Targeting Vascular Mechanisms of Functional Outcomes Via Home-based Exercise Training Among Persons With Multiple Sclerosis Who Have Hypertension

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to determine if 12 weeks of cycling exercise training at home will improve three parameters: 1) blood pressure, 2) cognition, and 3) walking ability among persons with multiple sclerosis who have high blood pressure, when compared to a group that engages in a 12-week home-based stretching program. The main questions this study aims to answer are: 1. Can home-based cycling exercise training improve blood pressure by increasing blood vessel dilation in people with multiple sclerosis? 2. Can cycling exercise training improve cognition and walking mobility in people with multiple sclerosis by improving blood pressure? The investigators will compare home-based cycling training to stretching to see if cycling training improves cognition, walking mobility, blood pressure, and fitness in people with multiple sclerosis. Participation in this study will take 13-14 weeks, with participants being randomized (like flipping a coin, a 50-50 chance of being in either group) to the home-based cycling training or the stretching group. All participants will be asked to * Visit the laboratory two times, one before the beginning of the intervention (home-base training and stretching group) and one at the end of the intervention. * During visits, participants will complete tests related to cognition, walking mobility, blood pressure and fitness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Persons with confirmed multiple sclerosis diagnosis with Expanded Disability Status Scale scores of 4-6.5, characteristic of 2nd stage of multiple sclerosis;

• Hypertension defined as elevated, or Stage 1 or 2, as per the 2017 American Heart Association guidelines (brachial systolic blood pressure \> 120 mmHg or brachial diastolic blood pressure \> 80 mmHg)

• Persons who are physically inactive (less than 60 min/wk of physical activity);

• Persons with body mass index \< 40 kg/m2;

• Persons who are not confined to a wheel chair;

• Multiple sclerosis relapse in the past 30 days;

• People with stable pharmacotherapy.

Locations
United States
Massachusetts
UMass Boston
RECRUITING
Boston
Contact Information
Primary
Tracy Baynard, PhD
tracy.baynard@umb.edu
2178404493
Backup
Joao L Maroco, MS
joao.maroco001@umb.edu
7738933897
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2027-08
Participants
Target number of participants: 80
Treatments
Experimental: Home-based aerobic training
A 3-month home-based exercise training intervention comprising cycle ergometry as an aerobic mode of training coupled with behavioral coaching. The regimen will be delivered 3-4 days per week.
No_intervention: Attention control
The alternative treatment condition comprises a stretching program with minimal exercise and attention control. This program will be delivered using the same frequency and duration as the intervention. The first session will be conducted under the supervision of visiting study personnel as described above. The stretching exercises will follow the manual provided by the National Multiple Sclerosis Society and the investigators will progressively include more exercises and sets over the 3 months, this too has been standardized and manualized for reproducibility. The investigators will provide the same materials and Internet coaching for the attention control group as for the intervention group but focused on stretching and not on increasing aerobic exercise. The investigators will ask that participants not undertake additional exercise during the study duration and this will be documented through an exercise history, the Godin Leisure-Time Exercise Questionnaire.
Related Therapeutic Areas
Sponsors
Leads: University of Massachusetts, Boston
Collaborators: University of Alabama at Birmingham, University of Illinois at Chicago

This content was sourced from clinicaltrials.gov