NCT01797263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 24, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

4.9 years

First QC Date

February 20, 2013

Results QC Date

February 10, 2020

Last Update Submit

February 10, 2020

Conditions

Fibromyalgia

Keywords

fibromyalgiayogaexercisepain

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 month

Secondary Outcomes (13)

  • Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale

    3 Month

  • Fibromyalgia Impact Questionnaire-Revised Impact Subscale

    3 Month

  • Fibromyalgia Impact Questionnaire Revised Symptoms Subscale

    3 Month

  • Brief Pain Inventory (BPI) Severity Subscale

    3 month

  • PHQ-9 for Depression

    3 Month

  • +8 more secondary outcomes

Study Arms (2)

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.

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.

Other: Structured Exercise

Interventions

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.

Yoga
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.

Structured Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (1)

  • 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.

    PMID: 35875477DERIVED

MeSH Terms

Conditions

FibromyalgiaMotor ActivityPain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Limitations and Caveats

Higher than expected study withdrawal

Results Point of Contact

Title
Dr. Matthew J. Bair
Organization
VA Center for Health Information and Communication
mbair@iupui.edu; matthew.bair@va.gov
317-988-2058

Study Officials

  • Matthew J. Bair, MD MS

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

August 1, 2013

Primary Completion

July 2, 2018

Study Completion

December 31, 2018

Last Updated

February 24, 2020

Results First Posted

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)