Multiple SclerosisSPINNCT07891520
Efficacy of Seated Physical Activity INtervention(SPIN) for Wheelchair Users With Multiple Sclerosis
A study testing SPIN exercise-training in people with Multiple Sclerosis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess changes in the outcome of exercise behavior between the SPIN exercise-training condition and the WEllness for Longevity Living (WELL) attention/contact wellness control condition and to examine differences in exercise behavior, functioning, disability, and health between the SPIN… 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?
- SPIN exercise-training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to 5 Feb 2029
- 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
- Diagnosis of multiple sclerosis (MS).
- Self-reported use of a wheelchair (manual wheelchair, power wheelchair, or scooter) ≥50% of the time.
- Relapse-free for the past 30 days.
- Godin Leisure Time Exercise Questionnaire Health Contribution Score <14 units (i.e., not meeting current physical activity guidelines).
Who cannot join
- An MS relapse within the past 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Stephanie L Silveira, PhD, (713) 500-9484, Stephanie.L.Silveira@uth.tmc.edu
Rachel Barnes, (713) 500 9464, Rachel.Barnes.1@uth.tmc.edu
About this study
Official title: Examining the Efficacy of a Home-Based Exercise Training Intervention for Wheelchair Users With Multiple Sclerosis
The purpose of this study is to assess changes in the outcome of exercise behavior between the SPIN exercise-training condition and the WEllness for Longevity Living (WELL) attention/contact wellness control condition and to examine differences in exercise behavior, functioning, disability, and health between the SPIN and WELL conditions
- Conditions
- Multiple Sclerosis
- Being tested
- SPIN exercise-training, Control Condition (WELL)
- Keywords
- exercise
- 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.
SPIN exercise-trainingBehavioural
Participants complete three days of both modalities each week, with at least one day of rest between resistance sessions. For the first two weeks, all participants begin at 10-minute aerobic sessions and 1 set of 10 repetitions of five resistance exercises. The aerobic goal is to progress to 30-minute sessions (90 minutes/week) using a cycle (arm) ergometer; the resistance goal is 2 sets of 15 repetitions of 10 exercises (~60 minutes/week). After two weeks, participants select one of three progression tracks (white, blue, or orange) with their coach. The final overall goal is 30 minutes of aerobic exercise plus 10 resistance exercises for two sets of 15 repetitions, three days per week (~150 minutes/week of MVPA).The total time is 16 weeks.
Control Condition (WELL)Behavioural
The WELL attention/contact control mirrors SPIN in coaching schedule and materials but focuses on health behaviors other than physical activity (diet, emotions, stress, sleep, fatigue, and falls). It is based on Social Cognitive Theory (SCT) principles and integrates National Multiple Sclerosis Society (NMSS) wellness resources. WELL includes 12 newsletters (Diet, Sleep, Stress, Balance, Cognition, and Fatigue).
| Study group | Role | What they receive |
|---|---|---|
| SPIN exercise-training condition | Experimental | Not described Receives: Behavioral: SPIN exercise-training |
| WELL attention/contact wellness control condition | Active comparator | Not described Receives: Behavioral: Control Condition (WELL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self reported total minutes per week of moderate-to-vigorous physical activity (MVPA)
Measured: Baseline , 16 weeks.
Change in strength training, assessed by the Leisure Time Physical Activity Questionnaire for People with Disabilities (LTPAQ-D)
Participants report the number of days and average minutes per day spent in mild-, moderate-, and vigorous-intensity aerobic activities during the previous 7 days. Weekly minutes are calculated separately for each intensity and summed to obtain total aerobic physical activity, expressed in minutes per week. Higher values indicate greater participation in leisure-time aerobic physical activity
Measured: Baseline , 16 weeks
Secondary outcomes (5)
Change in device-measured exercise behavior
Physical activity is measured using an ActiGraph GT3X+ triaxial accelerometer worn on the non-dominant wrist for 7 consecutive days. Acceleration data from the three axes are combined to derive vector magnitude activity counts. Total vector magnitude activity counts are calculated using the study-specified accelerometer data processing and aggregation methods.
Measured: Baseline , 16 weeks
Change in Upper-limb function as assessed by the Nine-Hole Peg Test
Upper-limb dexterity is assessed using the Nine-Hole Peg Test (NHPT). Participants are instructed to place nine pegs into a pegboard and remove them as quickly as possible. Performance is measured by the time required to complete the task, recorded in seconds. A decrease in completion time indicates improved manual dexterity.
Measured: Baseline , 16 weeks
Change in Upper-limb function as assessed by the Grip strength using the hand dynamometer
Grip strength is assessed using a hand dynamometer. Participants squeeze the dynamometer according to the study protocol, and grip strength is recorded in kilograms s. An increase in grip strength indicates improved grip force.
Measured: Baseline , 16 weeks
Change in Disability / Activities of Daily Living ( ADL) as assessed by the Barthel Index score
The Barthel Index will be used to assess changes in participants' independence in activities of daily living (ADLs), including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair climbing. Total scores range from 0 to 100 with higher scores indicating greater independence and lower scores indicating greater dependence.
