Training StudyNCT05177952
Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis
A study testing Blood Flow Restriction in people with Training Study and Multiple Sclerosis, run by University of Central Florida at 1 site in United States.
Trial summary
This research is being done to compare the current standard of care for strength training for patients with Multiple Sclerosis to lightweight resistance training with blood flow restriction. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Training Study, Multiple Sclerosis, Blood Flow Restriction
- What is being tested?
- Blood Flow Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 May 2024
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females between the ages of 18 to 55
- Diagnosed with Multiple Sclerosis
- Expanded Disability Status Score of 0 to 6.5
- Able to walk 10 meters without assistance
- Are willing to come in for all 29 testing visits over 14 weeks
Who cannot join
- No other known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
- Multiple Sclerosis relapse in the past 30 days
- Are not currently undergoing a rehabilitation protocol
- Are not currently seeking medical care for a chronic condition that could limit exercise capacity other than multiple sclerosis
- Are not currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: The Chronic Effects of Low-Load Blood Flow Restriction or Standard of Care Resistance Exercise on Muscle and Neuromuscular Function in Patients With Multiple Sclerosis
This research is being done to compare the current standard of care for strength training for patients with Multiple Sclerosis to lightweight resistance training with blood flow restriction.
Read the detailed description
The purpose of this study is to compare the effectiveness of the current Multiple Sclerosis standard of care exercise recommendations to low-load resistance training with blood flow restriction on functional outcomes, strength, muscle size, and neuromuscular control in Multiple Sclerosis patients. This study involves completing 2 training sessions per week for 12 weeks as well as pre- and post-training assessment visits for a total of 29 visits over 14 weeks. All visits will be on UCF's campus with a member of the research team.
- Conditions
- Training Study, Multiple Sclerosis, Blood Flow Restriction
- Being tested
- Blood Flow Restriction, Standard of Care
- Keywords
- Blood Flow Restriction, Multiple Sclerosis, Exercise
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionOther
Resistance training with BFR
Standard of CareOther
Resistance Training with no BFR
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction | Experimental | The BFR group will complete 1 set of 30 (1 x 30) at 30% of their 1 repetition maximum for leg press, leg extension, leg curl, chest press, seated row, and shoulder press completed on exercise machines with 2 minutes between exercises. Receives: Other: Blood Flow Restriction |
| Standard of Care | Active comparator | The standard of care group will complete 1 set of 8-12 repetitions at 60-80% of their 1 repetition maximum for leg press, leg extension, leg curl, chest press, seated row, and shoulder press completed on exercise machines with 2 minutes between exercises. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Outcomes- 10meter
determined via changes in 10 meter walk test, measured by how fast (in minutes and seconds) someone can walk 10 meters
Measured: Day 2, Week 4 and 8, Day 28
Change in Functional Outcomes- 6min walk
determined via changes in 6 minute walk test, measured by how far (in feet) someone can walk in 6 minutes
Measured: Day 2, Week 4 and 8, Day 28
Change in Functional Outcomes- CST
determined via changes in sit-to-stand test, measured by how quickly someone can stand from a seated position
Measured: Day 2, Week 4 and 8, Day 28
Change in Functional Outcomes- 30CST
determined via changes in 30 second sit-to-stand, measured by how many times someone can stand from a seated position in 30 seconds
Measured: Day 2, Week 4 and 8, Day 28
Change in Functional Outcomes- MFIS
determined via changes in Modified Fatigue Impact Scale Questionnaire, sum score of answers on the questionnaire
Measured: Day 2, Week 4 and 8, Day 28
Secondary outcomes (1)
Changes in Strength
determined via maximal voluntary contractions on the Biodex
Measured: Day 3, Week 4 and 8, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Training StudyStudies 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
- Randomized between group parallel
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- AdventHealth
- Responsible party
- Sponsor
- Investigators
- Ethan Hill, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177952
- Sponsor's protocol ID
- STUDY00003396: BFR MS
- Status last verified
- Jun 2024
- First submitted
- 8 Dec 2021
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt JT, Reedy KR, Lubiak SM, Howard MA, Proppe CE, Rivera PM, Gonzalez-Rojas DH, Lawson JE, Cardona C, Hill EC. The Impact of Blood Flow Restriction and Resistance Training on Functional Outcomes and Fatigue in People with Multiple Sclerosis. Med Sci Sports Exerc. 2025 Oct 1;57(10):2138-2147. doi: 10.1249/MSS.0000000000003747. Epub 2025 May 1.
