Exercise and PTSD in Older Veterans
|ClinicalTrials.gov Identifier: NCT02295995|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic||Behavioral: Exercise as an Adjuvant Therapy for Veterans with PTSD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise as an Adjuvant Therapy for Veterans With PTSD|
|Actual Study Start Date :||December 18, 2015|
|Actual Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Physical Activity
Participants randomized to this arm will be enrolled in a 12-week physical activity program.
Behavioral: Exercise 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.
No Intervention: Usual Care Wait-List
Participants randomized to this arm will continue 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 [ Time Frame: 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 [ Time Frame: Baseline and 12 Weeks ]Activity levels will be measured using both self-report (questionnaire and activity/attendance logs) and objective methods (activity monitor).
- PTSD Symptoms [ Time Frame: Baseline and 12 Weeks ]PTSD symptom severity will be assessed at both baseline and 12 Weeks (CAPS, PCL Checklist).
- Physical Function [ Time Frame: Baseline and 12 Weeks ]Self-reported function (SF-12) and objective physical performance will be assessed (aerobic endurance, lower and upper body strength, mobility).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295995
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Katherine Shepherd Hall, PhD||Durham VA Medical Center, Durham, NC|