Measured: Baseline , 16 weeks
Change in Health-Related Quality of Life as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
The Multiple Sclerosis Impact Scale-29 (MSIS-29) is a 29-item, patient-reported outcome measure that assesses the physical and psychological impact of multiple sclerosis on health-related quality of life. The scale includes 20 physical-impact items and 9 psychological-impact items. Scores are transformed to a 0-100 scale, with higher scores indicating greater impact of multiple sclerosis and worse health-related quality of life.
Measured: Baseline , 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start4 Jan 2027 (estimated)
- Primary completion2 Jan 2029 (estimated)
- Study completion5 Feb 2029 (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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Stephanie Lee Silveira, The University of Texas Health Science Center, Houston
- Investigators
- Stephanie L Silveira, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891520
- Sponsor's protocol ID
- HSC-SPH-26-0828
- Other IDs
- RG-2512-45664
- Acronym
- SPIN
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Home-Based Exercise Training Intervention for Wheelchair Users With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07891520
- Acronym / sponsor ID
- SPIN / HSC-SPH-26-0828
- Conditions
- Multiple Sclerosis
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 2 Jan 2029 (estimated)
- Study completion
- 5 Feb 2029 (estimated)
- First posted
- 23 Oct 2026 (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 purpose of this study is to assess changes in the outcome of exercise behavior between the SPIN exercise-training condition and the WEllness for Longevity Living (WELL) attention/contact wellness control condition and to examine differences in exercise behavior, functioning, disability, and health between the SPIN and WELL conditions
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPIN exercise-training condition | Experimental | Behavioral: SPIN exercise-training |
| WELL attention/contact wellness control condition | Active comparator | Behavioral: Control Condition (WELL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of multiple sclerosis (MS).
- Self-reported use of a wheelchair (manual wheelchair, power wheelchair, or scooter) ≥50% of the time.
- Relapse-free for the past 30 days.
- Godin Leisure Time Exercise Questionnaire Health Contribution Score <14 units (i.e., not meeting current physical activity guidelines).
Key exclusion criteria (1 listed)
- An MS relapse within the past 30 days
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 |
|---|---|---|
| SPIN exercise-trainingParticipants complete three days of both modalities each week, with at least one day of rest between resistance sessions. For the first two weeks, all participants begin at 10-minute aerobic sessions and 1 set of 10 repetitions of five resistance exercises. The aerobic goal is to progress to 30-minute sessions (90 minutes/week) using a cycle (arm) ergometer; the resistance goal is 2 sets of 15 repetitions of 10 exercises (~60 minutes/week). After two weeks, participants select one of three progression tracks (white, blue, or orange) with their coach. The final overall goal is 30 minutes of aerobic exercise plus 10 resistance exercises for two sets of 15 repetitions, three days per week (~150 minutes/week of MVPA).The total time is 16 weeks. | Behavioural | SPIN exercise-training condition |
| Control Condition (WELL)The WELL attention/contact control mirrors SPIN in coaching schedule and materials but focuses on health behaviors other than physical activity (diet, emotions, stress, sleep, fatigue, and falls). It is based on Social Cognitive Theory (SCT) principles and integrates National Multiple Sclerosis Society (NMSS) wellness resources. WELL includes 12 newsletters (Diet, Sleep, Stress, Balance, Cognition, and Fatigue). | Behavioural | WELL attention/contact wellness control condition |
Primary outcome
Change in self reported total minutes per week of moderate-to-vigorous physical activity (MVPA)
Time frame: Baseline , 16 weeks.
Change in strength training, assessed by the Leisure Time Physical Activity Questionnaire for People with Disabilities (LTPAQ-D)
Time frame: Baseline , 16 weeks
Participants report the number of days and average minutes per day spent in mild-, moderate-, and vigorous-intensity aerobic activities during the previous 7 days. Weekly minutes are calculated separately for each intensity and summed to obtain total aerobic physical activity, expressed in minutes per week. Higher values indicate greater participation in leisure-time aerobic physical activity
5 secondary outcomes
Change in device-measured exercise behavior
Time frame: Baseline , 16 weeks
Change in Upper-limb function as assessed by the Nine-Hole Peg Test
Time frame: Baseline , 16 weeks
Change in Upper-limb function as assessed by the Grip strength using the hand dynamometer
Time frame: Baseline , 16 weeks
Change in Disability / Activities of Daily Living ( ADL) as assessed by the Barthel Index score
Time frame: Baseline , 16 weeks
Change in Health-Related Quality of Life as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: Baseline , 16 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 23 Oct 2026.
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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.
Stephanie L Silveira, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIN exercise-training in people with Multiple Sclerosis, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Oct 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?
Contact Stephanie L Silveira, PhD ((713) 500-9484, Stephanie.L.Silveira@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self reported total minutes per week of moderate-to-vigorous physical activity (MVPA) (time frame: Baseline , 16 weeks.). The study lists 2 primary outcomes in all. 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 23 Oct 2026.