University of Colorado
Aurora, Colorado, 80045, United States
NCT Number: NCT04548154
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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Notify Me18 year–64 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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Exclusion criteria
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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.
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
The 6MWT assesses walking endurance via the maximal distance an individual is able to walk in 6 minutes, reported in meters
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Step count will be measured by waist-mounted ActiGraph accelerometer-based activity monitors
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
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.
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
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.
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
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.
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
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.
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
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".
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
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.
Time frame: Baseline and end of 10 week intervention period.
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.
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Hip abduction strength will be measured in kg using hand-held dynamometry.
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Lateral trunk flexion strength will be measured in kg using hand-held dynamometry.
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
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.
Time frame: Baseline
Neurological exam used to assess disability in people with multiple sclerosis. Scores range from 0 to 6 with higher scores indicating more disability.
Time frame: Baseline and after the 10 week intervention period.
Amount of time in seconds it takes for participant to walk 25 feet as quickly and safely as possible.
University of Colorado, Denver
Other
Proximal Resistance Training to Improve Walking Capacity and Physical Activity in People With Multiple Sclerosis: A Feasibility Study
Acronym: PT-MS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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