- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02100020
Implementing Physical Activity Guidelines for Adults With MS
A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.
The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.
This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8S 4K1
- McMaster University, Physical Activity Centre for Excellence
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Kingston, Ontario, 캐나다, K7L 3N6
- Queens University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of MS with mild-moderate disability (EDSS 1-7)
- Aged 18-60
- Medical clearance to participate in physical activity
Exclusion Criteria:
- current participation in regular physical activity (at least twice-weekly)
- other serious medical condition that might impair ability to participate in strength or aerobic exercise
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Direct Referral to Physical Activity
The REF group will be referred to a centre-based community exercise program in their respective community (either the MacWheelers or Revved Up) by a clinical neurologist where they will be prescribed exercise based on the PAGs for adults with MS, and according to their individual capabilities.
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Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.
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간섭 없음: Control
The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adherence to the Physical Activity Guidelines
기간: 3 years
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Adherence to the physical activity guidelines will be analyzed by having participants fill in a weekly physical activity log that will be sent to them by email.
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3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical Fitness
기간: At baseline and after the 16 week intervention
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Peak oxygen uptake, maximum muscle strength, bodyweight
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At baseline and after the 16 week intervention
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Perceived Quality of Life
기간: At baseline and after the 16 week intervention
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Multiple Sclerosis Quality of Life (MSQoL) scale
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At baseline and after the 16 week intervention
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Fatigue
기간: At baseline and after the 16 week intervention
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Multiple Sclerosis Fatigue Impact Scale (MSFIS)
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At baseline and after the 16 week intervention
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Mobility
기간: At baseline and after the 16 week intervention
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25ft walk test
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At baseline and after the 16 week intervention
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Blood markers of cardiovascular disease risk
기간: At baseline and after the 16 week intervention
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blood lipid panel, HbA1c, fasting glucose
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At baseline and after the 16 week intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Audrey L Hicks, Ph.D., McMaster University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MSProject2001
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. .
다발성 경화증에 대한 임상 시험
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Sanko University완전한MULTİPLE SCLEROSİS | BALANCE | 유효성 | 신뢰도터키 (Türkiye)
-
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Direct Referral to physical activity에 대한 임상 시험
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The University of Hong Kong모병
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Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)완전한
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Centre de Recherche de l'Institut Universitaire...Canadian Institutes of Health Research (CIHR)완전한