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Vascular Mechanisms, Functional Outcomes, & Exercise Among Persons With Multiple Sclerosis With Hypertension

ClinicalTrials.gov IDNCT06554340

PhaseNA

Enrollment80

SponsorUniversity of Massachusetts, Boston

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Multiple Sclerosis, Hypertension

About this study

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.

Interventions

Behavioral: Home-based aerobic training — The aerobic training will focus on large, dynamic movements of the lower extremities using leg cycling ergometry on an upright cycle ergometer installed in the participant's homes and will progress in duration (10-40 minutes) and intensity (50-70% VO2 peak) over the 3-month intervention period. All participants will start exercise at 50% of VO2peak for 10-min as determined by the exercise test, for the first week, to individualize the exercise prescription. Progression will initially target duration with weekly progressions of 5 min to 30 min of exercise, followed by progression of intensity by 5% per week until 70% is attained, based on patient tolerance of the increased work.

Primary outcomes

Information processing speed (Baseline, pre-intervention/BICAMS; Within 5 days after completion of the training intervention/BICAMS)
Timed 25-Foot Walk (Baseline, pre-intervention/25-Foot Walk; Within 5 days after completion of training intervention/ 25-Foot Walk)

Eligibility information

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.

Study locations

UMass Boston, Boston, Massachusetts 02125 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.