Feasibility and Initial Efficacy of a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT05888727

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Seated Physical activity INtervention for persons with MS, "SPIN" program- Intervention Condition

Compared with

  • WEllness for Longevity Living with MS (WELL)- Control Condition

Results by group

Study Feasibility: Number of Participants Recruited

16-weeks

GroupValueIntervalNumber analysed
All Eligible Participants24 Participants24

Study Feasibility: Number of Participants Retained

16-weeks

GroupValueIntervalNumber analysed
Exercise Training Intervention10 Participants12
Wellness Control10 Participants11

Exercise Training Intervention

10

Wellness Control

10

Study Feasibility: Number of Participants With Study-Related Adverse Events

16-weeks

GroupValueIntervalNumber analysed
Exercise Training Intervention1 Participants12
Wellness Control0 Participants11

Exercise Training Intervention

1

Wellness Control

0

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Exercise Training Intervention120 (0.0%)0
Wellness Control110 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Study Feasibility: Number of Participants Recruited

    16-weeks

    Feasibility
  • Study Feasibility: Number of Participants Retained

    16-weeks

    Feasibility
  • Study Feasibility: Number of Participants With Study-Related Adverse Events

    16-weeks

    SafetyFeasibility

Other measures (2)

  • Acceptability: Number of Participants With Positive Perceptions During Semi-Structured Interview

    16-weeks

    Quality of life (reported by participants)Feasibility
  • Acceptability as Measured by the Post-intervention Acceptability Survey

    16-weeks

    Feasibility

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* diagnosis of MS * self-reported use of a wheelchair (i.e., manual wheelchair, power wheelchair, or scooter) >50% of the time * age of 18 years or older * relapse free for the past 30 days * being non-active defined as not engaging in regular physical activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months (i.e., not meeting current physical activity guidelines for MS)

Exclusion criteria

* during telephone screening participants will complete an exercise pre-participation health screen and if participants report any symptoms or conditions contradictive of exercise then physician clearance will be required before enrollment

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jan 2024

    2. Main results due

      May 2025

    3. Finished

      May 2025

    4. Results posted

      Jan 2026

    Assembled by software from public sources.