Post-traumatic
Conditions
Keywords
Aged, Exercise, Veterans, Adherence, Clinical Trials, Randomized
Brief summary
The purpose of this study is to examine whether posttraumatic stress disorder (PTSD) symptoms impact adherence to a 12-week physical activity program and whether exercise can help improve PTSD symptoms and health outcomes in older Veterans. Veterans over the age of 60 with PTSD were be recruited to participate in a 12-week physical activity program consisting of aerobic and strengthening activities. 54 participants were randomized to an intervention arm (n=36) or usual care wait-list control (n=18).
Detailed description
There is substantial evidence that physical inactivity contributes to poorer physical health outcomes in older adults. There is a paucity of work examining physical activity in Veterans with PTSD. Consequently, the efficacy of exercise as a beneficial adjunctive therapy in the treatment for PTSD symptoms and related health sequelae has not been established. Methods: Approximately 50 Veterans 60 years and older with PTSD will be recruited to participate in a 12-week physical activity program consisting of aerobic and strength-training activities. Participants will be randomized to an intervention arm or usual care wait-list control. Outcomes: Changes in physical function, PTSD symptom severity, and aerobic endurance will be assessed between the two study arms. Summary: This pilot trial will extend the investigators' understanding of the physical and psychological benefits of physical activity in Veterans with PTSD. The results from this study will be used to be used to develop a larger, randomized controlled exercise trial for Veterans with PTSD. Once new, effective exercise therapies for Veterans with PTSD are established, we can augment traditional PTSD therapy with exercise therapy to promote the prevention and treatment of chronic diseases common in this vulnerable population.
Interventions
BEHAVIORALExercise as an Adjuvant Therapy for Veterans with PTSD
Methods: Approximately 50 Veterans 60 years and older with PTSD will be recruited to participate in a 12-week physical activity program consisting of aerobic and strength-training activities. Participants will be randomized to an intervention arm or usual care wait-list control. Outcomes: Changes in physical function, PTSD symptom severity, and aerobic endurance will be assessed between the two study arms. Secondary outcomes include compliance with the intervention, pain, sleep, and psychological well-being.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet diagnostic criteria for current PTSD, * live within 50 miles of Durham VA Medical Center (VAMC) and have reliable transportation, * registered for care at the Durham VAMC, * independently mobile (assistive devices acceptable), * speak and write fluent conversational English
Exclusion criteria
* Active substance dependence other than nicotine, * cognitive impairment, uncontrolled psychotic symptoms, * clinical history of cardiovascular disease (CVD) occurring within the past 3 months, * uncontrolled hypertension, * renal disease or currently receiving dialysis, * psychotropic medication initiated within 6 weeks prior to enrollment * proliferative retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Patient Recruitment | Baseline | 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. |
| Physical Activity | Baseline and 12 Weeks | Activity levels (metabolic equivalent \[MET\]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire. |
| PTSD Symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic Endurance | Baseline and 12 Weeks | Aerobic endurance was assessed using the 6-minute walk test (distance). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Participants randomized to this arm were enrolled in a 12-week, supervised exercise program. | 36 |
| 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. | 18 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 |
Baseline characteristics
| Characteristic | Exercise | Total | Usual Care Wait-List |
|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 3.2 | 67.3 years STANDARD_DEVIATION 3.75 | 66.9 years STANDARD_DEVIATION 4.3 |
| Body Mass Index | 30.6 kg/m^2 STANDARD_DEVIATION 5.9 | 30.5 kg/m^2 STANDARD_DEVIATION 5.1 | 30.4 kg/m^2 STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 54 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PTSD Checklist DSM-V (PTSD symptoms) | 42.9 units on a scale STANDARD_DEVIATION 14.9 | 42.0 units on a scale STANDARD_DEVIATION 14.4 | 41.1 units on a scale STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 46 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 34 Participants | 49 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 17 |
| other Total, other adverse events | 0 / 31 | 0 / 17 |
| serious Total, serious adverse events | 0 / 31 | 0 / 17 |
Outcome results
Primary
Feasibility of Patient Recruitment
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.
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Feasibility of Patient Recruitment | 54 Participants |
Primary
Physical Activity
Activity levels (metabolic equivalent \[MET\]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire.
Time frame: Baseline and 12 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Patients | Physical Activity | Baseline | 365.8 metabolic equivalent (MET)-min/week | Standard Error 349.4 |
| Eligible Patients | Physical Activity | 12 Weeks | 1954.4 metabolic equivalent (MET)-min/week | Standard Error 192.2 |
| Usual Care Wait-List | Physical Activity | Baseline | 349.4 metabolic equivalent (MET)-min/week | Standard Error 122.2 |
| Usual Care Wait-List | Physical Activity | 12 Weeks | 675.3 metabolic equivalent (MET)-min/week | Standard Error 178.8 |
Comparison: The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for physical activity in this sample was 1.37
Primary
PTSD Symptoms
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.
Time frame: Baseline and 12 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Patients | PTSD Symptoms | Baseline | 42.97 score on a scale | Standard Error 2.5 |
| Eligible Patients | PTSD Symptoms | 12 Weeks | 35.87 score on a scale | Standard Error 2.4 |
| Usual Care Wait-List | PTSD Symptoms | Baseline | 41.06 score on a scale | Standard Error 3.5 |
| Usual Care Wait-List | PTSD Symptoms | 12 Weeks | 38.19 score on a scale | Standard Error 2.3 |
Comparison: The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for PCL-5 in this sample was 0.38
Secondary
Aerobic Endurance
Aerobic endurance was assessed using the 6-minute walk test (distance).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Patients | Aerobic Endurance | 12 Weeks | 531.1 meters | Standard Error 29.8 |
| Eligible Patients | Aerobic Endurance | Baseline | 462.1 meters | Standard Error 22.3 |
| Usual Care Wait-List | Aerobic Endurance | 12 Weeks | 476.0 meters | Standard Error 21.7 |
| Usual Care Wait-List | Aerobic Endurance | Baseline | 465.9 meters | Standard Error 32 |
Comparison: The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for 6-minute walk in this sample was 0.50