Trial Outcomes & Findings for Exercise and PTSD in Older Veterans (NCT NCT02295995)

Last Updated: 2020-01-29

Results Overview

The primary aim/outcome of this pilot study is the feasibility of recruiting older Veterans with PTSD to participate in a 12-week exercise program. The number of Veterans recruited out of the total number contacted will be determined at baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

Baseline

Results posted on

2020-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.	Usual Care Wait-List Participants randomized to this arm continued to receive usual care services for PTSD through the Veterans Health Administration (VHA) for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
Overall Study STARTED	36	18
Overall Study COMPLETED	31	17
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Exercise Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.	Usual Care Wait-List Participants randomized to this arm continued to receive usual care services for PTSD through the Veterans Health Administration (VHA) for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
Overall Study Lost to Follow-up	5	1

Baseline Characteristics

Exercise and PTSD in Older Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise n=36 Participants Participants randomized to this arm were enrolled in a 12-week, supervised exercise program.	Usual Care Wait-List n=18 Participants Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.	Total n=54 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 3.2 • n=5 Participants	66.9 years STANDARD_DEVIATION 4.3 • n=7 Participants	67.3 years STANDARD_DEVIATION 3.75 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	15 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	18 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	13 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
PTSD Checklist DSM-V (PTSD symptoms)	42.9 units on a scale STANDARD_DEVIATION 14.9 • n=5 Participants	41.1 units on a scale STANDARD_DEVIATION 14.0 • n=7 Participants	42.0 units on a scale STANDARD_DEVIATION 14.4 • n=5 Participants
Body Mass Index	30.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants	30.4 kg/m^2 STANDARD_DEVIATION 4.4 • n=7 Participants	30.5 kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 701 potentially eligible patients were identified, of which 380 were screened out. Leaving 321 eligible patients (the denominator). Of these 321, 168 declined participation, and 99 were unable to contact; leaving 54 that were enrolled/randomized (numerator).

Outcome measures

Outcome measures
Measure	Eligible Patients n=321 Participants Number of potentially eligible patients contacted to participate in the study.	Usual Care Wait-List Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
Feasibility of Patient Recruitment	54 Participants	—

PRIMARY outcome

Timeframe: Baseline and 12 Weeks

Activity levels (metabolic equivalent \[MET\]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire.

Outcome measures

Outcome measures
Measure	Eligible Patients n=31 Participants Number of potentially eligible patients contacted to participate in the study.	Usual Care Wait-List n=17 Participants Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
Physical Activity Baseline	365.8 metabolic equivalent (MET)-min/week Standard Error 349.4	349.4 metabolic equivalent (MET)-min/week Standard Error 122.2
Physical Activity 12 Weeks	1954.4 metabolic equivalent (MET)-min/week Standard Error 192.2	675.3 metabolic equivalent (MET)-min/week Standard Error 178.8

PRIMARY outcome

Timeframe: Baseline and 12 Weeks

PTSD symptom severity was assessed at both baseline and 12 Weeks using the PTSD Checklist for DSM-V (PCL-5). Scores on the PCL-5 range from 0 to 80, with higher scores indicating more severe PTSD symptoms.

Outcome measures

Outcome measures
Measure	Eligible Patients n=31 Participants Number of potentially eligible patients contacted to participate in the study.	Usual Care Wait-List n=17 Participants Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
PTSD Symptoms Baseline	42.97 score on a scale Standard Error 2.5	41.06 score on a scale Standard Error 3.5
PTSD Symptoms 12 Weeks	35.87 score on a scale Standard Error 2.4	38.19 score on a scale Standard Error 2.3

SECONDARY outcome

Timeframe: Baseline and 12 Weeks

Population: 2 participants in the usual care (UC) condition did not complete this test at 12 weeks, and were not included in this analysis.

Aerobic endurance was assessed using the 6-minute walk test (distance).

Outcome measures

Outcome measures
Measure	Eligible Patients n=31 Participants Number of potentially eligible patients contacted to participate in the study.	Usual Care Wait-List n=15 Participants Participants randomized to this arm continued to receive usual care services for PTSD through the VHA for 12 weeks after which time they will be offered the physical activity program for 12 weeks.
Aerobic Endurance Baseline	462.1 meters Standard Error 22.3	465.9 meters Standard Error 32.0
Aerobic Endurance 12 Weeks	531.1 meters Standard Error 29.8	476.0 meters Standard Error 21.7

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Wait-List

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katherine S. Hall

Durham VA HCS

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place