跳至主要内容
临床试验/NCT03153553
NCT03153553已完成不适用

Ischemic Preconditioning, Exercise Tolerance and Multiple Sclerosis

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Ability to tolerate Ischaemic Preconditioning (IPC_

研究概览

简要总结

Regular physical activity improves aspects such as physical fitness, fatigue, quality of life, gait and also reduces the rate of progression of disability in individuals with Multiple Sclerosis. However, individuals with multiple sclerosis are less physically active than the general population. The determinants of engaging in physical activity for individuals with multiple sclerosis include psychological factors like motivation, self-belief and self-regulatory constructs and physical factors like fatigue, weakness, pain and ataxia.

Ischemic preconditioning is exposure of the body to brief periods of circulatory occlusion and re-perfusion to protect organs against ischemic injury. Recent studies have also shown that ischemic preconditioning also improves exercise performance in healthy participants.

The primary aim and objective of this study is to see whether it is feasible to use Ischemic preconditioning to improve exercise performance in people with Multiple Sclerosis.

The design for the study is a double blind randomized control trial. Forty patients with multiple sclerosis above 18 years of age and who have the ability to walk will be randomized to receive either Ischemic preconditioning or sham intervention. All participants will be identified by MS consultants and nurses from the MS clinic and Neuro Day Case Unit of the Royal Hallamshire Hospital in Sheffield. Participation will involve an additional 2 hours of the patients time.

详细描述

This project is quantified as a Feasibility study. The design for the study is a double blind randomised control trial. Forty patients with MS above 18 years and who have the ability to walk will be randomised to receive either IPC or sham intervention. Potential candidates will be identified from the MS clinic and Neuro Day Case Unit of the Royal Hallamshire Hospital (RHH) in Sheffield.

All participants will be identified by MS consultants and nurses from MS clinics and from neuroday case unit of Royal Hallamshire Hospital. The patient information sheet will be mailed to the participants deemed suitable for the trial by the treating team. The participants will be given up to two weeks to consider their participation in the trial. Patients wishing to participate will be consented by Dr Siva Nair/Kate Lavender/Dr Ismail, following consent Dr Nair/Kate Lavender/ Dr Ismail will ensure the participants are randomised into the treatment group or the control group using a random number table. The MSc student will act as blinded assessor.

After obtaining consent, the research team will conduct checks against the inclusion criteria to assess whether the participant fulfils the criteria for entry into the study. The participant will then be allocated into one of the two groups using a random number table: Experimental group or the Sham group. Participants will not be told which group they have been randomised to. The researcher will check the participant's blood pressure and heart rate while sitting. Then the researcher will request the participant to walk for six minutes as they normally walk. The researcher will measure the distance covered in 6 minutes and will ask the participant to grade the exertion experienced using Borg's Rating of Perceived Exertion scale. The researcher will again measure the blood pressure and heart rate again.

In the active comparator group The participant will rest in a sitting position for 10 minutes before measuring resting blood pressure. Blood pressure will be measured on the arm. IPC will be administered to the upper arm using cuff inflation pressures of 30mm Hg above the systolic BP using a manual BP. The IPC cycles comprised of three cycles of cuff inflation each lasting 5 min in duration followed by 5-min period of cuff deflation.

Within the sham intervention The participant will rest in a sitting position for 10 min before measuring resting blood pressure. Blood pressure will be measured on the upper arm. Sham intervention will be administered to the right upper limb using a manual BP cuff which will be inflated at a pressure 30mmg Hg below the diastolic blood pressure. The sham cycles comprised of three cycles of cuff inflation each lasting 5 minutes in duration followed by 5-min period of cuff deflation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

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

  • Diagnosis of MS as per the McDonald's criteria
  • Aged 18 or older
  • Sufficient cognitive ability to give informed consent
  • Ability to walk for 6 minutes without rest
  • Resting Systolic BP of less than 170 mmHg

排除标准

  • Cognitive difficulties in giving consent ad understanding the questionnaire
  • Inability to walk
  • Other systemic illness affecting exercise tolerance
  • Resting systolic BP of 170mmHg or more

结局指标

主要结局

Ability to tolerate Ischaemic Preconditioning (IPC_

时间窗: One day

Patients will be asked to indicate the tolerability of IPC using a visual analogue scale from 0-10 (0 no symptoms and 10 intolerable symptoms).

次要结局

  • Perceived rate of exertion(One day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验