跳至主要内容
临床试验/NCT01980602
NCT01980602Unknown不适用

A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants

University of Hull1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Supervised Exercise Program

Experimental

干预措施: Supervised Exercise program (Procedure)

结局指标

主要结局

Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care

时间窗: 6 weeks

Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness

次要结局

  • Measurement of endothelial function after a period or exercise therapy or standard care(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • Measurement of inflammatory markers with exercise treatment or standard care(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • Measure the changes in muscle fibre type with exercise training or standard care(Baseline, 6 weeks, 3 months, 6 months, and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Carradice

Academic Clinical Lecturer

University of Hull

研究点 (1)

Loading locations...

相似试验