Trial Outcomes & Findings for Improving Mind/Body Health and Functioning With Integrative Exercise (NCT NCT02856412)

Last Updated: 2024-09-19

Results Overview

The CAPS-5 is a 20 item scale that provides both a dimensional and categorical measure of PTSD. The CAPS-5 items are rated with a single severity score, ranging from 0-80 with higher scores indicating worse severity, that incorporates both frequency and intensity PTSD-related symptoms. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization).

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Veterans Group Exercise Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
Overall Study STARTED	41	43
Overall Study COMPLETED	30	34
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Mind/Body Health and Functioning With Integrative Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	26 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
Clinician Administered PTSD Scale (CAPS) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Illness Management and Recovery	24.4 units on a scale Standard Deviation 11.1	22.0 units on a scale Standard Deviation 11.3

PRIMARY outcome

Timeframe: 12 weeks

The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original WHOQOL-100 instrument and is more convenient for use in large research studies or clinical trials. The Psychological Domain, the investigators' primary outcome, is derived from 6 items which index body image, negative \& positive feelings, self-esteem, spirituality, and cognition. Each of the 6 items have 5 response options with higher scores indicating higher psychological health. The mean score of items within each domain is used to calculate the domain score. The domain score is then linearly transformed to scale of 0-100 to enable comparisons between other domains composed of unequal numbers of items. (Skevington et al. Quality of Life Research 13: 299-310, 2004.)

Outcome measures

Outcome measures
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
The World Health Organization Quality of Life (WHOQOL-BREF) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Monitor Only	41.5 units on a scale Standard Deviation 19.4	45.2 units on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: 12 weeks

The FFMQ is a 39-item questionnaire derived from a factor analysis of other mindfulness questionnaires. It assesses five facets of mindfulness: observing, describing, acting with awareness, non-judging and non-reactivity to inner experience which represent elements of mindfulness as it is currently conceptualized. Items are rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Scale range is 39-195 with higher scores indicating higher mindfulness. Score ranges for five facets are: observing (8-40; describing (8-40), acting with awareness (8-40), non-judging (8-40), and nonreactivity to inner experience (7-35).

Outcome measures

Outcome measures
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
Five Facet Mindfulness Questionnaire (FFMQ)- Observing	22.2 score on a scale Standard Deviation 11.4	26.4 score on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: 12 weeks

The Godin Leisure-Time Exercise Questionnaire is a validated brief inventory assessing sedentary, work, recreational, and aerobic activity in a typical week. The overall score is between zero and 119, and higher GLTEQ scores demonstrate more physical activity.

Outcome measures

Outcome measures
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
Godin Leisure-Time Exercise Questionnaire	44.2 score on a scale Standard Deviation 40.2	43.8 score on a scale Standard Deviation 36.0

SECONDARY outcome

Timeframe: 12 weeks

The PCL-5 is a validated self-report rating scale for assessing PTSD symptoms. It consists of 20 items that correspond to the DSM-5 symptoms of PTSD. The range is 0-80 with higher scores indicating worse severity.

Outcome measures

Outcome measures
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
PTSD Checklist for DSM-5 (PCL-5)	36.3 score on a scale Standard Deviation 17.5	39.9 score on a scale Standard Deviation 15.7

SECONDARY outcome

Timeframe: 12 weeks

The SCL-90-R is a standard self-report measure of general psychopathology. Each item on the SCL-90-R is graded on a five-point scale from 0 (not at all) to 4 (extremely).The Global Severity Index (GSI) is the average score for all the items and ranges from 0-4 with higher scores indexes greater psychopathology.

Outcome measures

Outcome measures
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
Symptom Check-List-90-Revised (SCL-90-R)	1.14 score on a scale Standard Deviation 0.68	1.13 score on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: 12 weeks

This self-report measure provides a subjective assessment of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances (including nightmares), use of sedative-hypnotics, and daytime energy. The PSQI global score range is 0-21 with higher scores indicating worse sleep quality.

Outcome measures

Outcome measures
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
Pittsburgh Sleep Quality Index (PSQI)	11.4 score on a scale Standard Deviation 5.2	10.7 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 12 weeks

The ISI is a self-report measure that is a more specific index of perceived insomnia severity, as compared to the widely used PSQI measure which captures sleep disturbances of all types. The ISI uses a 5-point Likert scale to rate the severity of insomnia symptoms. The total score ranges from 0-28 with higher scores indicating worse insomnia severity.

Outcome measures

Outcome measures
Measure	Veterans Group Exercise n=41 Participants Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises. Veterans Group Exercise (VGX): Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.	Illness Management and Recovery n=43 Participants Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
Insomnia Severity Index (ISI)	13.6 score on a scale Standard Deviation 6.8	13.2 score on a scale Standard Deviation 5.4

Adverse Events

Veterans Group Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Illness Management and Recovery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Neylan, MD

San Francisco Veterans Health Care System

Phone: 415-750-6961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place