Fibromyalgia
Conditions
Keywords
fibromyalgia, yoga, exercise, pain
Brief summary
The Pain Outcomes comparing Yoga versus Structured Exercise (POYSE) Trial is a 2-arm parallel group, randomized clinical trial to compare the effectiveness of a yoga-based intervention (YOGA) with that of a structured exercise program (SEP) for subjects with fibromyalgia. The study aims are: 1) to compare the interventions' (YOGA vs. SEP) effects on overall fibromyalgia severity at 1 month (early response), 3 months (immediate post-intervention) and at 6 and 9 months (sustained effects); 2) to compare the interventions effects on specific fibromyalgia symptoms (pain, sleep, and fatigue), functional impairment, and related outcomes (quality of life, psychological symptoms); and 3) to compare the cost-effectiveness of the interventions.
Detailed description
This study sample will include 306 Veterans with fibromyalgia. Patients will be randomized to one of two treatment arms. The YOGA arm will involve a standardized 12-week, yoga-based intervention. The yoga intervention will consist of three treatment components: 1) in-person group yoga taught by a certified yoga therapist; 2) a relaxation audio recording for home-use; and 3) a DVD recording to reinforce concepts taught during in-person yoga sessions. Patients randomized to the structured exercise program (SEP) arm will participate in a 12-week exercise program delivered in a group/class format and supervised by a fitness instructor. In addition, SEP patients will receive a DVD (for home use) describing the benefits of aerobic exercise for fibromyalgia, a one-on-one consultation session with the fitness instructor, an individualized exercise prescription, and supervised exercise sessions for 12 weeks.
Interventions
OTHERYoga
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. It will include low intensity, low impact modified poses adapted with pathophysiologic changes of fibromyalgia in mind. 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.
OTHERStructured 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Veterans will be eligible if they have: * Widespread Pain Index (WPI) greater than 7 and Symptom Severity Scale (SS) greater than 5 or WPI 3-6 and SS greater than 9. * Symptoms have been present at a similar level for at least 3 months * The subject does not have a disorder that would otherwise explain the pain * Moderate pain severity (pain severity score greater than 5) * No changes in fibromyalgia medications for last 4 weeks * Access to a working telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score | 3 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale | 3 Month | This represents a subscale of the FIQr and measures patient perceived difficulty related to fibromyalgia. Min:0, Max: 20. Higher Score = Worse Outcome. |
| Fibromyalgia Impact Questionnaire-Revised Impact Subscale | 3 Month | This is a subscale of the FIQr and measures the overall impact of fibromyalgia symptoms. Min:0, Max: 100. Higher Score = Worse Outcome. |
| Fibromyalgia Impact Questionnaire Revised Symptoms Subscale | 3 Month | This subscale of the FIQr provides an overall fibromyalgia symptom score. Min:0, Max: 100. Higher Score = Worse Outcome |
| Brief Pain Inventory (BPI) Severity Subscale | 3 month | is 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. |
| PHQ-9 for Depression | 3 Month | 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. |
| GAD-7 Anxiety Scale | 3 Month | 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 |
| PTSD Checklist of Symptoms | 3 Month | 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. |
| SF-12 Mental Score (Health-related Quality of Life) | 3 Month | 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. |
| Multi-dimensional Fatigue Inventory | 3 Month | This scale assesses overall fatigue and has been well-validated and used in other fibromyalgia trials. Min:0, Max: 100. Higher Score = Worse Outcome. |
| MOS Sleep Scale - Problems Index | 3 Month | 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. |
| Pain Catastrophizing Scale | 3 Month | 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. |
| Arthritis Self-efficacy Scale | 3 Month | 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. |
| SF-12 Physical Score (Health-related Quality of Life) | 3 Month | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 129 |
| 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. | 127 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 15 | 15 |
| Overall Study | Withdrawal by Subject | 21 | 25 |
Baseline characteristics
| Characteristic | Yoga | Total | Structured Exercise |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 10.8 | 57.2 years STANDARD_DEVIATION 10.9 | 56.4 years STANDARD_DEVIATION 11 |
