Trial Outcomes & Findings for Peer Support for Exercise in Older Veterans With Psychotic Disorders (NCT NCT02958007)
NCT ID: NCT02958007
Last Updated: 2023-09-25
Results Overview
Percent of participants randomized to PEER who attend at least three group sessions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-09-25
Participant Flow
Participant milestones
| Measure |
Peer Education on Exercise for Recovery
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Peer Education on Exercise for Recovery: A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
Enhanced Supervised Fitness Training
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
Enhanced supervised fitness training: A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peer Support for Exercise in Older Veterans With Psychotic Disorders
Baseline characteristics by cohort
| Measure |
Peer Education on Exercise for Recovery
n=11 Participants
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Peer Education on Exercise for Recovery: A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
Enhanced Supervised Fitness Training
n=11 Participants
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
Enhanced supervised fitness training: A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 4.1 • n=93 Participants
|
64.4 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
62.8 years
STANDARD_DEVIATION 6.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
11 participants
n=4 Participants
|
22 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPercent of participants randomized to PEER who attend at least three group sessions
Outcome measures
| Measure |
Peer Education on Exercise for Recovery
n=11 Participants
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Peer Education on Exercise for Recovery: A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
Enhanced Supervised Fitness Training
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
Enhanced supervised fitness training: A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
|---|---|---|
|
Intervention Engagement
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 25% of recorded group sessions randomly selected and reviewed by independent rater for fidelity
Percent of sampled PEER group sessions in which the peer coaches were adequately adherent, as per the PEER Fidelity Measure. This measure includes content items (e.g., "How well did facilitators review the educational topic of the day") and process items (e.g., "How well did facilitators provide positive feedback and reinforcement throughout the class?") Each item is rated as 0 (unacceptable), 1 (acceptable), or 2 (excellent), and then an average score is calculated. Adequate adherence was defined as an average score of 1 or greater and no items rated as unacceptable.
Outcome measures
| Measure |
Peer Education on Exercise for Recovery
n=13 Recorded group sessions
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Peer Education on Exercise for Recovery: A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
Enhanced Supervised Fitness Training
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
Enhanced supervised fitness training: A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
|---|---|---|
|
Intervention Fidelity
|
11 Recorded group sessions
|
—
|
PRIMARY outcome
Timeframe: 12 weeksAttendance- mean number of supervised fitness training sessions attended
Outcome measures
| Measure |
Peer Education on Exercise for Recovery
n=11 Participants
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Peer Education on Exercise for Recovery: A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
Enhanced Supervised Fitness Training
n=11 Participants
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
Enhanced supervised fitness training: A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
|---|---|---|
|
Attendance
|
11.8 sessions
Standard Deviation 10.6
|
9.5 sessions
Standard Deviation 7.1
|
Adverse Events
Peer Education on Exercise for Recovery
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Enhanced Supervised Fitness Training
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peer Education on Exercise for Recovery
n=11 participants at risk
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Peer Education on Exercise for Recovery: A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
Enhanced Supervised Fitness Training
n=11 participants at risk
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
Enhanced supervised fitness training: A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic respiratory failure- unrelated to study
|
0.00%
0/11 • 24 weeks following randomization
|
9.1%
1/11 • Number of events 1 • 24 weeks following randomization
|
Other adverse events
| Measure |
Peer Education on Exercise for Recovery
n=11 participants at risk
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Peer Education on Exercise for Recovery: A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
Enhanced Supervised Fitness Training
n=11 participants at risk
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
Enhanced supervised fitness training: A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
27.3%
3/11 • Number of events 4 • 24 weeks following randomization
|
18.2%
2/11 • Number of events 4 • 24 weeks following randomization
|
|
Nervous system disorders
Lightheaded during exercise
|
9.1%
1/11 • Number of events 1 • 24 weeks following randomization
|
0.00%
0/11 • 24 weeks following randomization
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/11 • 24 weeks following randomization
|
9.1%
1/11 • Number of events 1 • 24 weeks following randomization
|
|
Musculoskeletal and connective tissue disorders
Fell in his home
|
0.00%
0/11 • 24 weeks following randomization
|
9.1%
1/11 • Number of events 1 • 24 weeks following randomization
|
|
Skin and subcutaneous tissue disorders
Leg wound- unrelated to exercise
|
9.1%
1/11 • Number of events 1 • 24 weeks following randomization
|
0.00%
0/11 • 24 weeks following randomization
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/11 • 24 weeks following randomization
|
9.1%
1/11 • Number of events 1 • 24 weeks following randomization
|
|
Gastrointestinal disorders
Hernia- unrelated to study
|
9.1%
1/11 • Number of events 1 • 24 weeks following randomization
|
0.00%
0/11 • 24 weeks following randomization
|
|
Psychiatric disorders
Anxious distress at gym
|
0.00%
0/11 • 24 weeks following randomization
|
9.1%
1/11 • Number of events 1 • 24 weeks following randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place