PubMed 40307994
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Effects of Low-Load Blood Flow Restriction or Standard of Care Resistance Exercise on Muscle and Neuromuscular Function in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05177952
- Acronym / sponsor ID
- STUDY00003396: BFR MS
- Conditions
- Training Study, Multiple Sclerosis, Blood Flow Restriction
- Keywords
- Blood Flow Restriction, Multiple Sclerosis, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- AdventHealth
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 5 Jan 2022 (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.
This research is being done to compare the current standard of care for strength training for patients with Multiple Sclerosis to lightweight resistance training with blood flow restriction.
Detailed description
The purpose of this study is to compare the effectiveness of the current Multiple Sclerosis standard of care exercise recommendations to low-load resistance training with blood flow restriction on functional outcomes, strength, muscle size, and neuromuscular control in Multiple Sclerosis patients. This study involves completing 2 training sessions per week for 12 weeks as well as pre- and post-training assessment visits for a total of 29 visits over 14 weeks. All visits will be on UCF's campus with a member of the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized between group parallel
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction | Experimental | Other: Blood Flow RestrictionThe BFR group will complete 1 set of 30 (1 x 30) at 30% of their 1 repetition maximum for leg press, leg extension, leg curl, chest press, seated row, and shoulder press completed on exercise machines with 2 minutes between exercises. |
| Standard of Care | Active comparator | Other: Standard of CareThe standard of care group will complete 1 set of 8-12 repetitions at 60-80% of their 1 repetition maximum for leg press, leg extension, leg curl, chest press, seated row, and shoulder press completed on exercise machines with 2 minutes between exercises. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females between the ages of 18 to 55
- Diagnosed with Multiple Sclerosis
- Expanded Disability Status Score of 0 to 6.5
- Able to walk 10 meters without assistance
- Are willing to come in for all 29 testing visits over 14 weeks
Key exclusion criteria (5 listed)
- No other known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
- Multiple Sclerosis relapse in the past 30 days
- Are not currently undergoing a rehabilitation protocol
- Are not currently seeking medical care for a chronic condition that could limit exercise capacity other than multiple sclerosis
- Are not currently pregnant
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 |
|---|---|---|
| Blood Flow RestrictionResistance training with BFR | Other | Blood Flow Restriction |
| Standard of CareResistance Training with no BFR | Other | Standard of Care |
Primary outcome
Change in Functional Outcomes- 10meter
Time frame: Day 2, Week 4 and 8, Day 28
determined via changes in 10 meter walk test, measured by how fast (in minutes and seconds) someone can walk 10 meters
Change in Functional Outcomes- 6min walk
Time frame: Day 2, Week 4 and 8, Day 28
determined via changes in 6 minute walk test, measured by how far (in feet) someone can walk in 6 minutes
Change in Functional Outcomes- CST
Time frame: Day 2, Week 4 and 8, Day 28
determined via changes in sit-to-stand test, measured by how quickly someone can stand from a seated position
Change in Functional Outcomes- 30CST
Time frame: Day 2, Week 4 and 8, Day 28
determined via changes in 30 second sit-to-stand, measured by how many times someone can stand from a seated position in 30 seconds
Change in Functional Outcomes- MFIS
Time frame: Day 2, Week 4 and 8, Day 28
determined via changes in Modified Fatigue Impact Scale Questionnaire, sum score of answers on the questionnaire
1 secondary outcome
Changes in Strength
Time frame: Day 3, Week 4 and 8, Day 29
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 11 Jun 2024.
- Derived from this study: PubMed 40307994Schmidt JT, Reedy KR, Lubiak SM, Howard MA, Proppe CE, Rivera PM, Gonzalez-Rojas DH, Lawson JE, Cardona C, Hill EC. The Impact of Blood Flow Restriction and Resistance Training on Functional Outcomes and Fatigue in People with Multiple Sclerosis. Med Sci Sports Exerc. 2025 Oct 1;57(10):2138-2147. doi: 10.1249/MSS.0000000000003747. Epub 2025 May 1.
- Individual participant dataSharing planned: No
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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.
Ethan Hill, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction in people with Training Study and Multiple Sclerosis, run by University of Central Florida at 1 site in United States.
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 5 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 11 Jun 2024. 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 United States. 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?
Change in Functional Outcomes- 10meter (time frame: Day 2, Week 4 and 8, Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05177952, which also lists 1 linked publication.
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 11 Jun 2024.