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

NCT06554340 | Recruiting

• 1 other identifier: 3616
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Multiple Sclerosis; Hypertension

Keywords

exercise; blood pressure; mobility; cognition

Outcome Measures

Primary Outcomes (2)

• 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)

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

• Timed 25-Foot Walk

  Measurement of mobility disability

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

Secondary Outcomes (4)

• Blood pressure

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

• Flow-mediated dilation

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

• Forearm blood flow

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

• Cardiorespiratory fitness

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

Study Arms (2)

Home-based aerobic training

EXPERIMENTAL

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.

Behavioral: Home-based aerobic training

Attention control

NO INTERVENTION

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.

Interventions

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.

Home-based aerobic training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Boston: lead
• University of Illinois at Chicago: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

UMass Boston

Boston, Massachusetts, 02125, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Bo Fernhall, PhD

  University of Massachusetts, Boston

  PRINCIPAL INVESTIGATOR

• Tracy Baynard, PhD

  University of Massachusetts, Boston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy Baynard, PhD

CONTACT

2178404493; tracy.baynard@umb.edu

Joao L Maroco, MS

CONTACT

7738933897; joao.maroco001@umb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Assoc Vice Provost, Grad Edu

Model Details: The proposed study will use a two-arm RCT design to examine the effect of a home-based exercise training program versus an attention control condition on markers of functional recovery, cognition and mobility disability, in persons with MS with hypertension. The primary outcomes will be cognitive performance via the BICAMS battery and mobility disability via the timed 25-foot walk, with secondary effects designed to understand the potential mechanistic role of BP, arterial stiffness, and endothelial function on functional recovery in response to the intervention.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)