Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

LoveYourBrain Yoga for Multiple Sclerosis

4. Februar 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

15

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New Hampshire
      • Lebanon, New Hampshire, Vereinigte Staaten, 03756
        • Dartmouth-Hitchcock Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Yoga/meditation
A 6-week yoga/meditation intervention.
Verhalten: 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.
Kein Eingriff: Wait list
A wait list control period.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility of conducting a yoga intervention study
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in subject self-rated fatigue
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Dartmouth-Hitchcock Medical Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2019

Primärer Abschluss (Tatsächlich)

30. Dezember 2019

Studienabschluss (Tatsächlich)

30. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

23. Januar 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Januar 2019

Zuerst gepostet (Tatsächlich)

4. Februar 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Februar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Februar 2020

Zuletzt verifiziert

1. Februar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D19058

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Yoga/meditation

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Dominican Republic

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren