Proximal Resistance Training for People With Multiple Sclerosis (PT-MS)

Proximal Resistance Training to Improve Walking Capacity and Physical Activity in People With Multiple Sclerosis: A Feasibility Study

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Proximal Resistance Training

Detailed Description

The proposed study will be a prospective cohort in 40 people with MS with one baseline and one follow-up assessment after a 10-week functional resistance training intervention. The screening and outcome assessments will take place in the CU Interdisciplinary Movement Science Lab and intervention will occur in the CU Physical Therapy Program gym. Both facilities have the necessary space and equipment for outcomes assessment and intervention, respectively. The PI will perform the initial screening and deliver the intervention. In order to limit testing bias, all functional tests, patient-reported outcomes, and motion capture data collection will be performed by an experienced research assistant.

Participants will receive 14 one-on-one supervised intervention visits over 10 weeks. Intervention frequency will mimic clinical practice, starting at 2x/ week in clinic (2x/ week independently) for four weeks and tapering to 1x/ week in clinic (3x/ week independently) for the final six weeks. 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 (lying down and standing), two will target trunk muscles (sidelying/ forward planks, resisted trunk rotation), 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. Progression will be achieved by modifying body position, and/or adding cuff weights or resistance bands. Exercises will take 30-45 minutes to complete. Upper extremity use to maintain balance will be allowed as needed.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria.

• 18-64 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.

Exclusion Criteria.

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Proximal Resistance Training; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average daily step count	Step count will be measured by waist-mounted ActiGraph accelerometer-based activity monitors	Baseline, end of 10 week intervention period, 22 week follow-up.
Change in movement patterns	Mechanisms of movement patterns will be measured by 3-dimensional motion capture analysis during self-selected walking speed and during a 30 second chair raise test.	Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Multiple Sclerosis Walking Scale-12	A 12 questions assessment of self-reported walking mobility in people with multiple sclerosis. Scores range from 0 to 100 with higher scores indicating better mobility.	Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Multiple Sclerosis Self-Efficacy Score	An 18 item assessment of measures of self-efficacy in multiple sclerosis including a function component and a control component. Total score is reported on a 10-100 point scale with higher scores indicating greater certainty in ones ability to manage multiple sclerosis symptoms.	Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Exercise Self-Efficacy Scale	A 9 item questionnaire that assesses perceptions about ability to participate in at least 20 minutes of moderate physical activity 3x per week. Scores range from 0 to 90 points with higher scores indicating more confidence to exercise in different circumstances.	Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Exercise Stages of Change category	A 4 item measure to assess readiness to participate in exercise and activity. Depending on the answers to the yes/no questions, results are categorized as "pre-contemplation", "contemplation", "preparation", "action", and "maintenance".	Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Modified Fatigue Impact Scale	The standard measure of patient-reported limitations due to fatigue in people with MS. Scores range from 0 to 84 with higher scores indicating higher impact of fatigue on daily activities.	Baseline, end of 10 week intervention period, 22 week follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Specific Functional Scale	Participant identifies 3 activities that the participant is unable to do, or is difficult for the participant to do and rates them on a 10-point scale, with higher scores indicating greater ability to perform activity.	Baseline and end of 10 week intervention period.
Change in hip abduction strength	Hip abduction strength will be measured in kg using hand-held dynamometry.	Baseline, end of 10 week intervention period, 22 week follow-up.
Change in lateral trunk flexion strength	Lateral trunk flexion strength will be measured in kg using hand-held dynamometry.	Baseline, end of 10 week intervention period, 22 week follow-up.
Change in lateral trunk flexion endurance	Trunk flexion endurance as measured by a clinical trunk curl-up test which counts the number of trunk curls a participant can perform in 1 minute.	Baseline, end of 10 week intervention period, 22 week follow-up.
Expanding Disability Status Scale	Neurological exam used to assess disability in people with multiple sclerosis. Scores range from 0 to 6 with higher scores indicating more disability.	Baseline
25 Foot Walk Test	Amount of time in seconds it takes for participant to walk 25 feet as quickly and safely as possible.	Baseline and after the 10 week intervention period.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Mark M. Manago, DPT, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Hip abduction; Trunk muscles
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 20-1527; K12HD055931 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will publish the trial results data on the ClinicalTrials.gov website, on which the clinical trial will be registered. Sharing of data will include the potential of sharing raw data generated from all clinical assessments under a data-sharing agreement.
• IPD Sharing Time Frame: We will publish the trial results within one year of testing the final participant.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No