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LoveYourBrain Yoga for Multiple Sclerosis

4 februari 2020 uppdaterad av: Andrew D. Smith III, Dartmouth-Hitchcock Medical Center

The Acceptability, Feasibility, and Impact of a Group-based Yoga and Psychoeducation Program for Community-dwelling Adults With Multiple Sclerosis: A Randomized, Cross-over Pilot Study

The purpose of the study is to assess the feasibility of a 6-week yoga and meditation intervention for people with multiple sclerosis (MS). The study will evaluate the impact of the program on fatigue, anxiety, depression, positive affect, and other measures. A sub-study will collect brain images using MRI on 2 subjects before and after the intervention to identify potential biological markers of MS related-fatigue.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study will recruit 20 subjects with multiple sclerosis (MS) to participate in a 6-week yoga/meditation program. Subjects will be randomly assigned to one of two groups. The first group will complete the yoga/meditation classes, followed by a waiting period. The second group will go through a waiting period, followed by yoga/meditation classes. Two subjects assigned to classes during the first session will be selected to participate in an MRI sub-study to look for biomarkers of MS-associated fatigue. All subjects will complete questionnaires and assessments during 3 clinic visits - at baseline, in between the class sessions, and at the end of the study. Questionnaires will also be mailed to subjects 6 weeks after the last study visit.

Studietyp

Interventionell

Inskrivning (Faktisk)

15

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
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03756
        • Dartmouth-Hitchcock Medical Center

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:

  1. Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
  2. 18 years of age or older
  3. Ability to ambulate without assistance from a device or person
  4. Subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline
  5. Able to read, write, and speak English
  6. Willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment
  7. Willing and able to give informed consent

Exclusion Criteria:

  1. Participation in yoga and/or meditation more than twice within 8 weeks prior to baseline.
  2. MS symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study.
  3. Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study.
  4. Contraindication to scanning, including but not limited to ferromagnetic metal in the body, claustrophobia, inability to lie still or otherwise tolerate being in the scanner.
  5. Pregnant women must be excluded from the imaging component of the study due to unknown but possible risk of fetal exposure to the scanner. Women of child-bearing potential will take a confidential pregnancy test immediately prior to each scan session.

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/meditation
A 6-week yoga/meditation intervention.
Beteende: Yoga/meditation
A 6-week yoga and meditation program with psychoeducation components, delivered through community-based yoga sessions. This program offers structured instruction: 10 minutes of breathing exercises to calm the nervous system, 45 minutes of gentle yoga to improve strength, flexibility, and balance, 15 minutes of guided meditation to enhance attention control, emotional regulation, and self-efficacy, and 20 minutes of facilitated discussion with psychoeducation to build community connection and skills in resilience.
Inget ingripande: Wait list
A wait list control period.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of conducting a yoga intervention study
Tidsram: At the clinic visit immediately following the yoga class session
The feasibility will be determined by the completion rates of the intervention. If fewer than 50% of subjects complete the intervention, it will be deemed unfeasible in the current format.
At the clinic visit immediately following the yoga class session

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in subject self-rated fatigue
Tidsram: Through study completion, approximately 22 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale for MS: 8-item measure of fatigue. Scale range 8 to 40. A lower score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject self-rated self-efficacy
Tidsram: Through study completion, approximately 22 weeks
Liverpool Self-efficacy scale: 17-item measure of self-efficacy. Scale range 17 to 68. A higher score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject self-rated anxiety
Tidsram: Through study completion, approximately 22 weeks
Neuro-Quality of Life (QOL) v1.0 Anxiety - Short Form: 8-item measure of anxiety. Scale range 8 to 40. A lower score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject self-rated depression
Tidsram: Through study completion, approximately 22 weeks
Neuro-Quality of Life (QOL) v1.0 Depression - Short Form: 8-item measure of depression. Scale range 8 to 40. A lower score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject self-rated positive affect
Tidsram: Through study completion, approximately 22 weeks
Neuro-Quality of Life (QOL) v1.0 Positive affect and well-being - Short form: 9-item measure of positive affect and well-being. Scale range 8 to 48. A higher score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject cognition/processing speed
Tidsram: Through study completion, approximately 22 weeks
Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject self-rated sleep disturbance
Tidsram: Through study completion, approximately 22 weeks
Neuro-QOL v1.0 Sleep disturbance - Short Form: 8-item measure of sleep disturbance. Scale range 8 to 40. A lower score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject self-rated pain interference
Tidsram: Through study completion, approximately 22 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) v1.0 Pain Interference - Short Form 6b: 6-item measure of sleep disturbance. Scale range 6 to 30. A lower score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject self-rated quality of life
Tidsram: Through study completion, approximately 22 weeks
Multiple Sclerosis Impact Scale (MSIS-29): 29-item measure of quality of life. Scale range 29 to 145. A lower score represents a better outcome.
Through study completion, approximately 22 weeks
Change in subject self-rated cognitive function
Tidsram: Through study completion, approximately 22 weeks
Neuro-Quality of Life (QOL) v2.0 Cognitive Function - Short Form: 8-item measure of cognitive function. Scale range 8 to 48. A higher score represents a better outcome.
Through study completion, approximately 22 weeks
Satisfaction rating of 6-week yoga program on a scale of 1 - 10
Tidsram: At the clinic visit immediately following the yoga/meditation class session
Satisfaction scale: Subjects will rate their satisfaction with the yoga program on a scale of 1 - 10. Higher scores indicate a better rating.
At the clinic visit immediately following the yoga/meditation class session

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Dartmouth-Hitchcock Medical Center

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 juli 2019

Primärt slutförande (Faktisk)

30 december 2019

Avslutad studie (Faktisk)

30 december 2019

Studieregistreringsdatum

Först inskickad

23 januari 2019

Först inskickad som uppfyllde QC-kriterierna

30 januari 2019

Första postat (Faktisk)

4 februari 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 februari 2020

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D19058

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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