FibromyalgiaPOYSENCT01797263
Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
A study testing Yoga and Structured Exercise in people with Fibromyalgia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Yoga and Structured Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe medical conditions in which exercise is contraindicated (such as significant cardiovascular disease, COPD or asthma needing home oxygen, stroke or TIA in last 6 months, cancer (other than skin cancer) and receiving treatment for it
- Active psychosis
- Hospitalized for psychiatric reasons within the last 6 months
- Active suicidal ideation
- Moderate to severe cognitive impairment
- Involvement in ongoing yoga classes or moderately intense exercise program in the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Yoga, Structured Exercise
- Keywords
- fibromyalgia, yoga, exercise, pain
- Medical subject headings
- Fibromyalgia, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
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.
Structured ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | 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. Receives: Other: Yoga |
| Structured Exercise | Active comparator | 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. Receives: Other: Structured Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
Secondary outcomes (13)
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.
Measured: 3 Month
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.
Measured: 3 Month
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
Measured: 3 Month
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.
Measured: 3 month
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.
Measured: 3 Month
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
Measured: 3 Month
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.
Measured: 3 Month
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.
Measured: 3 Month
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.
Measured: 3 Month
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.
Measured: 3 Month
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.
Measured: 3 Month
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.
Measured: 3 Month
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.
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study start1 Aug 2013
- Primary completion2 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew J. Bair, MD MS, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797263
- Sponsor's protocol ID
- D1100-R
- Acronym
- POYSE
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2013
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allsop VL, Schmid AA, Miller KK, Slaven JE, Daggy JK, Froman A, Kline M, Sargent C, French DD, Ang D, Van Puymbroeck M, Schalk NL, Bair MJ. The Pain Outcomes Comparing Yoga vs. Structured Exercise (POYSE) Trial in Veterans With Fibromyalgia: Study Design and Methods. Front Pain Res (Lausanne). 2022 Jul 7;3:934689. doi: 10.3389/fpain.2022.934689. eCollection 2022.
PubMed 35875477
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
- ClinicalTrials.gov ID
- NCT01797263
- Acronym / sponsor ID
- POYSE / D1100-R
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, yoga, exercise, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: YogaA 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. |
| Structured Exercise | Active comparator | Other: Structured ExerciseA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Severe medical conditions in which exercise is contraindicated (such as significant cardiovascular disease, COPD or asthma needing home oxygen, stroke or TIA in last 6 months, cancer (other than skin cancer) and receiving treatment for it
- Active psychosis
- Hospitalized for psychiatric reasons within the last 6 months
- Active suicidal ideation
- Moderate to severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaA 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. | Other | Yoga |
| Structured ExerciseA 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. | Other | Structured Exercise |
Primary outcome
Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
Time frame: 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.
13 secondary outcomes
Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale
Time frame: 3 Month
Fibromyalgia Impact Questionnaire-Revised Impact Subscale
Time frame: 3 Month
Fibromyalgia Impact Questionnaire Revised Symptoms Subscale
Time frame: 3 Month
Brief Pain Inventory (BPI) Severity Subscale
Time frame: 3 month
PHQ-9 for Depression
Time frame: 3 Month
GAD-7 Anxiety Scale
Time frame: 3 Month
PTSD Checklist of Symptoms
Time frame: 3 Month
SF-12 Physical Score (Health-related Quality of Life)
Time frame: 3 Month
SF-12 Mental Score (Health-related Quality of Life)
Time frame: 3 Month
Multi-dimensional Fatigue Inventory
Time frame: 3 Month
MOS Sleep Scale - Problems Index
Time frame: 3 Month
Pain Catastrophizing Scale
Time frame: 3 Month
Arthritis Self-efficacy Scale
Time frame: 3 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35875477Allsop VL, Schmid AA, Miller KK, Slaven JE, Daggy JK, Froman A, Kline M, Sargent C, French DD, Ang D, Van Puymbroeck M, Schalk NL, Bair MJ. The Pain Outcomes Comparing Yoga vs. Structured Exercise (POYSE) Trial in Veterans With Fibromyalgia: Study Design and Methods. Front Pain Res (Lausanne). 2022 Jul 7;3:934689. doi: 10.3389/fpain.2022.934689. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J. Bair, MD MS principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Structured Exercise in people with Fibromyalgia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.