Trial Outcomes & Findings for Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial (NCT NCT01797263)
NCT ID: NCT01797263
Last Updated: 2020-02-24
Results Overview
This measure will be assessed at Baseline, 1, 3, 6 and 9 months. The 3 month is the primary end point and the 6 and 9 month assessments are for sustained effect. Min:0, Max: 90. Higher Score = Worse Outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
256 participants
Primary outcome timeframe
3 month
Results posted on
2020-02-24
Participant Flow
Participant milestones
| Measure |
Yoga
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
127
|
|
Overall Study
1 Month
|
96
|
87
|
|
Overall Study
3 Month
|
87
|
84
|
|
Overall Study
6 Month
|
90
|
85
|
|
Overall Study
9 Month
|
92
|
87
|
|
Overall Study
COMPLETED
|
92
|
87
|
|
Overall Study
NOT COMPLETED
|
37
|
40
|
Reasons for withdrawal
| Measure |
Yoga
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
21
|
25
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
15
|
15
|
Baseline Characteristics
Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
Baseline characteristics by cohort
| Measure |
Yoga
n=129 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=127 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital Status
Married/unmarried couple
|
76 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Marital Status
Divorced/separated
|
34 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Marital Status
Widowed/never married
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Employment Status
Employed
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Employment Status
Retired
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Employment Status
Unable to work
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Employment Status
Other
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Income comfort level
Comfortable
|
60 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Income comfort level
Just enough
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Income comfort level
Not enough
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Income comfort level
Refused to answer/missing
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Fibromyalgia Impact Questionnaire-Revised Total
|
51.0 units on a scale
STANDARD_DEVIATION 17.4 • n=5 Participants
|
50.1 units on a scale
STANDARD_DEVIATION 17.5 • n=7 Participants
|
50.4 units on a scale
STANDARD_DEVIATION 17.4 • n=5 Participants
|
|
Fibromyalgia Impact Questionnaire-Revised Difficulty subscale
|
12.7 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
12.7 units on a scale
STANDARD_DEVIATION 6.5 • n=7 Participants
|
12.7 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Fibromyalgia Impact Questionnaire-Revised Impact subscale
|
10.2 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
9.8 units on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Fibromyalgia Impact Questionnaire Revised Symptoms subscale
|
28.1 units on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
27.7 units on a scale
STANDARD_DEVIATION 8.1 • n=7 Participants
|
27.9 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Brief Pain Inventory Pain Severity
|
6.6 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Patient Health Questionnaire-9 (PHQ-9) Depression Scale
|
11.5 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 6.3 • n=7 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
GAD-7 Anxiety Scale
|
8.0 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 5.3 • n=7 Participants
|
7.9 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
PTSD Checklist of symptoms
|
51.5 units on a scale
STANDARD_DEVIATION 15.4 • n=5 Participants
|
52.6 units on a scale
STANDARD_DEVIATION 14.4 • n=7 Participants
|
52.1 units on a scale
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
SF-12 Physical Score (health-related quality of life)
|
23.3 units on a scale
STANDARD_DEVIATION 13.7 • n=5 Participants
|
24.0 units on a scale
STANDARD_DEVIATION 18.6 • n=7 Participants
|
23.7 units on a scale
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
SF-12 Mental Score (health-related quality of life)
|
44.9 units on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
43.7 units on a scale
STANDARD_DEVIATION 9.4 • n=7 Participants
|
44.2 units on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Multi-dimensional fatigue inventory
|
60.2 units on a scale
STANDARD_DEVIATION 22.0 • n=5 Participants
|
59.0 units on a scale
STANDARD_DEVIATION 21.9 • n=7 Participants
|
59.6 units on a scale
STANDARD_DEVIATION 21.9 • n=5 Participants
|
|
MOS Sleep Scale - problems index
|
47.0 units on a scale
STANDARD_DEVIATION 11.3 • n=5 Participants
|
46.5 units on a scale
STANDARD_DEVIATION 8.9 • n=7 Participants
|
46.8 units on a scale
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Pain catastrophizing scale
|
23.3 units on a scale
STANDARD_DEVIATION 13.7 • n=5 Participants
|
24.0 units on a scale
STANDARD_DEVIATION 13.1 • n=7 Participants
|
23.7 units on a scale
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Arthritis self-efficacy scale
|
33.4 units on a scale
STANDARD_DEVIATION 12.5 • n=5 Participants
|
33.3 units on a scale
STANDARD_DEVIATION 13.2 • n=7 Participants
|
33.3 units on a scale
STANDARD_DEVIATION 12.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthThis measure will be assessed at Baseline, 1, 3, 6 and 9 months. The 3 month is the primary end point and the 6 and 9 month assessments are for sustained effect. Min:0, Max: 90. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=87 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
|
41.5 units on a scale
Standard Deviation 19.3
|
42.2 units on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: 3 MonthThis represents a subscale of the FIQr and measures patient perceived difficulty related to fibromyalgia. Min:0, Max: 20. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=87 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale
|
10.8 units on a scale
Standard Deviation 7.2
|
