Effect of Exercise on Patients With Claudication Undergoing Surgery
A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants
Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg?
Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as easily as a healthy leg would. This causes pain when walking (intermittent claudication), which often occurs after a reproducible distance e.g. every 50 yards. These patients have a reduction in their quality of life as they feel embarrassed in social situations e.g. walking around town requires multiple breaks, so they tend to avoid this and isolate themselves more.
One treatment for claudication is exercising until the pain comes on; which most are reluctant to do. Walking up to three times a week for an hour, can double most people's walking distances, but doesn't always. The reason why some improve with exercise and others do not remains unknown.
This project will be the first randomised controlled trial of exercise in claudicants that focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare muscle cells from a group that have exercised and group that have not. We will focus on the change in muscle cell size and function at present, and later progress to why and how this happens.
Methods: We will take measurements at the start of the study (baseline), after 6 weeks and then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking distances and blood samples. At the time of surgery, muscle from the calf will be taken from the affected leg. This will be processed at the University's biomedical science department to look at the different types of muscle fibre and how efficiently they are working.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hull, 영국, HU3 2JZ
- 모병
- Hull Royal Infirmary
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연락하다:
- Romesh Sarvanandan, MBBS MRCS
- 전화번호: 01482674643
- 이메일: romesh1985@doctors.org.uk
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수석 연구원:
- Romesh Sarvanandan, MBBS MRCS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Community dwelling older adults aged 45 and over
- Diagnosis of intermittent claudication - ABPI < 0.9 with symptoms in keeping with intermittent claudication
- Undergoing surgery for claudication
- Ability to walk without assistance
- Healthy control patients who are undergoing varicose vein surgery
Exclusion Criteria:
- Participants who are unable to provide informed consent
- Severe of acute cardiovascular, musculoskeletal or pulmonary illness
- Critical limb ischaemia
- Active treatment for cancer
- Rheumatoid arthritis or any patient receiving steroids or disease modifying Antirheumatic drugs (DMARDS)
- Failure to complete a CPET
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Supervised Exercise Program
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care
기간: 6 weeks
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Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness
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6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Measure the changes in muscle fibre type with exercise training or standard care
기간: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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Histological analysis to measure the percentage of different types of muscle fibres, and how these are affected by 6 weeks of exercise compared to standard treatment.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
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Measurement of endothelial function after a period or exercise therapy or standard care
기간: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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To identify if 6 weeks of exercise improves the endothelial function.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
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Measurement of inflammatory markers with exercise treatment or standard care
기간: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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To identify whether 6 weeks of exercise therapy improves inflammatory markers
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Romesh Sarvanandan, MBBS MRCS, Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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