Multiple SclerosisPT-MSNCT04548154
Proximal Resistance Training for People With Multiple Sclerosis
A study testing Proximal Resistance Training in people with Multiple Sclerosis, run by University of Colorado, Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Proximal Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Proximal Resistance Training
- Keywords
- Exercise, Hip abduction, Trunk muscles
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Resistance TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Proximal Resistance Training | Experimental | 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. Receives: Other: Proximal Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, end of 10 week intervention period, 22 week follow-up.
Secondary outcomes (7)
Change in average daily step count
Step count will be measured by waist-mounted ActiGraph accelerometer-based activity monitors
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Baseline, end of 10 week intervention period, 22 week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start12 Oct 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Mark M. Manago, DPT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548154
- Sponsor's protocol ID
- 20-1527
- Other IDs
- K12HD055931
- Acronym
- PT-MS
- Status last verified
- Apr 2025
- First submitted
- 8 Sep 2020
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Manago MM, Cohen ET, Cameron MH, Christiansen CL, Bade M. Reliability, Validity, and Responsiveness of the Patient-Specific Functional Scale for Measuring Mobility-Related Goals in People With Multiple Sclerosis. J Neurol Phys Ther. 2023 Jul 1;47(3):139-145. doi: 10.1097/NPT.0000000000000439. Epub 2023 Mar 7.
PubMed 36897202
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Resistance Training to Improve Walking Capacity and Physical Activity in People With Multiple Sclerosis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04548154
- Acronym / sponsor ID
- PT-MS / 20-1527
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise, Hip abduction, Trunk muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal Resistance Training | Experimental | Other: Proximal Resistance TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal Resistance TrainingParticipants 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. | Other | Proximal Resistance Training |
Primary outcome
Change in 6-minute walk test
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
7 secondary outcomes
Change in average daily step count
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Change in movement patterns
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Multiple Sclerosis Walking Scale-12
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Multiple Sclerosis Self-Efficacy Score
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Exercise Self-Efficacy Scale
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Exercise Stages of Change category
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Change in Modified Fatigue Impact Scale
Time frame: Baseline, end of 10 week intervention period, 22 week follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Derived from this study: PubMed 36897202Manago MM, Cohen ET, Cameron MH, Christiansen CL, Bade M. Reliability, Validity, and Responsiveness of the Patient-Specific Functional Scale for Measuring Mobility-Related Goals in People With Multiple Sclerosis. J Neurol Phys Ther. 2023 Jul 1;47(3):139-145. doi: 10.1097/NPT.0000000000000439. Epub 2023 Mar 7.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark M. Manago, DPT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal Resistance Training in people with Multiple Sclerosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk test (time frame: Baseline, end of 10 week intervention period, 22 week follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04548154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.