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

10 febbraio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

256

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Comparatore attivo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

VA Office of Research and Development

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2013

Completamento primario (Effettivo)

2 luglio 2018

Completamento dello studio (Effettivo)

31 dicembre 2018

Date di iscrizione allo studio

Primo inviato

20 febbraio 2013

Primo inviato che soddisfa i criteri di controllo qualità

20 febbraio 2013

Primo Inserito (Stima)

22 febbraio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 febbraio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 febbraio 2020

Ultimo verificato

1 febbraio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D1100-R

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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