feasibility of evaluating frailty in people living with HIV aged 70 or older, to estimate its prevalence, to analyse associated risk factors and to evaluate the impact of frailty on pejorative events. SEPTAVIH is a French, multicentre, prospective, observational study which will include 500 HIV-infected participants

NCT03958786
Conditions
  1. HIV Infections
Interventions
  1. Other: Simplified Geriatric Evaluation
  2. Other: Sampling
MeSH:Frailty

Primary Outcomes

Description: Proportion of patients classified as frail according to Fried at Baseline

Measure: Proportion of frail patients

Time: 12 months
2 First Level Socio-geriatric Evaluation in Period of Physical and Social Distancing in Frail Older Patients and Older Community Dwellers: ESOGER Databank

Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is one of the most effective ways to reduce the spread of COVID-19, but this key prevention intervention may have adverse consequences on older adults living at home. Screening older adults living at home and at risk for adverse consequences of physical and social distancing is, therefore, a priority in order to prevent their occurrence. ESOGER ("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen the risk-levels for adverse consequences related to COVID-19 physical distancing and 2) to continue appropriate preventive interventions in older adults living at home including frail older patients and older community dwellers. Experience cumulated during the past two weeks revealed that ESOGER could be improved, in order to be more effective and efficient for the prevention of adverse consequences related to COVID-19 physical distancing. This improvement is based on two key components: 1) Comments of Montreal ESOGER users and 2) Analysis of data. Because at this time no information is saved and stored, there is a need to save and store ESOGER information and create the ESOGER databank.

NCT04393649
Conditions
  1. COVID
  2. Social Isolation
  3. Anxiety
  4. Frailty
Interventions
  1. Other: ESOGER
MeSH:Frailty

Primary Outcomes

Description: presence or not of fever, cough and shortness of breath (binary question)

Measure: COVID-19 symptoms

Time: 1 day

Description: presence or not of a rupture of access to food, medication and home care (binary question)

Measure: issues related to medication and food delivery and access to home care

Time: 1 day

Description: Questionnaire Emergency Room Evaluation and Recommandation (ER2), score from 0 = no risk of frailty to 14 = high risk of frailty)

Measure: physical frailty

Time: 1 day

Description: anxiety Verbal analogic scale, score from 0 = no anxiety to 10 = extremely anxious)

Measure: psychological frailty

Time: 1 day

Secondary Outcomes

Description: Zarit scale, score from 0 = no caregiver burden to 16 = high caregiver burden)

Measure: Caregiver burden

Time: 1 day
3 Relationship Between Frailty and Clinical Outcomes in Elderly Patients With COVID-19

This is a monocentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19.

NCT04412265
Conditions
  1. Covid19
Interventions
  1. Other: Relation between frailty and clinical outcomes in elderly patients with COVID-19.
MeSH:Frailty

Primary Outcomes

Description: The aim of the project is to evaluate whether a tool built to measure frailty in elderly patients admitted to the COVID + hospital wards of San Gerardo hospital is more accurate in predicting clinical states than a clinical evaluation developed on age and comorbidity.

Measure: Development of a tool to measure frailty

Time: Until patient discharge from the hospital (approximately 1 year).

Secondary Outcomes

Description: Assess whether a "proxy" variable of the fragility index can be built on the basis of regional administrative databases only, which is able to predict the clinical outcomes of COVID + patients better than age and comorbidities alone.

Measure: A "proxy" variable of the fragility index can be built on the basis of regional administrative databases only.

Time: Until patient discharge from the hospital (approximately 1 year).

Description: Relate different levels of chronicity with the susceptibility of the elderly subject to infection to give elements to focus the screening policies for COVID19.

Measure: Give elements to focus the screening policies for COVID19.

Time: Until patient discharge from the hospital (approximately 1 year).

Description: Relate different levels of chronicity with the susceptibility of the elderly subject to infection to prevent the contagion at the elderly population level.

