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

NCT05888727 | Completed Results

• 2 other identifiers: HSC-SPH-23-0719R03HD107615
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Study Feasibility: Number of Participants Recruited

  Feasibility of the intervention will be measured based on reaching recruitment goals (n=24) within a one-year period.

  16-weeks

• Study Feasibility: Number of Participants Retained

  Feasibility of the intervention will be measured based on retention of \>80% of enrolled participants for the full 16-week study period.

  16-weeks

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

  16-weeks

Secondary Outcomes (2)

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

  16-weeks

• Acceptability as Measured by the Post-intervention Acceptability Survey

  16-weeks

Other Outcomes (11)

• Change of Physical Activity Levels Through the Godin Leisure-Time Exercise Questionnaire

  16-weeks

• Change in Metabolic Health Outcomes: Triglycerides

  16-weeks

• Change in Metabolic Health Outcomes: HbA1c

  16-weeks

Study Arms (2)

Exercise Training Intervention

EXPERIMENTAL

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

Wellness Control

ACTIVE COMPARATOR

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

Interventions

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

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.

Exercise Training Intervention

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

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.

Wellness Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: collaborator
• Craig Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Silveira SL, Motl RW, Froehlich-Grobe K, Kay M. Feasibility, acceptability, and initial efficacy of a wheelchair exercise training program in persons with multiple sclerosis: study protocol for a parallel group randomized controlled trial. Disabil Rehabil Assist Technol. 2024 Nov;19(8):2998-3005. doi: 10.1080/17483107.2024.2332322. Epub 2024 Mar 22.

  PMID: 38520055 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Health

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Results Point of Contact

• Title: Stephanie L Silveira, PhD
• Organization: The University of Texas Health Science Center at Houston

Stephanie.L.Silveira@uth.tmc.edu

713-500-9000

Study Officials

• Stephanie L Silveira, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 5, 2023
• Study Start: January 17, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)