Low Load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis

NCT04633759 | Completed

• 2 other identifiers: 20-0695205593
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) in people with multiple sclerosis (MS) who have moderate-to-severe walking problems. BFR training involves placing a cuff on the leg being exercised in order to restrict blood flow. The cuff is attached to a specialized device that automatically detects the appropriate amount of pressure to place on the limb. Testing will occur before and after the 8-week treatment period.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Blood Flow Restriction; Resistance Training

Outcome Measures

Primary Outcomes (3)

• Change in knee extension muscle strength

  Knee extension muscle strength measured by hand-held dynamometry

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in hip abduction muscle strength

  Hip abduction muscle strength measured by hand-held dynamometry

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in ankle plantarflexion muscle strength

  Ankle plantarflexion muscle strength measured by hand-held dynamometry

  Measured at Baseline (Week 0) and Post Test (Week 9)

Secondary Outcomes (8)

• Change in 30-second sit-to-stand completions

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in Berg Balance Scale

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in timed 25-foot walk

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in activity level

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in 12-Item MS Walking Scale

  Measured at Baseline (Week 0) and Post Test (Week 9)

Study Arms (1)

Blood Flow Restriction Exercise

EXPERIMENTAL

Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.

Other: Blood Flow Restriction Exercise

Interventions

Blood Flow Restriction Exercise OTHER

Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with up to 80% limb occlusion. Exercises will target bilateral 1) knee and hip extension, 2) hip abduction, and 3) ankle plantarflexion, as these muscles are important for functional mobility in people with MS.

Blood Flow Restriction Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18-70
• Neurologist-confirmed diagnosis of multiple sclerosis
• Expanded Disability Status Scale (EDSS) 6.0 to 7.0
• EDSS 6.0: unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting
• EDSS 6.5: Bilateral assistance (cane or crutch) required to walk at least 20 meters with or without resting
• EDSS 7.0: unable to walk 5 meters even with aid, essentially restricted to wheelchair; wheels self and transfers alone; up and about in wheelchair some 12 hours a day

You may not qualify if:

• EDSS 7.5 or greater: Restricted to wheelchair for all mobility, unable to walk more than a few steps, even with walking aid
• EDSS 5.5 or less: Able to walk more than 100 meters without walking aid or rest
• Unable to provide consent or follow simple directions
• Prior history of Deep Venous Thrombosis/ Pulmonary Embolism
• History of peripheral vascular disease, thrombophilia or other clotting disorders
• Patient report of easy bruising
• Any comorbid conditions or pain that substantially affects physical function or would interfere with the participant's ability to safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, or ongoing medical treatments) as determined by a neurologist of physical therapist
• Severe lower extremity spasticity as defined as Modified Ashworth scale \> 2
• Currently undergoing supervised resistance training with a physical therapist or other exercise professional
• Use of Blood Flow Restriction currently or in the previous 3 months prior to enrollment
• MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment
• Inability to tolerate pressure cuff during baseline assessment

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Consortium of Multiple Sclerosis Centers: collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Manago MM, Cohen ET, Cameron MH, Christiansen CL, Bade M. Reliability, Validity, and Responsiveness of the Patient-Specific Functional Scale for Measuring Mobility-Related Goals in People With Multiple Sclerosis. J Neurol Phys Ther. 2023 Jul 1;47(3):139-145. doi: 10.1097/NPT.0000000000000439. Epub 2023 Mar 7.

  PMID: 36897202 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: February 19, 2021
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (1)