Multiple SclerosisNCT03544177
Effects of Low-intensity Interval Walking With Blood Flow Restriction on Functional Capacity in Multiple Sclerosis
A study testing BFR-Walking and Conventional therapy in people with Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BFR-Walking and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Multiple Sclerosis
- Being tested
- BFR-Walking, Conventional therapy
- Keywords
- mobility, exercise therapy, blood flow restricted exercise, rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR-WalkingOther
Participants will perform 12 training sessions over 6 weeks, including a 10-minute warm up and cool down period. Patients will perform 5 six-minute bouts of over ground intermittent walking exercise (1-minute walk/rest) with their habitual walking device at a prescribed speed maintained by a metronome, starting from 60 steps/minute. A fixed resting period of 3 minutes will follow each walking bout. During walking, participants will wear BFR bands at both tights. Before every walking bout, the bands will be tightened at a low intensity (max 40% of blood systolic pressure) and untied at the end of every walking bout when patients will be asked to grade their RPE (Borg Scale). Walking speed will be weekly increased by 3 steps/minute, if the previous level was well-tolerated by the patient.
Conventional therapyOther
Participants will perform 12 training sessions over 6 weeks. Patients will perform assisted over-ground walking for a total of around 40 minutes, inserted between a 10-minute warm-up and cool-down period. The patient will be encouraged by the same experienced physiotherapist to walk back and forth on 50-meter indoor flat corridor with their habitual walking device. Patient will be asked to walk without stopping until reaching an effort corresponding to a value of 8 out of 10 of the rating of perceived exertion (Borg scale). When the exertion level is reached, the patients will be allowed to rest sitting on a chair if necessary; after a suitable rest period, when patients express sufficient desire to start again, the training will restart
| Study group | Role | What they receive |
|---|---|---|
| BFR-Walking | Experimental | Interval walking training with blood flow restriction. Receives: Other: BFR-Walking |
| Conventional therapy | Active comparator | Conventional therapy Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed 25-foot Walk test
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.
Measured: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)
Secondary outcomes (6)
6-Minute Walking Test
Subjects will be instructed to walk up and down as far as possible on a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary. The total distance walked will be recorded.
Measured: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)
Berg Balance Scale
To evaluate the ability to maintain balance statically or while performing functional movement. It includes 14 observable tasks common to an everyday life measured on a 5-point ordinal scale.
Measured: 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
Patient stand on a 43-cm chair with his/her arms folded across the chest and the back against the chair. Then the patient will be instructed as follow: "I want you to stand up and sit down 5 times as quickly as you can". The time to complete the 5 repetitions will be recorded.
Measured: 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
This is a 29-item self-report measure with 20 items associated with a physical function scale and 9 items with a psychological function scale. Items ask about the impact of MS on everyday life in the past two weeks with possible answers set on a 1-5 Likert scale. Each of the two scales is converted to a 0-100 scale where a score of 100 indicates a greater impact of disease on daily function.
Measured: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)
Fatigue Severity Scale
The scale consists of answering short questions that require the subject to read each statement and rate his or her level of fatigue from 1 to 7, depending on how appropriate they felt the statement applied to them over the preceding week.
Measured: 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
This is a generic measurement to assess health-related quality of life. It consists of 8 sub-scales with a score ranging from 0-100 used separately as outcome measures of various aspects of health-related-quality of life. It also measures two main health concepts: physical and mental health.
Measured: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start21 May 2018
- Primary completion30 Sep 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center pilot randomized parallel group clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Manfredini, MD, Principal investigator, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544177
- Sponsor's protocol ID
- 170783
- Status last verified
- Jan 2020
- First submitted
- 18 May 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results published at the end of the trial after deidentification. The database of the study will be published in a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03544177
- Acronym / sponsor ID
- 170783
- Conditions
- Multiple Sclerosis
- Keywords
- mobility, exercise therapy, blood flow restricted exercise, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center pilot randomized parallel group clinical trial
| Arm | Type | Receives |
|---|---|---|
| BFR-Walking | Experimental | Other: BFR-WalkingInterval walking training with blood flow restriction. |
| Conventional therapy | Active comparator | Other: Conventional therapyConventional therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFR-WalkingParticipants will perform 12 training sessions over 6 weeks, including a 10-minute warm up and cool down period. Patients will perform 5 six-minute bouts of over ground intermittent walking exercise (1-minute walk/rest) with their habitual walking device at a prescribed speed maintained by a metronome, starting from 60 steps/minute. A fixed resting period of 3 minutes will follow each walking bout. During walking, participants will wear BFR bands at both tights. Before every walking bout, the bands will be tightened at a low intensity (max 40% of blood systolic pressure) and untied at the end of every walking bout when patients will be asked to grade their RPE (Borg Scale). Walking speed will be weekly increased by 3 steps/minute, if the previous level was well-tolerated by the patient. | Other | BFR-Walking |
| Conventional therapyParticipants will perform 12 training sessions over 6 weeks. Patients will perform assisted over-ground walking for a total of around 40 minutes, inserted between a 10-minute warm-up and cool-down period. The patient will be encouraged by the same experienced physiotherapist to walk back and forth on 50-meter indoor flat corridor with their habitual walking device. Patient will be asked to walk without stopping until reaching an effort corresponding to a value of 8 out of 10 of the rating of perceived exertion (Borg scale). When the exertion level is reached, the patients will be allowed to rest sitting on a chair if necessary; after a suitable rest period, when patients express sufficient desire to start again, the training will restart | Other | Conventional therapy |
Primary outcome
Timed 25-foot Walk test
Time frame: 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.
6 secondary outcomes
6-Minute Walking Test
Time frame: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)
Berg Balance Scale
Time frame: 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
Time frame: 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
Time frame: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)
Fatigue Severity Scale
Time frame: 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
Time frame: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published at the end of the trial after deidentification. The database of the study will be published in a public repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Manfredini, MD principal investigator
University Hospital of Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR-Walking and Conventional therapy in people with Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25-foot Walk test (time frame: Baseline (prior to the first exercise session, T0); end of the treatment (after 6 weeks, T1); follow-up (after 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.