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Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial (POYSE)

10 februari 2020 uppdaterad av: VA Office of Research and Development
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

256

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Exclusion Criteria:

Exclusion criteria includes:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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. 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.
Övrig: 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. 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.
Aktiv komparator: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
Tidsram: 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.
3 month

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale
Tidsram: 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.
3 Month
Fibromyalgia Impact Questionnaire-Revised Impact Subscale
Tidsram: 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.
3 Month
Fibromyalgia Impact Questionnaire Revised Symptoms Subscale
Tidsram: 3 Month
This subscale of the FIQr provides an overall fibromyalgia symptom score. Min:0, Max: 100. Higher Score = Worse Outcome
3 Month
Brief Pain Inventory (BPI) Severity Subscale
Tidsram: 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.
3 month
PHQ-9 for Depression
Tidsram: 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.
3 Month
GAD-7 Anxiety Scale
Tidsram: 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
3 Month
PTSD Checklist of Symptoms
Tidsram: 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.
3 Month
SF-12 Physical Score (Health-related Quality of Life)
Tidsram: 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.
3 Month
SF-12 Mental Score (Health-related Quality of Life)
Tidsram: 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.
3 Month
Multi-dimensional Fatigue Inventory
Tidsram: 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.
3 Month
MOS Sleep Scale - Problems Index
Tidsram: 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.
3 Month
Pain Catastrophizing Scale
Tidsram: 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.
3 Month
Arthritis Self-efficacy Scale
Tidsram: 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.
3 Month

Samarbetspartners och utredare

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Sponsor

VA Office of Research and Development

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2013

Primärt slutförande (Faktisk)

2 juli 2018

Avslutad studie (Faktisk)

31 december 2018

Studieregistreringsdatum

Först inskickad

20 februari 2013

Först inskickad som uppfyllde QC-kriterierna

20 februari 2013

Första postat (Uppskatta)

22 februari 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 februari 2020

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D1100-R

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