Exercise and PTSD in Older Veterans

Post-traumatic Clinical Trial

Official title:

Exercise as an Adjuvant Therapy for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295995
• Other study ID #: D1316-W
• Secondary ID: 5IK2RX001316-021
• Status: Completed
• Phase: N/A
• Start date: December 18, 2015
• Est. completion date: April 15, 2019

Study information

• Verified date: January 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 15, 2019
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. 2019 Jul 1. doi: 10.1007/s10865-019-00073-w. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline
Primary	Physical Activity	Activity levels (metabolic equivalent [MET]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire.	Baseline and 12 Weeks
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.	Baseline and 12 Weeks
Secondary	Aerobic Endurance	Aerobic endurance was assessed using the 6-minute walk test (distance).	Baseline and 12 Weeks

External Links

•   Click here for more information about this study: Exercise as an Adjuvant Therapy for Veterans with PTSD