CClinicalTrials.gg
CompletedNCT05177952Updated Jun 11, 2024

Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

An interventional study of Blood Flow Restriction and Standard of Care in Training Study, Multiple Sclerosis and Blood Flow Restriction, sponsored by University of Central Florida. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by University of Central Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Training Study
  • Multiple Sclerosis
  • Blood Flow Restriction

Keywords

  • Blood Flow Restriction
  • Multiple Sclerosis
  • Exercise
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Central Florida is the lead sponsor of 99 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Blood Flow Restriction

    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.

    Other: Blood Flow Restriction

  • Active comparator
    Standard of Care

    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.

    Other: Standard of Care

Interventions

  • OtherBlood Flow Restriction

    Resistance training with BFR

  • OtherStandard of Care

    Resistance Training with no BFR

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 2, Week 4 and 8, Day 28

  2. 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

    Time frame: Day 2, Week 4 and 8, Day 28

  3. Change in Functional Outcomes- CST

    determined via changes in sit-to-stand test, measured by how quickly someone can stand from a seated position

    Time frame: Day 2, Week 4 and 8, Day 28

  4. 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

    Time frame: Day 2, Week 4 and 8, Day 28

  5. Change in Functional Outcomes- MFIS

    determined via changes in Modified Fatigue Impact Scale Questionnaire, sum score of answers on the questionnaire

    Time frame: Day 2, Week 4 and 8, Day 28

Secondary outcomes

  1. Changes in Strength

    determined via maximal voluntary contractions on the Biodex

    Time frame: Day 3, Week 4 and 8, Day 29

07

Study locations

1 site
  • University of Central Florida
    Orlando, Florida 32816, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05177952
Lead sponsor
University of Central Florida
Collaborators
AdventHealth
Responsible party
Sponsor
First posted
Jan 5, 2022
Start date
Jan 1, 2022
Primary completion
Jan 31, 2024
Completion
May 31, 2024
Last update
Jun 11, 2024

Study contacts

Ethan Hill, PhD
principal investigator · University of Central Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion