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Completed

NCT Number: NCT05177952

Low-Load Blood Flow Restriction on 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.

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Key information

Conditions

Training Study Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Blood Flow Restriction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Multiple Sclerosis Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Blood Flow Restriction

Other

Resistance training with BFR

Standard of care

Other

Resistance Training with no BFR

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Changes in Strength

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

    determined via maximal voluntary contractions on the Biodex

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • AdventHealth

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2022
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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