Exercise and Brain Health in MS
Exercise and Brain Health in Multiple Sclerosis: A Pilot Study
연구 개요
상세 설명
Multiple Sclerosis (MS) is a chronic, degenerative disease of the central nervous system, characterized by inflammatory demyelination and axonal degeneration. MS affects approximately 1 in 500 Canadians. There is no cure for MS and the heterogeneous symptoms of the disease makes it difficult to prescribe effective treatment strategies for disease management. While the progression, severity and specific symptom profile vary from person to person, there are three key symptoms associated with brain health- fatigue, depression and cognitive impairment- that invariably lead to poor quality of life and increased health care costs. Unfortunately, the majority of people with MS suffer from these symptoms (fatigue affects ~90%, depression affects ~50% and cognitive impairment affects 40-65%) and a critical challenge with MS is that these symptoms do not present individually. For example, persons with MS who experience depression are more likely to also experience fatigue and/or cognitive impairment, which together may be more detrimental to quality of life than each symptom alone.
New evidence suggests that the three symptoms affecting brain health may be interrelated through a common mechanism of inflammation. Further, physical exercise is known to reduce inflammation and thus is a prime candidate for a novel therapeutic approach to symptom management through its effect on modulating the inflammatory response. Indeed, physical activity is already used to improve the physical status of individuals with MS and evidence-based physical activity guidelines (PAGs) for MS have been developed to guide prescription. However, the guidelines have not been tested for their effects on reducing inflammation and brain health disease systems. Therefore, the proposed research will be the first to evaluate the clinical utility of the PAGs for MS in reducing brain health disease symptoms and improving quality of life, and the first to comprehensively determine the putative effects of inflammation on these symptoms.
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
- Physical Activity Centre for Excellence
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of Relapsing-Remitting MS (RRMS) with mild-moderate disability (EDSS 2-5)
- Aged 18-60
- Score of ≥ 10 on MFIS-5*
- Medical clearance to participate in physical activity * The MFIS-5 is an abbreviated version of the 21-item MFIS, consisting of 5 of the 21 items of the MFIS that most strongly correlate with the total MFIS score. A score ≥ 10 on the MFIS-5 is considered to indicate "high-level" of fatigue
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: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Exercise
Participants will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS for 12 weeks at McMaster University.
Following this, they will return to their normal daily activities for a further 12 weeks.
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An individualized exercise plan, incorporating aerobic and resistance exercises, following the Physical Activity Guideline recommendations will be provided for each participant.
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실험적: Wait-list Control
Participants will engage in their usual daily activities for the first 12 weeks of the study, then will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS at McMaster University for the 2nd 12 weeks.
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An individualized exercise plan, incorporating aerobic and resistance exercises, following the Physical Activity Guideline recommendations will be provided for each participant.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Perceived Fatigue
기간: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
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Changes in perceived fatigue as a result of the intervention will be assessed through changes in scores on the Modified Fatigue Impact Scale (MFIS-21).
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Outcome will be measured at Baseline, 12 weeks and 24 weeks.
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Change in Inflammatory Markers
기간: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
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Inflammatory markers will be measured from the blood.
Participants will have 15ml of blood drawn by a trained phlebotomist.
Levels of serum cytokines (TNF, IL6, IL10, IL1RA) will be measured in using the custom created Milliplex MAP Human Magnetic Bead Panel (Millipore, ON, CA).
Cellular immunophenotyping will be performed to test whether there are changes in cellular inflammation.
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Outcome will be measured at Baseline, 12 weeks and 24 weeks.
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Change in Depression
기간: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
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Change in depression will be measured with the Hospital Anxiety and Depression Scale (HADS).
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Outcome will be measured at Baseline, 12 weeks and 24 weeks.
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Change in Cognition
기간: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
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Changes in cognitive ability will be assessed by using the Brief International Cognitive Assessment for MS (BICAMS) test battery.
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Outcome will be measured at Baseline, 12 weeks and 24 weeks.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Aerobic Capacity
기간: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
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Participants will perform a progressive exercise test on the cycle ergometer to determine peak oxygen consumption (aerobic capacity).
Expired gas and ventilatory parameters will be acquired throughout the protocol using a metabolic cart allowing for the determination of submaximal and maximal oxygen consumption.
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Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
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Change in Muscle Strength
기간: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
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The maximum weight that can be lifted in one repetition (1RM) will be assessed in major muscle groups of the upper and lower body to assess muscle strength.
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Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
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Change in Perceived Quality of Life (QOL)
기간: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
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Health-related quality of life will be assessed by the disease-specific MS Quality of Life-54 (MSQoL-54) questionnaire.
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Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
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공동 작업자 및 조사자
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 (실제)
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
- RG-1707-28348
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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