Effects of Low-intensity Interval Walking With Blood Flow Restriction on Gait Speed and Functional Impairments in Patients With Severe Multiple Sclerosis: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Timed 25-foot Walk test
研究概览
简要总结
The aim of the study is to evaluate the safety, feasibility and initial efficacy of an interval-based walking training at low speed performed with blood flow restriction (BFR) on gait speed and functional impairments in patients with Multiple Sclerosis (MS).
Patients with severe MS will be recruited at outpatient rehabilitation clinics (University Hospital of Ferrara). Eligible participants will be randomized to interval walking training with BFR (the experimental group) or conventional exercise therapy (the control group) according to a blocked-randomization stratified by gender with 1:1 ratio. Both groups will receive 12 rehabilitative sessions over 6 weeks, for a 2 sessions/week pattern.
The experimental group will undergo interval-based walking training at a slow speed according to a walk:rest ratio of 1:1 for a total of 6 minutes, to be repeated 5 times. Blood flow restriction, applied to the proximal thigh, will be set at a maximum of 40% of systolic blood pressure. The control group will be treated with conventional therapy.
Changes in gait speed, endurance, balance, lower limbs strength and quality of life will be assessed at baseline, at the end of training, and at follow up.
The proposed training modality has never been tested in patients with MS and, if the hypotheses were supported by the results, might be a novel tool to improve muscle strength with a positive impact on gait disabilities, balance and quality of life for patients with MS.
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
- Single (Outcomes Assessor)
盲法说明
Outcome measures assessors, blinded to group allocation, will not have access to the randomization list and unblinding will not be possible for these researchers.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary and secondary progressive MS patients according to the diagnostic MS criteria revised by Polman et al.
- •Male and females, aged 18 to 65 years;
- •Severe gait impairments, defined by an Expanded Disability Status Scale (EDSS) ranging from 5.5 to 6.5;
- •Lack of MS worsening in the previous three months prior to the intervention period;
- •Cognitive functioning to provide informed consent identified by a Mini-Mental Status Examination (MMSE) score = 24/30.
排除标准
- •Neurologic conditions in addition to MS that may affect motor function and other medical conditions likely to interfere with the ability to complete safely the study protocol, independently from the group assignment;
- •Considerable muscle spasticity, defined by a Modified Ashworth Scale (MAS) score > 3 or contractures that may limit range of motion or function for hip, knee or ankle flexors/extensor;
- •Relapsing of MS-related conditions or changes in drug therapy or any other confounding factor during the study;
- •Rehabilitation treatments or Botulinum toxin injections during the three months preceding the start of the study.
- •Intermittent claudication and peripheral artery disease
- •Contraindication to exercise training (e.g., unstable angina, congestive heart failure)
研究组 & 干预措施
BFR-Walking
Interval walking training with blood flow restriction.
干预措施: BFR-Walking (Other)
Conventional therapy
Conventional therapy
干预措施: Conventional therapy (Other)
结局指标
主要结局
Timed 25-foot Walk test
时间窗: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)
The patient will be directed to one end of a clearly marked 25-foot course and will be instructed to walk 25 feet (7.62 m) as quickly as possible, but safely, using the prescribed assistive devices. The task is immediately administered again by having the patient walk back the same distance. The test will be performed according to the instructions reported on the manual of the National Multiple Sclerosis Society. To ensure an accurate and objective measure of the primary outcome, the time needed for each subject to complete the test will be collected with the aid of a photocells system with a precision of a millisecond and simultaneously by the assessors with a chronometer. The walking speed will be calculated as the mean of the two trials performed.
次要结局
- 6-Minute Walking Test(Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks))
- Berg Balance Scale(Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks))
- Multiple Sclerosis Impact Scale(Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks))
- Short Form Health Survey 36(Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks))
- 5-time Sit-to-Stand test(Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks))
- Fatigue Severity Scale(Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks))