Multiple SclerosisPromPT-MSNCT06933160
Promotion of Exercise Through Physical Therapy for Multiple Sclerosis: A Pilot Study
A study testing PromPT-MS in people with Multiple Sclerosis, run by University of Michigan at 1 site in United States.
Trial summary
Physical activity and exercise help manage symptoms like fatigue in people living with multiple sclerosis (MS). Despite research supporting physical activity participation, people with MS are often insufficiently active to reach health benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PromPT-MS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of MS
- 18 years and older
- Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions
- Relapse free for the past 30 days
- Willingness to attend all study visits and PT sessions for the duration of study
- Access to a smartphone
Show all 9Show fewer
- Not sufficiently active as measured by the Godin Leisure Time Exercise Questionnaire score <24
- Patient Determined Disease Steps score 0-3 or the ability to ambulate either independently or with the use of a cane (or similar device) for at least 75% of the time at baseline
- Less than 2 affirmative on the physical activity readiness questionnaire
Who cannot join
- Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
- Unable to attend study visits
- Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promotion of Exercise for Multiple Sclerosis Through Physical Therapy (PromPT)
Physical activity and exercise help manage symptoms like fatigue in people living with multiple sclerosis (MS). Despite research supporting physical activity participation, people with MS are often insufficiently active to reach health benefits. Promotional efforts that are sustainable within the United States healthcare system are needed. This project is a pilot randomized controlled trial examining the feasibility of a consultative physical therapy intervention for increasing physical activity engagement.
Read the detailed description
Multiple sclerosis is a debilitating disease usually diagnosed between the ages of 20 and 49 years with no curative options, resulting in a focus on rehabilitation strategies to manage symptoms, restore function, and improve quality of life. Physical activity, particularly exercise training, is considered one of the best rehabilitation strategies for comprehensive multiple sclerosis management. Despite strong evidence of the safety and benefits of physical activity and exercise in this population, persons with multiple sclerosis do not engage in sufficient levels of physical activity. Physical therapists are well positioned and have the expertise to facilitate physical activity and exercise participation for persons with multiple sclerosis. However, physical therapy is underutilized, particularly in people with more mild multiple sclerosis symptoms, when the best results may be achieved. A proactive physical therapy delivery model may help persons with multiple sclerosis increase and maintain their physical activity and exercise behaviors. The proposed study involves 1) a randomized controlled trial to evaluate outcomes of feasibility in the four metrics of process, resources, management, and scientific outcomes, and 2) an assessment of the immediate and sustained treatment effect of the physical therapy model compared to a waitlist control on accelerometer-measured physical activity. The feasibility trial will be conducted with a sample of 40 persons with multiple sclerosis randomized to either the intervention or waitlist control group. Participants will complete assessments at baseline, post-intervention (6 months), and follow-up (10 months). Participants will complete a formative evaluation, including surveys and one-on-one semi-structured interviews, to assess satisfaction, acceptability, feasibility, and appropriateness of the physical therapy delivery model. The proposed feasibility study, interviews, and implementation assessments will directly lead to the submission of an R01 to test the efficacy of an appropriately powered randomized controlled trial and to identify context-specific barriers and facilitators to the successful uptake of this physical therapy model in clinical settings. The dissemination of the results of this feasibility study can lead to improvements in physical therapy delivery for persons with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- PromPT-MS
- Keywords
- multiple sclerosis, physical activity, exercise, physical therapy
- 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.
PromPT-MSBehavioural
The experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention. Receives: Behavioral: PromPT-MS |
| Waitlist Control | No intervention | 24-week waitlist control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer-measured moderate-to-vigorous physical activity
The duration (in minutes per day) of moderate-to-vigorous physical activity (MVPA) will be assessed using a waist-worn accelerometer (ActiGraph model GT3X+). Participants will wear the accelerometer attached to a belt around their waist during waking hours over a 7-day period. A greater duration of MVPA indicates a higher level of physical activity.
Measured: From enrolment to end of treatment at 24 weeks
Secondary outcomes (4)
Total physical activity
The duration (in minutes per day) of physical activity (light, moderate, and vigorous activity) will be assessed using a waist-worn accelerometer (ActiGraph model GT3X+). Participants will wear the accelerometer attached to a belt around their waist during waking hours over a 7-day period. A greater duration of physical activity indicates a higher level of physical activity.
