Multiple Sclerosis Clinical Trial

Proximal Resistance Training for People With Multiple Sclerosis

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).

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Full 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.

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Eligibility Criteria

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 is for people with:

Multiple Sclerosis

Estimated Enrollment:

34

Study ID:

NCT04548154

Recruitment Status:

Completed

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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University of Colorado
Aurora Colorado, 80045, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

34

Study ID:

NCT04548154

Recruitment Status:

Completed

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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