Measure: Give the prevention of contagion at the elderly population level.

Time: Until patient discharge from the hospital (approximately 1 year).
4 Implementation of the Integrated Care of Older People App and ICOPE Monitor in Primary Care (ICOPE)

Introduction: The World Health Organization has launched the INSPIRE-ICOPE-CARE program towards healthy aging. It includes "intrinsic capacity", defined as "the composite of all the physical and mental capacities of an individual", which has a positive value towards prevention, and is constructed by five domains: cognition, vitality/nutrition, sensory, psychology, and mobility. ICOPE App and ICOPE Monitor are applications for the self-assessment and monitoring of intrinsic capacity. Hypothesis: Intrinsic capacity self-assessed by the ICOPE Apps could be associated with the incidence of frailty and health outcomes. ICOPE Apps might support geriatric and primary care during the COVID-19 pandemic and beyond. Objectives: To assess the association between intrinsic capacity measured by the ICOPE Apps at baseline and the incidence of frailty in community-dwelling older adults during 1-year follow-up. Secondarily, to assess the association of intrinsic capacity and pre-frailty, falls, functional decline, institutionalization, and mortality (COVID-19-related/not related). Methods: Protocol for a cohort study of community-dwelling adults ≥65-year-old, with no other exclusion criteria than the inability to use the Apps or communicate by telephone/video-call for any reason (cognitive or limited access to telephone/video-call). Intrinsic capacity measured by the ICOPE Apps and Rockwood's clinical frailty scale will be assessed at baseline, 4-, 8- and 12-month follow-up by telephone/video-call. Assuming a prevalence of frailty of 10.7%, and incidence of 13% (alpha-risk=0.05), 400 participants at 12-month end-point (relative precision=0.10) and 600 participants at baseline will be required. Associations among the decrease in intrinsic capacity, incidence of frailty, and occurrence of health adverse outcomes during 1-year follow-up are expected. ICOPE Apps might identify individuals at higher risk of frailty and health adverse consequences. The implementation of the ICOPE Apps into clinical practice might help to bring the practitioners closer to their patients, deliver efficient person-centered care-plans, and benefit the healthcare systems during the COVID-19 pandemic and beyond.

NCT04413877
Conditions
  1. Frailty Syndrome
  2. COVID-19
  3. Healthy Aging
  4. Old Age; Debility
MeSH:Frailty

Primary Outcomes

Description: Incidence of frailty assessed by Rockwood's clinical frailty scale (CFS) will be assessed at baseline and 12-month follow-up by telephone/video-call. An score <4 will indicate robustness, 4-6 pre-frailty status, and ≥6 frailty

Measure: Incidence of frailty

Time: 1 year
5 Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study

The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or reduce frailty. Frailty occurs in older adults and leads people to have falls, become disabled, require nursing home placement, and have increased risk of death. T2D is one of the major risk factors for frailty. T2D is a significant problem in older adults and is known to increase the risk of future frailty.

NCT04440449
Conditions
  1. Frailty
  2. Weight, Body
  3. Type 2 Diabetes
Interventions
  1. Behavioral: Lifestyle App
MeSH:Diabetes Mellitus Frailty Body Weight
HPO:Diabetes mellitus

Primary Outcomes

Description: Change in frailty measured on a scale using a frailty score (0, 1, 2, 3, 4,or 5), with higher scores out of 5 representing greater frailty. Assessments used for scoring include 1) self reported weight loss, 2) self-reported exhaustion 3) low physical activity based on the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) 4) Handgrip strength 5) 10 foot walk pace

Measure: Frailty Scale

Time: Baseline to 6 months

Secondary Outcomes

Description: Change in HbA1c measured over the study period

Measure: Glycated hemoglobin (HbA1c)

Time: Baseline to 6 months

Description: For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

Measure: Patient-Reported Outcomes Measurement Information System (PROMIS)