Measured: From enrolment to end of treatment at 24 weeks
Fatigue
PROMIS Fatigue CAT
Measured: From enrolment to end of treatment at 24 weeks
Physical Function
PROMIS Physical Function CAT
Measured: From enrolment to end of treatment at 24 weeks
Exercise Self-efficacy
Exercise Self-efficacy scale
Measured: From enrolment to end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start28 Jan 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Shirley Ryan AbilityLab
- Responsible party
- Principal investigator, Dominique Kinnett-Hopkins, University of Michigan
- Investigators
- Dominique Kinnett-Hopkins, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933160
- Sponsor's protocol ID
- HUM00266361
- Other IDs
- 1R03HD111005-01A1
- Acronym
- PromPT-MS
- Status last verified
- Jun 2026
- First submitted
- 5 Apr 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Exercise for Multiple Sclerosis Through Physical Therapy (PromPT)
- ClinicalTrials.gov ID
- NCT06933160
- Acronym / sponsor ID
- PromPT-MS / HUM00266361
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, physical activity, exercise, physical therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Shirley Ryan AbilityLab
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Apr 2025 (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.
Physical activity and exercise help manage symptoms like fatigue in people living with multiple sclerosis (MS). Despite research supporting physical activity participation, people with MS are often insufficiently active to reach health benefits. Promotional efforts that are sustainable within the United States healthcare system are needed. This project is a pilot randomized controlled trial examining the feasibility of a consultative physical therapy intervention for increasing physical activity engagement.
Detailed description
Multiple sclerosis is a debilitating disease usually diagnosed between the ages of 20 and 49 years with no curative options, resulting in a focus on rehabilitation strategies to manage symptoms, restore function, and improve quality of life. Physical activity, particularly exercise training, is considered one of the best rehabilitation strategies for comprehensive multiple sclerosis management. Despite strong evidence of the safety and benefits of physical activity and exercise in this population, persons with multiple sclerosis do not engage in sufficient levels of physical activity. Physical therapists are well positioned and have the expertise to facilitate physical activity and exercise participation for persons with multiple sclerosis. However, physical therapy is underutilized, particularly in people with more mild multiple sclerosis symptoms, when the best results may be achieved. A proactive physical therapy delivery model may help persons with multiple sclerosis increase and maintain their physical activity and exercise behaviors. The proposed study involves 1) a randomized controlled trial to evaluate outcomes of feasibility in the four metrics of process, resources, management, and scientific outcomes, and 2) an assessment of the immediate and sustained treatment effect of the physical therapy model compared to a waitlist control on accelerometer-measured physical activity. The feasibility trial will be conducted with a sample of 40 persons with multiple sclerosis randomized to either the intervention or waitlist control group. Participants will complete assessments at baseline, post-intervention (6 months), and follow-up (10 months). Participants will complete a formative evaluation, including surveys and one-on-one semi-structured interviews, to assess satisfaction, acceptability, feasibility, and appropriateness of the physical therapy delivery model. The proposed feasibility study, interviews, and implementation assessments will directly lead to the submission of an R01 to test the efficacy of an appropriately powered randomized controlled trial and to identify context-specific barriers and facilitators to the successful uptake of this physical therapy model in clinical settings. The dissemination of the results of this feasibility study can lead to improvements in physical therapy delivery for persons with multiple sclerosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: PromPT-MSThe experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention. |
| Waitlist Control | No intervention | –24-week waitlist control condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of MS
- 18 years and older
- Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions
- Relapse free for the past 30 days
- Willingness to attend all study visits and PT sessions for the duration of study
Key exclusion criteria (3 listed)
- Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
- Unable to attend study visits
- Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol.
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 |
|---|---|---|
| PromPT-MSThe experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention. | Behavioural | Experimental |
Primary outcome
Accelerometer-measured moderate-to-vigorous physical activity
Time frame: From enrolment to end of treatment at 24 weeks
The duration (in minutes per day) of moderate-to-vigorous physical activity (MVPA) will be assessed using a waist-worn accelerometer (ActiGraph model GT3X+). Participants will wear the accelerometer attached to a belt around their waist during waking hours over a 7-day period. A greater duration of MVPA indicates a higher level of physical activity.
4 secondary outcomes
Total physical activity
Time frame: From enrolment to end of treatment at 24 weeks
Fatigue
Time frame: From enrolment to end of treatment at 24 weeks
Physical Function
Time frame: From enrolment to end of treatment at 24 weeks
Exercise Self-efficacy
Time frame: From enrolment to end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Dominique Kinnett-Hopkins, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PromPT-MS in people with Multiple Sclerosis, run by University of Michigan 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 9 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accelerometer-measured moderate-to-vigorous physical activity (time frame: From enrolment to end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.