10.5 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 3 MonthThis is a subscale of the FIQr and measures the overall impact of fibromyalgia symptoms. Min:0, Max: 100. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=87 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Fibromyalgia Impact Questionnaire-Revised Impact Subscale
|
7.3 units on a scale
Standard Deviation 5.7
|
7.9 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 3 MonthThis subscale of the FIQr provides an overall fibromyalgia symptom score. Min:0, Max: 100. Higher Score = Worse Outcome
Outcome measures
| Measure |
Yoga
n=87 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Fibromyalgia Impact Questionnaire Revised Symptoms Subscale
|
23.5 units on a scale
Standard Deviation 8.9
|
23.8 units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 3 monthis an 11-item, multidimensional pain measurement tool with demonstrated reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and enjoyment of life.Min:0, Max: 40. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=87 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Brief Pain Inventory (BPI) Severity Subscale
|
5.6 units on a scale
Standard Deviation 1.9
|
5.9 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
will be used to assess depression severity. Several studies have validated the PHQ-9 as a diagnostic measure with excellent psychometric properties. Internal consistency has consistently been shown to be high (Cronbach's alpha \> 0.80) and test-retest assessment showed the PHQ-9 to be a responsive and reliable measure of depression treatment outcomes. Min:0, Max: 27. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=85 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
PHQ-9 for Depression
|
8.6 units on a scale
Standard Deviation 6.1
|
9.8 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
This 7-item scale represent a measure of anxiety symptom severity and provides a score from 0 to 21 with higher scores representing more severe anxiety
Outcome measures
| Measure |
Yoga
n=86 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
GAD-7 Anxiety Scale
|
6.5 units on a scale
Standard Deviation 5.7
|
6.6 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: This measure was completed in those participants who screened "positive" for PTSD
This 17-item scale assess PTSD symptom severity and provides a severity score; with higher scores representing more severe PTSD. Min: 0, Max: 85 with higher scores representing more severity.
Outcome measures
| Measure |
Yoga
n=42 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=46 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
PTSD Checklist of Symptoms
|
48.3 units on a scale
Standard Deviation 14.7
|
49.0 units on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=86 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
SF-12 Physical Score (Health-related Quality of Life)
|
17.8 units on a scale
Standard Deviation 12.7
|
18.6 units on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=86 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
SF-12 Mental Score (Health-related Quality of Life)
|
46.4 units on a scale
Standard Deviation 8.8
|
46.4 units on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
This scale assesses overall fatigue and has been well-validated and used in other fibromyalgia trials. Min:0, Max: 100. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=85 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Multi-dimensional Fatigue Inventory
|
49.2 units on a scale
Standard Deviation 24.6
|
51.4 units on a scale
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
This scale assesses different aspects of sleep quality and provides an overall index with higher scores representing more severe sleep problems. Min:0, Max: 100. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=86 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
MOS Sleep Scale - Problems Index
|
48.5 units on a scale
Standard Deviation 10.4
|
44.8 units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
This 13-item scale assesses pain catastrophizing which has been found to be a predictor of poor treatment response. Min: 0. Max: 52. Higher Score = Worse Outcome.
Outcome measures
| Measure |
Yoga
n=86 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Pain Catastrophizing Scale
|
17.8 units on a scale
Standard Deviation 12.7
|
18.6 units on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
This scale has been well-validated to assess self-efficacy or confidence in a person's ability to complete a task. Min: 0, Max: 60. Higher score represents improvement.
Outcome measures
| Measure |
Yoga
n=86 Participants
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=84 Participants
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Arthritis Self-efficacy Scale
|
37.2 units on a scale
Standard Deviation 12.2
|
37.0 units on a scale
Standard Deviation 14.4
|
Adverse Events
Yoga
Serious events: 2 serious events
Other events: 26 other events
Deaths: 1 deaths
Structured Exercise
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Yoga
n=129 participants at risk
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=127 participants at risk
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/129 • 9 months
|
0.79%
1/127 • Number of events 1 • 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/129 • 9 months
|
0.79%
1/127 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.00%
0/129 • 9 months
|
0.79%
1/127 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Suicidal ideation
|
1.6%
2/129 • Number of events 2 • 9 months
|
0.79%
1/127 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
Yoga
n=129 participants at risk
A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
|
Structured Exercise
n=127 participants at risk
A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
|
|---|---|---|
|
Psychiatric disorders
Thoughts of self-harm
|
20.2%
26/129 • Number of events 35 • 9 months
|
22.8%
29/127 • Number of events 46 • 9 months
|
Additional Information
Dr. Matthew J. Bair
VA Center for Health Information and Communication
Phone: 317-988-2058
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place