Effects of Low-intensity Interval Walking With Blood Flow Restriction on Functional Capacity in M… (NCT03544177) | Clinical Trial Compass
CompletedNot Applicable
Effects of Low-intensity Interval Walking With Blood Flow Restriction on Functional Capacity in Multiple Sclerosis
Italy24 participantsStarted 2018-05-21
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Timed 25-foot Walk test
Timeframe: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)