Time: Baseline to 6 months

Description: The study team will administer the Short Physical Performance Battery (SPPB)69 to assess three lower extremity tasks; 1) standing balance (ability to stand with the feet together in side-by-side, semi-and full-tandem positions for 10 seconds each); 2) a 4-meter walk to assess usual gait speed; 3) time to complete 5 repeated chair stand. Each of the 3 performance measures is assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create a score ranging from 0 to 12 (best). The SPPB is sensitive to change over time

Measure: Short Physical Performance Battery (SPPB)

Time: Baseline to 6 months
6 GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19

The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a toll on physical and mental health. Many healthcare professionals are concerned vulnerable seniors may become deconditioned, which substantially increases risk of health complications and need for hospitalization. To address the immediate impact of COVID-19 policies (i.e., physical distancing, reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. The investigators' aim is to understand how to best build resilience among vulnerable seniors in the community through at-home rehabilitation services (socialization, exercise, nutrition, and medication support).

NCT04500366
Conditions
  1. Frailty
Interventions
  1. Behavioral: Socialization
  2. Behavioral: Virtual Group Exercise
  3. Combination Product: Nutrition Consult and Protein Supplementation
  4. Behavioral: Medication Review
MeSH:Frailty

Primary Outcomes

Description: Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.

Measure: Change in Physical Function

Time: Baseline and 12 Weeks Post-Intervention

Description: Assessed by the Depression Anxiety Stress Scale (DASS-21). Higher scores indicate greater risk of depression, anxiety and stress [depression, anxiety, stress subscores range 0-21].

Measure: Change in Mental Health

Time: Baseline and 12 Weeks Post-Intervention

Secondary Outcomes

Description: Assessed by the SARC-F - Self-reported strength, assistance with walking, rising from a chair, climbing stairs and falls. Higher scores indicate greater level of sarcopenia [range 0-10].

Measure: Change in Sarcopenia

Time: Baseline and 12 Weeks Post-Intervention

Description: Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].

Measure: Change in Frailty

Time: Baseline and 12 Weeks Post-Intervention

Description: Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence [range 0-100].

Measure: Change in Self-Efficacy

Time: Baseline and 12 Weeks Post-Intervention

Description: Assessed by the interRAI Community Rehab Assessment - Self-Report

Measure: Self-Reported Change in Function, Health and Well-Being

Time: Baseline and 12 Weeks Post-Intervention

Description: Assessed by the interRAI Community Rehab Assessment - Clinician-Completed

Measure: Clinician-Reported Change in Function, Health and Well-Being

Time: Baseline and 12 Weeks Post-Intervention

Description: Assessed by the Borg Rate of Perceived Exertion after exercise. Higher scores indicate greater level of exertion [range 6-20]. Also assessed using accelerometers (heart rate, sedentary time, physical activity time, energy expenditure).

Measure: Change in Fitness

Time: Weekly up to 12 weeks

Description: Assessed using a program questionnaire in accordance with the Kirkpatrick 5-Level Evaluation Model. Scores will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree".

Measure: Program Satisfaction

Time: 12 Weeks Post-Intervention

Description: Assessed by the EQ-5D-5L scale. Lower scores indicate better self-reported quality of life [range 0-100].

Measure: Change in Health-Related Quality of Life

Time: Baseline and 12 Weeks Post-Intervention

Description: Assessed by the Subjective Global Assessment. Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment.

Measure: Change in Nutrition

Time: Baseline and 12 Weeks Post-Intervention

Description: Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.

Measure: Change in Emergency Room Visits

Time: Baseline and 12 Weeks Post-Intervention

Description: Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.

Measure: Change in Hospitalizations

Time: Baseline and 12 Weeks Post-Intervention

Description: Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.

Measure: Change in Number of Calls to 911

Time: Baseline and 12 Weeks Post-Intervention

Other Outcomes

Description: Assessed by the number of individuals who participated. Target reach is 70 participants.

Measure: Feasibility Outcome #1 - Reach of intervention

Time: 12 Weeks Post-Intervention

Description: Assessed by number of referral sites. Target is 5 referral sites.

Measure: Feasibility Outcome #2 - Adoption of the Intervention

Time: 12 Weeks Post-Intervention

Description: Assessed by the number of individuals who completed the intervention. Higher number of individuals completing the study indicates greater success in implementation.

Measure: Feasibility Outcome #3 - Implementation of the Intervention

Time: 12 Weeks Post-Intervention

Description: Assessed by the number of referral sites continuing with a second cohort. Greater number of referral sites continuing with a second cohort indicates greater maintenance.

Measure: Feasibility Outcome #4 - Maintenance of the Intervention

Time: 12 Weeks Post-Intervention
7 A 3-month Cycle of Virtual Weekly Montreal Museum of Fine Arts Tours to Promote Social Inclusion, Well-being, Quality of Life and Health in Older Community Members : a Pilot Study

Social isolation is defined as the objective and/or subjective reduction of number and quality of interpersonal contacts leading to a loss of an individual's social role and stigmatization. It is a major problem in Canadian society with a high prevalence in the older population (30% in individuals aged 65 and over, representing 1.5 million individuals). Social isolation is associated with a wide range of mental and physical health problems that leads to an increase in the use of health and social services. This issue increased with the coronavirus disease (COVID-19) pandemic which attacking your society at its core. Social distancing and in particular home confinement exacerbated social isolation of frailer groups like the elderly people. In 2016, the International Federation on Ageing reported that "the main new problem facing seniors in Canada is maintaining their social contacts and activities". This highlights the need for efficient and effective interventions to improve the social inclusion of older adults experiencing social isolation. Research suggests that art-based activities carried out at museums have significant benefits for older adults experiencing social isolation, and may foster social inclusion, well-being, quality of life and mitigate frailty. Yet few studies have examined empirically the effects of museum art-based activities in older adults experiencing social isolation. In 2019, the principal investigator of this research conducted an experimental pilot study based on a pre-post intervention (i.e., 3-month cycle of weekly guided tours carried out at the Montreal Museum of Fine Arts (MMFA)), single arm, prospective and longitudinal follow-up named "Effects of Montreal Museum of Fine Arts visits and older community dwellers with a precarious state: An experimental study", which indicated the potential of museum tours to improve social inclusion, well-being, the quality of life and frailty in older community members experiencing social isolation. However, these studies were performed before the COVID-19 crisis and were in-site activities. The principal investigator hypothesizes that a 3-month cycle of virtual weekly MMFA tours may induce changes in well-being, quality of life and health condition in older community dwellers participating like the 'Beautiful Thursday' cycle, and that this activity can prevent the worsening of vulnerability and social isolation due to social distancing.

NCT04593433
Conditions
  1. Social Isolation
  2. Quality of Life
  3. Well Aging
  4. Frailty
Interventions
  1. Other: Museum virtual guided tours
MeSH:Frailty

Primary Outcomes

Description: using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) self-validated questionnaire composed by 14 positively worded item scale with five response categories. It covers most aspects of positive mental health (positive thoughts and feelings). Scores can range from a minimum of 14 to a maximum of 70 points. Higher scores are associated with higher levels of mental well-being

Measure: Well-being

Time: 3 months

Description: using EuroQol-5D (EQ-5D), a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. It is composed of two parts: a questionnaire of five questions with score per question ranged from 1 (i.e., no issue) to 5 (i.e., worse issue), each question ranged from 0 (i.e., no issue) to 25 (i.e., worse issue), and a visual analogic scale of how good or bad participant health was. This scale is numbered from 0 (i.e., worse health participant can imagine) to 100 (i.e., best health participant can imagine).

Measure: Quality of life

Time: 3 months

Description: using CESAM questionnaire, composed of 20 items providing two complementary information: 1) A global score of frailty ranged from 0 (i.e., best health and functional condition) to 18 (i.e., worse health and functional condition) and 2) Categorized health condition in four levels (vigorous with a score between 0 and 3, mild frailty with a score between 4 and 7, moderate frailty with a score between 8 and 12, and important frailty with a score above 12).

