NCT05177952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2.1 years

First QC Date

December 8, 2021

Last Update Submit

June 10, 2024

Conditions

Training StudyMultiple SclerosisBlood Flow Restriction

Keywords

Blood Flow RestrictionMultiple SclerosisExercise

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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

    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

    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

    Day 2, Week 4 and 8, Day 28

Secondary Outcomes (1)

  • Changes in Strength

    Day 3, Week 4 and 8, Day 29

Study Arms (2)

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.

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.

Other: Standard of Care

Interventions

Blood Flow RestrictionOTHER

Resistance training with BFR

Blood Flow Restriction
Standard of CareOTHER

Resistance Training with no BFR

Standard of Care

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Interventions

Blood Flow Restriction TherapyStandard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ethan Hill, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and Investigators will be aware of treatment groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized between group parallel
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 5, 2022

Study Start

January 1, 2022

Primary Completion

January 31, 2024

Study Completion

May 31, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)