Clinical trial NCT04548154: Proximal Resistance Training for People With Multiple Sclerosis
Official title: Proximal Resistance Training to Improve Walking Capacity and Physical Activity in People With Multiple Sclerosis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exercise
Hip abduction
Trunk muscles
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institutes of Health (NIH)
First posted: 2020-09-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

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

Primary outcomes:
measure: Change in 6-minute walk test
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
Secondary outcomes:
measure: Change in average daily step count
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Change in movement patterns
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Change in Multiple Sclerosis Walking Scale-12
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Change in Multiple Sclerosis Self-Efficacy Score
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Change in Exercise Self-Efficacy Scale
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Change in Exercise Stages of Change category
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Change in Modified Fatigue Impact Scale
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
Other outcomes:
measure: Change in Patient-Specific Functional Scale
timeFrame: Baseline and end of 10 week intervention period.
measure: Change in hip abduction strength
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Change in lateral trunk flexion strength
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Change in lateral trunk flexion endurance
timeFrame: Baseline, end of 10 week intervention period, 22 week follow-up.
measure: Expanding Disability Status Scale
timeFrame: Baseline
measure: 25 Foot Walk Test
timeFrame: Baseline and after the 10 week intervention period.
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Mark M. Manago, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: