Proximal Resistance Training for People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— PT-MS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548154
• Other study ID #: 20-1527
• Secondary ID: K12HD055931
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	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)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.