LoveYourBrain Yoga for Multiple Sclerosis
2020년 2월 4일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
15
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Dartmouth-Hitchcock Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
- 18 years of age or older
- Ability to ambulate without assistance from a device or person
- Subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline
- Able to read, write, and speak English
- Willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment
- Willing and able to give informed consent
Exclusion Criteria:
- Participation in yoga and/or meditation more than twice within 8 weeks prior to baseline.
- MS symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study.
- Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study.
- 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.
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Yoga/meditation
A 6-week yoga/meditation intervention.
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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.
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간섭 없음: Wait list
A wait list control period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of conducting a yoga intervention study
기간: At the clinic visit immediately following the yoga class session
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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.
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At the clinic visit immediately following the yoga class session
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in subject self-rated fatigue
기간: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Change in subject self-rated self-efficacy
기간: Through study completion, approximately 22 weeks
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Liverpool Self-efficacy scale: 17-item measure of self-efficacy.
Scale range 17 to 68.
A higher score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated anxiety
기간: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Change in subject self-rated depression
기간: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Change in subject self-rated positive affect
기간: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Change in subject cognition/processing speed
기간: Through study completion, approximately 22 weeks
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Single Digit Modalities Test: Measure of cognition/processing speed.
Score range 0 to 110.
A higher score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated sleep disturbance
기간: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Change in subject self-rated pain interference
기간: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Change in subject self-rated quality of life
기간: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Change in subject self-rated cognitive function
기간: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Satisfaction rating of 6-week yoga program on a scale of 1 - 10
기간: At the clinic visit immediately following the yoga/meditation class session
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Satisfaction scale: Subjects will rate their satisfaction with the yoga program on a scale of 1 - 10. Higher scores indicate a better rating.
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At the clinic visit immediately following the yoga/meditation class session
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 7월 1일
기본 완료 (실제)
2019년 12월 30일
연구 완료 (실제)
2019년 12월 30일
연구 등록 날짜
최초 제출
2019년 1월 23일
QC 기준을 충족하는 최초 제출
2019년 1월 30일
처음 게시됨 (실제)
2019년 2월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 2월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 2월 4일
마지막으로 확인됨
2020년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .