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Examining a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis
NA trial testing Seated Physical activity INtervention for persons with MS, "SPIN" program- Intervention Condition in Multiple Sclerosis in 24 participants. Completed in 30 May 2025.
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 24 |
| Start date | 17 January 2024 |
| Primary completion | 30 May 2025 |
| Estimated completion | 30 May 2025 |
| Sites | 1 location across United States |
The University of Texas Health Science Center, Houston
18 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility of the intervention will be measured based on reaching recruitment goals (n=24) within a one-year period.
| Group | Value | 95% CI |
|---|---|---|
| All Eligible Participants | 24 |
Feasibility of the intervention will be measured based on retention of \>80% of enrolled participants for the full 16-week study period.
| Group | Value | 95% CI |
|---|---|---|
| Exercise Training Intervention | 10 | |
| Wellness Control | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Exercise Training Intervention | 1 | |
| Wellness Control | 0 |
Acceptability was assessed through semi-structured interviews conducted with participants. Positive perception was defined as participants expressing favorable views or satisfaction with the intervention. Reported is the number of participants who expressed positive perceptions during the interview.
| Group | Value | 95% CI |
|---|---|---|
| Exercise Training Intervention | 9 | |
| Wellness Control | 8 |
The post-intervention acceptability Survey total score ranges from 1 to 5, a higher score indicates greater acceptability.
| Group | Value | 95% CI |
|---|---|---|
| Exercise Training Intervention | 4.5 | ± 0.97 |
| Wellness Control | 4.56 | ± 0.53 |
Time frame: up to 16 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Exercise Training Interven… | Wellness Control |
|---|---|---|---|
| Urinary tract infection (UTI) Hospitalization | Renal and urinary disorders | — | — |
| Cognitive Hospital | Nervous system disorders | — | — |
| Back Pain Cycling | Musculoskeletal and connective tissue disorders | — | — |
| X-ray Slip Disk | Musculoskeletal and connective tissue disorders | — | — |
| Minor MS Exacerbation | Nervous system disorders | — | — |
| Hospitalization | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
Data from ClinicalTrials.gov NCT05888727 adverse events section.
The goal of this randomized controlled clinical trial is to examine the feasibility and initial efficacy of undertaking and delivering a novel, stakeholder-informed exercise training program for wheelchair users with multiple sclerosis. The main questions it aims to answer are: * Is the study feasible as measured by participant recruitment (24 participants total), retention (80%), and safety (adverse events)? * Is the study acceptable as measured by participant satisfaction and perceptions using an evaluation survey and semi-structured interviews? * Is there significant change in following the 16-week study in metabolic health outcomes, MS symptoms, and exercise behavior change? Participants will be randomized to complete the 16-week SPIN exercise training program or WellMS attention/contact wellness program. Researchers will compare the SPIN and WellMS groups to determine if there is a significant difference in metabolic health outcomes, MS symptoms, and exercise behavior change.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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