| Arthritis self-efficacy scale | 33.4 units on a scale STANDARD_DEVIATION 12.5 | 33.3 units on a scale STANDARD_DEVIATION 12.8 | 33.3 units on a scale STANDARD_DEVIATION 13.2 |
| Brief Pain Inventory Pain Severity | 6.6 units on a scale STANDARD_DEVIATION 1.6 | 6.7 units on a scale STANDARD_DEVIATION 1.6 | 6.8 units on a scale STANDARD_DEVIATION 1.6 |
| Employment Status Employed | 43 Participants | 83 Participants | 40 Participants |
| Employment Status Other | 7 Participants | 23 Participants | 16 Participants |
| Employment Status Retired | 43 Participants | 81 Participants | 38 Participants |
| Employment Status Unable to work | 36 Participants | 69 Participants | 33 Participants |
| Fibromyalgia Impact Questionnaire-Revised Difficulty subscale | 12.7 units on a scale STANDARD_DEVIATION 6.8 | 12.7 units on a scale STANDARD_DEVIATION 6.6 | 12.7 units on a scale STANDARD_DEVIATION 6.5 |
| Fibromyalgia Impact Questionnaire-Revised Impact subscale | 10.2 units on a scale STANDARD_DEVIATION 6.1 | 10.0 units on a scale STANDARD_DEVIATION 5.9 | 9.8 units on a scale STANDARD_DEVIATION 5.8 |
| Fibromyalgia Impact Questionnaire Revised Symptoms subscale | 28.1 units on a scale STANDARD_DEVIATION 7.4 | 27.9 units on a scale STANDARD_DEVIATION 7.8 | 27.7 units on a scale STANDARD_DEVIATION 8.1 |
| Fibromyalgia Impact Questionnaire-Revised Total | 51.0 units on a scale STANDARD_DEVIATION 17.4 | 50.4 units on a scale STANDARD_DEVIATION 17.4 | 50.1 units on a scale STANDARD_DEVIATION 17.5 |
| GAD-7 Anxiety Scale | 8.0 units on a scale STANDARD_DEVIATION 5.9 | 7.9 units on a scale STANDARD_DEVIATION 5.6 | 7.7 units on a scale STANDARD_DEVIATION 5.3 |
| Income comfort level Comfortable | 60 Participants | 117 Participants | 57 Participants |
| Income comfort level Just enough | 47 Participants | 93 Participants | 46 Participants |
| Income comfort level Not enough | 19 Participants | 42 Participants | 23 Participants |
| Income comfort level Refused to answer/missing | 3 Participants | 4 Participants | 1 Participants |
| Marital Status Divorced/separated | 34 Participants | 80 Participants | 46 Participants |
| Marital Status Married/unmarried couple | 76 Participants | 142 Participants | 66 Participants |
| Marital Status Widowed/never married | 19 Participants | 34 Participants | 15 Participants |
| MOS Sleep Scale - problems index | 47.0 units on a scale STANDARD_DEVIATION 11.3 | 46.8 units on a scale STANDARD_DEVIATION 10.2 | 46.5 units on a scale STANDARD_DEVIATION 8.9 |
| Multi-dimensional fatigue inventory | 60.2 units on a scale STANDARD_DEVIATION 22 | 59.6 units on a scale STANDARD_DEVIATION 21.9 | 59.0 units on a scale STANDARD_DEVIATION 21.9 |
| Pain catastrophizing scale | 23.3 units on a scale STANDARD_DEVIATION 13.7 | 23.7 units on a scale STANDARD_DEVIATION 13.4 | 24.0 units on a scale STANDARD_DEVIATION 13.1 |
| Patient Health Questionnaire-9 (PHQ-9) Depression Scale | 11.5 units on a scale STANDARD_DEVIATION 6.2 | 11.5 units on a scale STANDARD_DEVIATION 6.2 | 11.4 units on a scale STANDARD_DEVIATION 6.3 |
| PTSD Checklist of symptoms | 51.5 units on a scale STANDARD_DEVIATION 15.4 | 52.1 units on a scale STANDARD_DEVIATION 14.9 | 52.6 units on a scale STANDARD_DEVIATION 14.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 94 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) White | 68 Participants | 137 Participants | 69 Participants |
| Sex: Female, Male Female | 41 Participants | 80 Participants | 39 Participants |
| Sex: Female, Male Male | 88 Participants | 176 Participants | 88 Participants |
| SF-12 Mental Score (health-related quality of life) | 44.9 units on a scale STANDARD_DEVIATION 9.5 | 44.2 units on a scale STANDARD_DEVIATION 9.5 | 43.7 units on a scale STANDARD_DEVIATION 9.4 |
| SF-12 Physical Score (health-related quality of life) | 23.3 units on a scale STANDARD_DEVIATION 13.7 | 23.7 units on a scale STANDARD_DEVIATION 16.2 | 24.0 units on a scale STANDARD_DEVIATION 18.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 129 | 0 / 127 |
| other Total, other adverse events | 26 / 129 | 29 / 127 |
| serious Total, serious adverse events | 2 / 129 | 4 / 127 |
Outcome results
Primary
Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
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.
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score | 41.5 units on a scale | Standard Deviation 19.3 |
| Structured Exercise | Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score | 42.2 units on a scale | Standard Deviation 20.6 |
Secondary
Arthritis Self-efficacy Scale
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.
