Clinical trial NCT02295995: Exercise and PTSD in Older Veterans
Official title: Exercise as an Adjuvant Therapy for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic
Keywords: Aged
Exercise
Veterans
Adherence
Clinical Trials, Randomized
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-11-20
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Patient Recruitment
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline and 12 Weeks
measure: PTSD Symptoms
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
measure: Aerobic Endurance
timeFrame: Baseline and 12 Weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Katherine Shepherd Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall KS, Morey MC, Beckham JC, Bosworth HB, Pebole MM, Pieper CF, Sloane R. The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. Transl J Am Coll Sports Med. 2018 Mar 15;3(6):43-51. doi: 10.1249/TJX.0000000000000056.
citation: Pebole MM, Hall KS. Physical activity promotion in women with PTSD: What we need for progress. Psychol Sport Exerc. 2019 Mar;41:127-129.
citation: Hall KS, Morey MC, Bosworth HB, Beckham JC, Pebole MM, Sloane R, Pieper CF. Pilot randomized controlled trial of exercise training for older veterans with PTSD. J Behav Med. 2020 Aug;43(4):648-659. doi: 10.1007/s10865-019-00073-w. Epub 2019 Jul 1.