Measure: frailty

Time: 3 months

Description: using the digital form of the 11-item Dike Social Support Index (DSSI). The index is composed of two subscales: social interaction (i.e., frequency of interactions) and subjective support (i.e., satisfaction with emotional support provided). DSSI score ranges from 11 to 33, increased score indicating higher levels of social insertion. The scores of the 11 items are combined and categorized as low-fair (score ≤26), high (score 27-29) and very high (score 30-33). We will use the mean score of 11-item DSSI and its distribution in three categories.

Measure: social isolation

Time: 3 months

Description: using ESOGER questionnaire, composed of 17 items exploring the COVID risk, the COVID past history, the social isolation risk due to COVID (access to food, home support and healthcare, contact with external persons, anxiety). Items correspond to a question in closed-ended format (i.e., yes or no, or calling for a specific answer). The ESOGER categorizes state of vulnerability in three levels (Low, Moderate and High vulnerability).

Measure: socio-geriatric vulnerability

Time: 3 months

Secondary Outcomes

Description: recorded at the end of the cycle by asking directly to the participants

Measure: Incident planned and unplanned visits to physicians, Emergency Department (ED) and hospitalization

Time: 3 months

Description: determined by the total number of guided tours performed, on a maximum of 12.

Measure: compliance

Time: 3 months
8 Functional Recovery of Older Hospitalised Patients With COVID-19: a Prospective and Retrospective Cohort Study Extension to the Coronavirus Registry (COREG)

Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Although there has been a rapid response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Older adults who survive the diseases are at risk of developing persistent mobility limitations due to extensive bed rest during hospitalization. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.

NCT04602260
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Mobility Limitation
  4. Frailty
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Frailty Mobility Limitation
HPO:Difficulty walking

Primary Outcomes

Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version

Time: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)

Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Outpatient Version

Time: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function), and at 3,6,9 and 12-months post hospital discharge

Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Applied Cognitive Inpatient Version

Time: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)

Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Daily Activity

Time: 3,6,9 and 12-months post hospital discharge

Secondary Outcomes

Description: The SPPB combines the results of gait speed over 3 meters, the 5-repetition chair-stand, and a progressive balance test to assess lower extremity function.

Measure: Change in Short Physical Performance Battery (SPPB)

Time: 3,6,9 and 12-months post hospital discharge

Description: The CFS is an interview-based scale wherein the assessor may ask the patient questions about things such as their independence or physical abilities to determine where the patient falls along the 9-point scale, from 1 (Very Fit) to 9 (Terminally Ill).

Measure: Change in Clinical Frailty Scale (CFS) for participants over 60 years of age

Time: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function ), and at 3,6,9 and 12-months post hospital discharge

Description: The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation as measured by spirometry.

Measure: Change in Forced Expiratory Volume (FEV1)

Time: 3,6,9 and 12-months post hospital discharge

Description: The amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry. FVC is the total amount of air exhaled during the FEV test.

Measure: Change in Forced Vital Capacity (FVC)

Time: 3,6,9 and 12-months post hospital discharge

Description: The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value.

Measure: Change in Forced Expiratory Volume Percentage (FEV1%)

Time: 3,6,9 and 12-months post hospital discharge

Description: The BDI rates the severity of dyspnea at a single point in time (baseline) based on a 24-item interviewer administered rating scale.

Measure: Baseline Dyspnea Index (BDI)

Time: 3 months post hospital discharge

Description: Measures changes in dyspnea severity from the baseline as established by the BDI.

Measure: Change in Transition Dyspnea Index (TDI)

Time: 6,9 and 12-months post hospital discharge

Description: The PHQ-9 is a self-rating instrument for depression based on nine questions that the patient responds to by indicating how much they have been bothered by these symptoms over the last two weeks.