Time frame: 3 Month
Population: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | Arthritis Self-efficacy Scale | 37.2 units on a scale | Standard Deviation 12.2 |
| Structured Exercise | Arthritis Self-efficacy Scale | 37.0 units on a scale | Standard Deviation 14.4 |
Secondary
Brief Pain Inventory (BPI) Severity Subscale
is 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.
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | Brief Pain Inventory (BPI) Severity Subscale | 5.6 units on a scale | Standard Deviation 1.9 |
| Structured Exercise | Brief Pain Inventory (BPI) Severity Subscale | 5.9 units on a scale | Standard Deviation 2.3 |
Secondary
Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale
This represents a subscale of the FIQr and measures patient perceived difficulty related to fibromyalgia. Min:0, Max: 20. Higher Score = Worse Outcome.
Time frame: 3 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale | 10.8 units on a scale | Standard Deviation 7.2 |
| Structured Exercise | Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale | 10.5 units on a scale | Standard Deviation 6.9 |
Secondary
Fibromyalgia Impact Questionnaire-Revised Impact Subscale
This is a subscale of the FIQr and measures the overall impact of fibromyalgia symptoms. Min:0, Max: 100. Higher Score = Worse Outcome.
Time frame: 3 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | Fibromyalgia Impact Questionnaire-Revised Impact Subscale | 7.3 units on a scale | Standard Deviation 5.7 |
| Structured Exercise | Fibromyalgia Impact Questionnaire-Revised Impact Subscale | 7.9 units on a scale | Standard Deviation 6.2 |
Secondary
Fibromyalgia Impact Questionnaire Revised Symptoms Subscale
This subscale of the FIQr provides an overall fibromyalgia symptom score. Min:0, Max: 100. Higher Score = Worse Outcome
Time frame: 3 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | Fibromyalgia Impact Questionnaire Revised Symptoms Subscale | 23.5 units on a scale | Standard Deviation 8.9 |
| Structured Exercise | Fibromyalgia Impact Questionnaire Revised Symptoms Subscale | 23.8 units on a scale | Standard Deviation 9.7 |
Secondary
GAD-7 Anxiety Scale
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
Time frame: 3 Month
Population: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | GAD-7 Anxiety Scale | 6.5 units on a scale | Standard Deviation 5.7 |
| Structured Exercise | GAD-7 Anxiety Scale | 6.6 units on a scale | Standard Deviation 5.4 |
Secondary
MOS Sleep Scale - Problems Index
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.
Time frame: 3 Month
Population: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | MOS Sleep Scale - Problems Index | 48.5 units on a scale | Standard Deviation 10.4 |
| Structured Exercise | MOS Sleep Scale - Problems Index | 44.8 units on a scale | Standard Deviation 9.6 |
Secondary
Multi-dimensional Fatigue Inventory
This scale assesses overall fatigue and has been well-validated and used in other fibromyalgia trials. Min:0, Max: 100. Higher Score = Worse Outcome.
Time frame: 3 Month
Population: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | Multi-dimensional Fatigue Inventory | 49.2 units on a scale | Standard Deviation 24.6 |
| Structured Exercise | Multi-dimensional Fatigue Inventory | 51.4 units on a scale | Standard Deviation 26.3 |
Secondary
Pain Catastrophizing Scale
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.
Time frame: 3 Month
Population: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | Pain Catastrophizing Scale | 17.8 units on a scale | Standard Deviation 12.7 |
| Structured Exercise | Pain Catastrophizing Scale | 18.6 units on a scale | Standard Deviation 13.9 |
Secondary
PHQ-9 for Depression
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.
Time frame: 3 Month
Population: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | PHQ-9 for Depression | 8.6 units on a scale | Standard Deviation 6.1 |
| Structured Exercise | PHQ-9 for Depression | 9.8 units on a scale | Standard Deviation 6.4 |
Secondary
PTSD Checklist of Symptoms
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.
Time frame: 3 Month
Population: This measure was completed in those participants who screened positive for PTSD
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | PTSD Checklist of Symptoms | 48.3 units on a scale | Standard Deviation 14.7 |
| Structured Exercise | PTSD Checklist of Symptoms | 49.0 units on a scale | Standard Deviation 17.4 |
Secondary
SF-12 Mental Score (Health-related Quality of Life)
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.
Time frame: 3 Month
Population: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | SF-12 Mental Score (Health-related Quality of Life) | 46.4 units on a scale | Standard Deviation 8.8 |
| Structured Exercise | SF-12 Mental Score (Health-related Quality of Life) | 46.4 units on a scale | Standard Deviation 10 |
Secondary
SF-12 Physical Score (Health-related Quality of Life)
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.
Time frame: 3 Month
Population: A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga | SF-12 Physical Score (Health-related Quality of Life) | 17.8 units on a scale | Standard Deviation 12.7 |
| Structured Exercise | SF-12 Physical Score (Health-related Quality of Life) | 18.6 units on a scale | Standard Deviation 13.9 |