Examining a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis

Summary

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.

Conditions

• Multiple Sclerosis

Interventions

BEHAVIORAL

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

The proposed exercise training program is based on Social Cognitive Theory (SCT) for promoting aerobic and strength training in wheelchair users with MS. The 16-week program includes one-on-one video chats with a behavioral coach and various "tracks" for progressive increases in both strength and aerobic training. The proposed strength training includes 15 exercises with step-by-step instructions using resistance bands and/or wrist weights that were adapted for seated body-position that can be executed in a wheelchair. The proposed aerobic training is arm cycle ergometry; this is a low-cost and modifiable option that fits the needs of both power and manual wheelchair users. Other proposed equipment includes a comprehensive Training Manual, fitness tracker for use during exercise training sessions, and Rate of Perceived Exertion (RPE) scale for guiding individualized exercise intensity. The research team created 12 Newsletters that align with 12 proposed coaching calls.

BEHAVIORAL

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

The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.

Sponsors & Collaborators

• University of Illinois at Chicago

  collaborator OTHER

• Craig Hospital

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Stephanie L Silveira, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-17

Primary Completion

2025-05-30

Completion

2025-05-30

Countries

• United States

Study Locations