Measure: Change in Patient Health Questionnaire - 9 (PHQ-9)

Time: 3,6,9 and 12-months post hospital discharge

Description: The FIM assesses the functional status of a person based on the level of assistance the person requires.

Measure: Change in Functional Independence Measure (FIM)

Time: 3 and 6 months post hospital discharge

Description: The IES-R is a 22-item self-report measure that asks questions about subjective distress caused by traumatic events. Each item is rated on a 5-point scale, from 0 ("not at all") to 4 ("extremely").

Measure: Change in Impact of Event Scale - Revised (IES-R)

Time: 3,6,9 and 12-months post hospital discharge

Description: The EQ-5D-5L is a generic and well-established instrument for describing health status or disease-specific outcome measures. It defines health in terms of five dimensions: Mobility, Self- Care, Usual Activities, Pain/Discomfort, and Anxiety/ Depression. The response options are of five levels, from no, slight, moderate, severe, to extreme problems

Measure: Change in Health status (EQ-5D-5L)

Time: 3,6,9 and 12-months post hospital discharge
9 MoveStrong at Home: A Model for Remote Delivery of Strength Training and Nutrition Education for Older Adults in Canada, A Pilot Study

Sufficient muscle strength helps to get out of a chair and can prevent falls. Up to 30% of older adults experience age-related loss of muscle strength, which can lead to frailty and health instability. Exercise helps to build muscle, maintain bone density and prevent chronic disease, especially during the aging process. In older adults at risk of mobility impairment, exercise greatly reduced incidence and effects did not vary by frailty status. However, more than 75% of Canadian adults ≥18 years of age are not meeting physical activity guidelines. In addition, it is known know that malnutrition, including low protein intake, may lead to poor physical function. While there are services to support exercise and nutrition, barriers to implementing them persist. The COVID-19 pandemic has exacerbated the potential for physical inactivity, malnutrition, and loneliness among older adults, especially those with pre-existing health or mobility impairments. Now and in future, alternate ways to promote exercise and proper nutrition to the most vulnerable are needed. The investigators propose to adapt MoveStrong, an 8-week education program combining functional strength and balance training with strategies to increase protein intake. The program was co-developed with patient advocates, Osteoporosis Canada, the YMCA, Community Support Connections and others. MoveStrong will be delivered by telephone or web conference to older adults in their homes, using mailed program instructions, 1-on-1 training sessions through Physitrack®, as well as online nutrition seminars and support groups over Microsoft® Teams. The primary aim of this study is to assess feasibility as determined by recruitment (25 people in 3 months), retention (80%), adherence (≥70%) and participant experience.

NCT04663685
Conditions
  1. Arthritis
  2. Cancer
  3. Cardiovascular Diseases
  4. Chronic Lung Disease
  5. Congestive Heart Failure
  6. Diabetes
  7. Hypertension
  8. Kidney Diseases
  9. Obesity
  10. Osteoporosis
  11. Stroke
  12. Frailty
Interventions
  1. Other: Exercise program
  2. Other: Nutrition education
MeSH:Osteoporosis Lung Diseases Kidney Diseases Heart Failure Cardiovascular Diseases Frailty
HPO:Abnormal left ventricular function Abnormal lung morphology Abnormality of the cardiovascular system Abnormality of the kidney Congestive heart failure Nephropathy Right ventricular failure

Primary Outcomes

Description: The number of participants recruited at the end of rollout and participant experience.

Measure: Recruitment

Time: Through study completion, an average of 12 weeks

Description: The number of participants retained at post-rollout end

Measure: Retention

Time: Through study completion, an average of 12 weeks

Description: The percentage of exercise sessions completed

Measure: Adherence

Time: Through study completion, an average of 12 weeks

Description: A semi-structured interview will ask about participant experience, satisfaction, learning needs, and suggested adaptations to the program. A semi-structured interview guide has been designed to conduct exit interviews and follow up interviews with each participant over the phone or web conference. Interviews will be audio-recorded and transcribed verbatim. One researcher will perform content analyses using NVivo version 12 Pro or higher (QSR International Pty Ltd, 2019) to describe participant experience, satisfaction, learning needs and suggested adaptations to the program. Analyses will be verified by another researcher through member checking. The exercise physiologist will be given a spreadsheet to record any protocol adaptations, challenges, and successes to inform future trials.

