About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Home-based aerobic training
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Information processing speed
The Brief International Cognitive Assessment (BICAMS) battery tests, including the Symbol Digit Modalities Test (SDMT) and California Verbal Learning Test-II (CVLT-II)
Timed 25-Foot Walk
Measurement of mobility disability
Secondary outcomes
Blood pressure
24h Blood pressure and central systolic blood pressure
Flow-mediated dilation
Non-invasive measurement of endothelium-dependent vasodilation and macrovascular function
Forearm blood flow
Non-invasive measurement of microvascular function
Cardiorespiratory fitness
Maximal oxygen uptake
Sponsors and contacts
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University of Massachusetts, Boston
Lead sponsor
University of Illinois at Chicago
Collaborator
University of Alabama at Birmingham
Collaborator