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Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

Primary Purpose

Training Study, Multiple Sclerosis, Blood Flow Restriction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction
Standard of Care
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Training Study focused on measuring Blood Flow Restriction, Multiple Sclerosis, Exercise

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Central FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood Flow Restriction

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
Change in Functional Outcomes- CST
determined via changes in sit-to-stand test, measured by how quickly someone can stand from a seated position
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
Change in Functional Outcomes- MFIS
determined via changes in Modified Fatigue Impact Scale Questionnaire, sum score of answers on the questionnaire

Secondary Outcome Measures

Changes in Strength
determined via maximal voluntary contractions on the Biodex

Full Information

First Posted
December 8, 2021
Last Updated
December 15, 2021
Sponsor
University of Central Florida
Collaborators
AdventHealth
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1. Study Identification

Unique Protocol Identification Number
NCT05177952
Brief Title
Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida
Collaborators
AdventHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Training Study, Multiple Sclerosis, Blood Flow Restriction
Keywords
Blood Flow Restriction, Multiple Sclerosis, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized between group parallel
Masking
None (Open Label)
Masking Description
Participants and Investigators will be aware of treatment groups
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Restriction
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction
Intervention Description
Resistance training with BFR
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Resistance Training with no BFR
Primary Outcome Measure Information:
Title
Change in Functional Outcomes- 10meter
Description
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
Title
Change in Functional Outcomes- 6min walk
Description
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
Title
Change in Functional Outcomes- CST
Description
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
Title
Change in Functional Outcomes- 30CST
Description
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
Title
Change in Functional Outcomes- MFIS
Description
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 Outcome Measure Information:
Title
Changes in Strength
Description
determined via maximal voluntary contractions on the Biodex
Time Frame
Day 3, Week 4 and 8, Day 29

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola M Rivera, MS
Phone
786-348-8080
Email
paola.rivera@ucf.edu
First Name & Middle Initial & Last Name & Degree
Chris Proppe
Email
cproppe@knights.ucf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

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