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| ID | Type | Description | Link |
|---|---|---|---|
| 5IK2RX001316-02 | U.S. NIH Grant/Contract | View source | |
| 1IK2RX001316-01A2 | U.S. NIH Grant/Contract | View source |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity | Experimental | Participants randomized to this arm will be enrolled in a 12-week physical activity program. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic Endurance | Aerobic endurance was assessed using the 6-minute walk test (distance). | Baseline and 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Shepherd Hall, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29632895 | Background | 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. | |
| 31057332 | Result | Pebole MM, Hall KS. Physical activity promotion in women with PTSD: What we need for progress. Psychol Sport Exerc. 2019 Mar;41:127-129. |
| Label | URL |
|---|---|
| Click here for more information about this study: Exercise as an Adjuvant Therapy for Veterans with PTSD | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | Participants randomized to this arm were enrolled in a 12-week, supervised exercise program. |
| FG001 | Usual Care Wait-List | Participants randomized to this arm continued 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | Participants randomized to this arm were enrolled in a 12-week, supervised exercise program. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | Baseline |
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Adverse Event data were collected for 12 weeks (the duration of the intervention period).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | Participants randomized to this arm were enrolled in a 12-week, supervised exercise program. 36 patients were randomized, of which 31 completed the intervention (included in analyses). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine S. Hall | Durham VA HCS | 919-286-0411 | 6734 | katherine.hall@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2019 | Dec 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 31264055 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| PTSD Checklist DSM-V (PTSD symptoms) | This scale measures PTSD symptoms. Total scale range from 0 to 80, with higher scores indicating more severe PTSD symptoms | Mean | Standard Deviation | units on a scale |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Units | Counts |
|---|
| Participants |
|
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| Primary | Physical Activity | Activity levels (metabolic equivalent [MET]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire. | Posted | Mean | Standard Error | metabolic equivalent (MET)-min/week | Baseline and 12 Weeks |
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| 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. | Posted | Mean | Standard Error | score on a scale | Baseline and 12 Weeks |
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| Secondary | Aerobic Endurance | Aerobic endurance was assessed using the 6-minute walk test (distance). | 2 participants in the usual care (UC) condition did not complete this test at 12 weeks, and were not included in this analysis. | Posted | Mean | Standard Error | meters | Baseline and 12 Weeks |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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 patients were randomized, of which 17 completed the study (included in analyses). | 0 | 17 | 0 | 17 | 0 | 17 |
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