Exercise and PTSD in Older Veterans

NCT02295995 | Completed Results

• 3 other identifiers: D1316-W5IK2RX001316-021IK2RX001316-01A2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-traumatic

Keywords

Aged; Exercise; Veterans; Adherence; Clinical Trials, Randomized

Outcome Measures

Primary Outcomes (3)

• 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

• Physical Activity

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

  Baseline and 12 Weeks

• 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 Outcomes (1)

• Aerobic Endurance

  Baseline and 12 Weeks

Study Arms (2)

Physical Activity

EXPERIMENTAL

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

Usual Care Wait-List

NO INTERVENTION

Participants randomized to this arm will continue 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.

Interventions

Exercise as an Adjuvant Therapy for Veterans with PTSD BEHAVIORAL

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.

Physical Activity

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related 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.

  PMID: 29632895 BACKGROUND

• Pebole MM, Hall KS. Physical activity promotion in women with PTSD: What we need for progress. Psychol Sport Exerc. 2019 Mar;41:127-129.

  PMID: 31057332 RESULT

• 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.

  PMID: 31264055 RESULT

Related Links

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

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The recruitment period started November 2015 and was originally planned to last 18 months, but was extended to 2 years due to various life events of the PI that caused delays in recruitment.

Results Point of Contact

• Title: Dr. Katherine S. Hall
• Organization: Durham VA HCS

katherine.hall@duke.edu

919-286-0411

Study Officials

• Katherine Shepherd Hall, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 20, 2014
• Study Start: December 18, 2015
• Primary Completion: May 8, 2018
• Study Completion: April 15, 2019
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)