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临床试验/NCT02950454
NCT02950454已完成不适用

The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.

University of Glasgow2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
heart rate max

研究概览

简要总结

This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks.

详细描述

This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks.

The training program will entail 6x1.5 minute intervals working at 80-95% heart rate max on a cycle ergometer. Each interval will be interspersed with 1.5 minutes of working rest at a light resistance of the participant's choosing.

The continuous moderate intensity exercise program will entail 20 minutes on a cycle ergometer working at 60-70% heart rate max.

研究设计

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

入排标准

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

入选标准

  • Diagnosed with a progressive form of MS
  • Aged 18 years or older
  • Known to members of staff of the MS service NHS Ayrshire & Arran
  • Ability to attend Douglas Grant Rehabilitation centre twice a week for eight weeks
  • EDSS 4-6.0
  • Able to cycle on ergometer

排除标准

  • A relapse of symptoms requiring treatment within the past three months.
  • A respiratory condition that would be exacerbated by high intensity exercise including but not limited to: chronic obstructive pulmonary disorder, uncontrolled or poorly controlled asthma.
  • Uncontrolled high pressure at screening (>190/100 mmHg)
  • Cognitive impairment affecting ability to understand instructions as noted in patient's notes.
  • Currently engaging in another research trial for their MS or that may affect their physiological or cardiovascular outcomes
  • Weighing more than 110 kg (weight limit of ergometer)
  • Any pathology or medical intervention that would preclude high intensity exercise, maximal exertion testing or could attenuate the cardiovascular effect of exercise including but not limited to: unstable angina; diabetes; peripheral vascular disease or intermittent claudication; having a pace maker or medicine pump; surgical clips; having another neurological condition other than MS; and pregnancy. To be established from patient's notes and at screening session.
  • A serious cardiovascular event in the past year including but not limited to: transient ischaemic attack, cerebrovascular event and myocardial infarction.
  • Taking any of the following medication: beta blockers; vasodilators; ACE inhibitors; diuretics or any other medication that could cause exercise induced hypotension; hypoglycaemic insulin; metformin or other oral insulin medicine.

研究组 & 干预措施

Intervention

Experimental

8 weeks of twice weekly high intensity interval training. Session protocol: 2 minute warm up at nominal resistance on cycle ergometer, 6 six intervals of 80-95% heart rate max interspersed with 6 intervals of 1.5 minute working rest. Then 3 minutes cool down.

干预措施: High intensity interval training (Other)

control

Active Comparator

8 weeks of twice weekly continuous moderate intensity exercise. Session protocol: 2 minutes warm up at nominal resistance on cycle ergometer, 20 minutes at 60-70% heart rate max. Then 3 minutes cool down.

干预措施: Continuous moderate exercise (Other)

结局指标

主要结局

heart rate max

时间窗: 8 weeks

Maximal heart rate elicited during a maximal exertion test

次要结局

  • Symbol digit modalities test(8 weeks)
  • Resting heart rate(8 weeks)
  • Brain derived neurotrophic factor(8 weeks)
  • Fatigue severity scale(8 weeks)
  • Resting blood pressure(8 weeks)
  • Lactate(8 weeks)
  • Timed 25 foot walk test(8 weeks)
  • Lipoprotein profile(8 weeks)
  • MSIS-29 version 2(8 weeks)
  • Hospital anxiety and depression scale(8 weeks)

研究者

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

Evan Campbell

PhD Student

University of Glasgow

研究点 (2)

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