Proximal Resistance Training for People With Multiple Sclerosis

NCT04548154 | Completed

• 2 other identifiers: 20-1527K12HD055931
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to pilot a 10-week resistance and functional movement intervention targeting proximal muscles in 40 people with MS. The investigators will assess implementation feasibility (recruitment, fidelity, retention, satisfaction), collect pilot data for key walking function outcomes, and examine movement-pattern and activity behavior mechanisms. Walking function will be measured by walking capacity (6-Minute Walk Test - 6MWT) and PA quantity (average steps/ day over 10 days). Movement-pattern mechanisms will be measured using 3D motion capture analysis (pelvis and trunk kinematics). Activity behavior mechanisms will be measured by patient-reported outcome questionnaires (perception of walking ability, self-efficacy, and readiness to change).

Conditions

Multiple Sclerosis

Keywords

Exercise; Hip abduction; Trunk muscles

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk test

  The 6MWT assesses walking endurance via the maximal distance an individual is able to walk in 6 minutes, reported in meters

  Baseline, end of 10 week intervention period, 22 week follow-up.

Secondary Outcomes (7)

• Change in average daily step count

  Baseline, end of 10 week intervention period, 22 week follow-up.

• Change in movement patterns

  Baseline, end of 10 week intervention period, 22 week follow-up.

• Change in Multiple Sclerosis Walking Scale-12

  Baseline, end of 10 week intervention period, 22 week follow-up.

• Change in Multiple Sclerosis Self-Efficacy Score

  Baseline, end of 10 week intervention period, 22 week follow-up.

• Change in Exercise Self-Efficacy Scale

  Baseline, end of 10 week intervention period, 22 week follow-up.

Other Outcomes (6)

• Change in Patient-Specific Functional Scale

  Baseline and end of 10 week intervention period.

• Change in hip abduction strength

  Baseline, end of 10 week intervention period, 22 week follow-up.

• Change in lateral trunk flexion strength

  Baseline, end of 10 week intervention period, 22 week follow-up.

Study Arms (1)

Proximal Resistance Training

EXPERIMENTAL

Participants will receive 6 one-on-one supervised intervention visits and 8 telerehabilitation visits over 10 weeks. For the first 4 weeks intervention frequency will start with 1x/ week in clinic and 1x/ week via telerehabilitation, and the participant will be asked to perform exercises 2x/ week independently. For the final 6 weeks there will be 1x week supervised visits (weeks 6 and 8 in person, and weeks 5,7, 9, and 10 via telerehabilitation) and the participant will be asked to perform exercises 3x/ week independently.

Other: Proximal Resistance Training

Interventions

Proximal Resistance Training OTHER

Participants will be prescribed 5 categories of resistance exercises, and each category will have a series of exercises to select from. Two will target hip abduction, two will target trunk muscles, and one will target functional resistance training for the hip and trunk during walking-related tasks such as multi-directional resisted walking. Dosing will be based on guidelines for MS. Strengthening exercises will begin with 3 sets of 12-15 reps at 15 rep-max load (RM) and progress to 3 sets of 8-10 reps at 10-12 RM. Endurance exercises requiring a static hold will progress from 3 sets of 15-20 second holds to 30-second holds. Functional resistance will be dosed to improve muscular endurance: 3 sets of 15-20 reps based on form fatigue.

Proximal Resistance Training

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Neurologist-confirmed diagnosis of MS
• Able to walk at least 100 meters without an assistive device
• Expanded Disability Status Scale - EDSS \< 6
• Have their own tablet/phone/computer capable of video calls/Zoom meetings.

You may not qualify if:

• Other conditions limiting their ability to exercise or walk
• Unsafe to exercise as determined by a neurologist or physical therapist
• Currently undergoing physical therapy
• Unable to provide consent or follow simple directions
• Have an MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment
• A 25 foot walk test time of \> 4.5 seconds

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institutes of Health (NIH): 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; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark M. Manago, DPT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

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: September 8, 2020
• First Posted: September 14, 2020
• Study Start: October 12, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: We will publish the trial results within one year of testing the final participant.
• Access Criteria: User registration will be required to access/download any data and will require agreement to conditions of use in accordance with NIH Data Sharing Policy Guidelines.

Locations

US (1)