Measure: Participant experience

Time: Week 12

Secondary Outcomes

Description: A Physical Activity Screen (PAS) will be used to capture average minutes of moderate-to-vigorous physical activity each week. This tool was created based on questions used by Exercise is Medicine in the Physical Activity Vital Sign questionnaire (Greenwood et al., 2010). The results will be compared to national exercise guidelines for older adults that promote ≥150 minutes and ≥2 session of muscle strengthening per week (Tremblay et al., 2011).

Measure: Physical activity

Time: Baseline, week 9, week 12

Description: A modified version of the Exercise Self-Efficacy Scale will be used to capture levels of planning and execution of exercise related activities (Resnick & Jenkins, 2000). The lowest response option to each question is "Not true at all", while the highest is "Exactly true". Responses closer to "Exactly true" indicate a better outcome.

Measure: Exercise self-efficacy scale

Time: Baseline, week 9, week 12

Description: The 30-second Chair Stand will be used to access lower extremity muscle function (Bohannon, 1995; Jones et al., 1999). The instructions for this test have been adapted and will be self-administered under the remote supervisor supervision of the exercise physiologist. A higher score on this test indicates a better outcome.

Measure: 30-second Chair Stand

Time: Baseline, week 9, week 12

Description: Static balance will be measured using the 3-point scale from the Short Performance Physical Battery (J. M. Guralnik et al., 1994). The instructions for this test have been adapted and will be self-administered under the remote supervisor supervision of the exercise physiologist. A higher score on this test indicates a better outcome.

Measure: Static balance

Time: Baseline, week 9, week 12

Description: Fatigue will be assessed with the Center for Epidemiologic Studies Depression Scale-fatigue questions (CES-D) Depression Scale (Radloff, 1977). Only two questions on the CES-D will be used: "I felt that everything I did was an effort, "I could not get going". The lowest response option is "Rarely (<1 day)", and the highest response option is "Nearly every day". Responses closer to the lowest response option indicate a better outcome.

Measure: Fatigue

Time: Baseline, week 9, week 12

Description: Warwick-Edinburgh Mental Well-being Scale focuses on positive aspects of mental health. It is short, yet robust and showed high correlations with other mental health and well-being scales. The lowest response option is "None of the time", and the highest response option is "All of the time". Responses closer to the highest response option indicate a better outcome.

Measure: Mental health and social isolation

Time: Baseline, week 9, week 12

Description: The EuroQol Group 5 Dimension 5 Level questionnaire is a multi-attribute health related quality of life tool (Herdman et al., 2011). The system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems to extreme problems five dimensions can be combined into a 5-digit number that describes the self rated patient's health state. Responses to each dimension are scored as a number from 1-5. Responses scored as 1 indicate a better outcome.

Measure: Quality of life score

Time: Baseline, week 9, week 12

Description: The SCREEN tool is a valid and reliable nutrition questionnaire designed specifically for older adults (Keller et al., 2005). This tool will be used to assess changes in weight, appetite, eating habits and promote viable self-management.

Measure: Dietary intake

Time: Baseline, week 9, week 12

Description: ASA24®-Canada is a guided web-based tool used for 24-hour diet recalls. All food and drinks consumed by the participant on two weekdays and one weekend day (3 days in total) will be reported to track protein intake (Subar et al., 2012).

Measure: Nutrition tracking

Time: Baseline, week 9, week 12

Description: We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.

Measure: Number of adverse events

Time: Through study completion, an average of 12 weeks

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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