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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Boston

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Home-based aerobic training

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Home-based aerobic trainingExperimental treatment 1 intervention
Group B: Attention controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline, pre-intervention/BICAMS; Within 5 days after completion of the training intervention/BICAMS
2

Timed 25-Foot Walk

Measurement of mobility disability

Time frame
Baseline, pre-intervention/25-Foot Walk; Within 5 days after completion of training intervention/ 25-Foot Walk

Secondary outcomes

1

Blood pressure

24h Blood pressure and central systolic blood pressure

Time frame
Baseline, pre-intervention/oscillometry, applanation tonometry; Within 5 days after completion of training intervention/oscillometry, applanation tonometry
2

Flow-mediated dilation

Non-invasive measurement of endothelium-dependent vasodilation and macrovascular function

Time frame
Baseline, pre-intervention/ultrasonography; Within 5 days after completion of training intervention/ultrasonography
3

Forearm blood flow

Non-invasive measurement of microvascular function

Time frame
Baseline, pre-intervention/ strain-gauge plethysmography; Within 5 days after completion of training intervention/strain-gauge plethysmography
4

Cardiorespiratory fitness

Maximal oxygen uptake

Time frame
Baseline, pre-intervention/indirect calorimetry; Within 5 days after completion of training intervention/indirect calorimetry

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Boston

Lead sponsor

University of Illinois at Chicago

Collaborator

University of Alabama at Birmingham

Collaborator