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PACE-LifeWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug882 Exercise Intervention Wiki 1.00

Correlated MeSH Terms (5)


Name (Synonyms) Correlation
D019967 Schizophrenia Spectrum and Other Psychotic Disorders NIH 1.00
D012559 Schizophrenia NIH 0.58
D011618 Psychotic Disorders NIH 0.50
D001523 Mental Disorders NIH 0.21
D004194 Disease NIH 0.18

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0100753 Schizophrenia HPO 0.58
HP:0000709 Psychosis HPO 0.50

There is one clinical trial.

Clinical Trials


1 Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial

Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 56 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart from the watch, which will be used to guide the intensity of the walk will be provided to participants and reviewed at each group session. Participants randomly assigned to PACE Life clinic based group sessions will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes. At the completion of 30 minutes, everyone will go back into the clinic for water and review of the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to come to the clinic to get assistance on any Fitibit or exercise related issues.

NCT04173572 Schizophrenia Schizoaffective Disorder Brief Psychotic Disorder Schizophreniform Disorders Unspecified Schizophrenia Spectrum and Other Psychotic Disorder Behavioral: PACE-Life Behavioral: Exercise Intervention
MeSH:Disease Schizophrenia Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders
HPO:Psychosis Schizophrenia

Primary Outcomes

Description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).

Measure: Difference in Participant's Total Distance During 6-minute Walk

Time: Baseline and the last study visit (Up to 20 weeks)

Secondary Outcomes

Description: Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.

Measure: Mean Difference in Minutes Spent Walking

Time: Baseline and the last study visit (up to 20 weeks)

Description: Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.

Measure: Mean Difference in Daily Steps

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).

Measure: Mean Difference Overall UCLA Loneliness Scale Score

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).

Measure: Mean Difference Overall PANSS Score

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).

Measure: Mean Difference in Body Weight Change

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).

Measure: Mean difference in blood pressure change

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).

Measure: Mean Difference in Resting Heart Rate Change

Time: Baseline and the last study visit (Up to 20 weeks)

Other Outcomes

Description: Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).

Measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2)

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).

Measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES)

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).

Measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES)

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).

Measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS)

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.

Measure: Mean Difference in Composite Score on the Autonomy Support Scale

Time: Baseline and the last study visit (Up to 20 weeks)

Description: Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.

Measure: End of Study Survey

Time: Post treatment only (16 weeks)


Related HPO nodes (Using clinical trials)