Trial Outcomes & Findings for Increasing Activity for Veterans With PTSD (NCT NCT04383496)

Results Overview

total participants enrolled in intervention (out of total patients identified as eligible)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

2 months

Results posted on

2025-03-04

Participant Flow

Goal recruitment was 6-8 participants for each of 3 pilot groups (max 24 total). The actual number of participants enrolled reflects those who completed informed consent and attended the baseline assessment and education session with the physical therapist (6, 8, and 7 for 3 groups). Because this was a group intervention, if participants failed to attend the informed consent or baseline visit (including attempts at rescheduling), we were unable to recruit additional participants for that group.

24 participants completed informed consent and were enrolled but only 21 completed the baseline visits (required before moving onto the intervention)

Participant milestones

Participant milestones
Measure	Physical Activity In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Increasing Activity for Veterans With PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Activity n=21 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	53.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian or Native Hawaiian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latino	1 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Data represents the total number of participants who completed informed consent

total participants enrolled in intervention (out of total patients identified as eligible)

Outcome measures

Outcome measures
Measure	Physical Activity n=212 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Recruitment	24 Participants

SECONDARY outcome

Timeframe: 4 months

Population: Participants who enrolled in study and were invited to interviews

Number of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance

Outcome measures

Outcome measures
Measure	Physical Activity n=21 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Total # Participants Completing Acceptability Interviews	19 Participants

SECONDARY outcome

Timeframe: 1 month

Number of participants who attended 75% of session visits (3 out of 4 group sessions; 5 of 7 individual follow-up calls)

Outcome measures

Outcome measures
Measure	Physical Activity n=21 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Attendance Attendance at Group Sessions	19 Participants
Attendance Attendance at Individual Follow-up	20 Participants

SECONDARY outcome

Timeframe: 4 months

Number of participants who complete post-intervention assessments at 4 months follow-up

Outcome measures

Outcome measures
Measure	Physical Activity n=21 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Retention	17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 months

Activity tracking (wearable device), number of days meeting activity goal (per week) at 8 weeks

Outcome measures

Outcome measures
Measure	Physical Activity n=19 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Physical Activity	3.41 days meeting activity goal/week Standard Deviation 1.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: Participants who completed 4 months follow-up surveys

Physical Component Score of Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning

Outcome measures

Outcome measures
Measure	Physical Activity n=9 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Physical Functioning	30.9 units on a scale Standard Deviation 5.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: Complete baseline and follow-up data

PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse)

Outcome measures

Outcome measures
Measure	Physical Activity n=17 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
PTSD Symptoms	49.6 units on a scale Standard Deviation 16.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: complete follow-up data

Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse)

Outcome measures

Outcome measures
Measure	Physical Activity n=16 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Depressive Symptoms	7.63 units on a scale Standard Deviation 5.54

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: complete follow-up data

PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference

Outcome measures

Outcome measures
Measure	Physical Activity n=16 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Pain Intensity and Interference	5.1 units on a scale Standard Deviation 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: participants with complete follow-up data

Patient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue

Outcome measures

Outcome measures
Measure	Physical Activity n=15 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Fatigue	55.8 score on a scale Standard Deviation 11.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: complete follow-up data

PROMIS sleep measure, standardized T score (0-100), higher is poorer sleep

Outcome measures

Outcome measures
Measure	Physical Activity n=15 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Sleep-related Impairment	56.7 score on a scale Standard Deviation 11.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: complete follow-up data

distance walked in 6 min (in meters)

Outcome measures

Outcome measures
Measure	Physical Activity n=17 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
6 Minute Walk	539 meters Standard Deviation 114

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: complete follow-up data

\# of sit-to-stands completed in 30 seconds

Outcome measures

Outcome measures
Measure	Physical Activity n=17 Participants In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Sit to Stand	19.1 sit-to-stand events Standard Deviation 9.6

Adverse Events

Physical Activity

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Physical Activity n=21 participants at risk In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
Skin and subcutaneous tissue disorders Skin irritation at wrist due to wearing fitness device	4.8% 1/21 • Number of events 1 • 4 months

Additional Information

Wei Duan-Porter

Minneapolis VA Health Care System

Phone: 6124675845

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place