NCT06554340 Vascular Mechanisms, Functional Outcomes, & Exercise Among Persons With Multiple Sclerosis With Hypertension
| NCT ID | NCT06554340 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Massachusetts, Boston |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-04-15 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * People with additional cardiovascular comorbidities; * People with type 1 diabetes mellitus; * Physician disapproval to participating in the study; * Space constraints to fit a cycle ergometer at the home of prospective participants.
Contact & Investigator
Bo Fernhall, PhD
PRINCIPAL INVESTIGATOR
University of Massachusetts, Boston
Frequently Asked Questions
Who can join the NCT06554340 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06554340 currently recruiting?
Yes, NCT06554340 is actively recruiting participants. Contact the research team at tracy.baynard@umb.edu for enrollment information.
Where is the NCT06554340 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06554340 clinical trial?
NCT06554340 is sponsored by University of Massachusetts, Boston. The principal investigator is Bo Fernhall, PhD at University of Massachusetts, Boston. The trial plans to enroll 80 participants.
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