Recruiting

Cycling vs. Stretching

Sponsor:

University of Massachusetts, Boston

Code:

NCT06554340

Conditions

Multiple Sclerosis

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home-based aerobic training

Study Details

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.

Conditions

Multiple Sclerosis

Hypertension

Study ID

NCT06554340

Start date

Apr 15, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home-based aerobic training

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.

no intervention: Attention control

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

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 outcome measure

  • Information processing speed [ Time Frame: Baseline, pre-intervention/BICAMS; Within 5 days after completion of the training intervention/BICAMS ]
  • Timed 25-Foot Walk [ Time Frame: Baseline, pre-intervention/25-Foot Walk; Within 5 days after completion of training intervention/ 25-Foot Walk ]

Central Contacts and Locations

Central contacts

Tracy Baynard, PhD

2178404493tracy.baynard@umb.edu

Joao L Maroco, MS

7738933897joao.maroco001@umb.edu

Locations

UMass Boston

Recruiting

Boston, Massachusetts, United States, 02125

More Information

Sponsor

University of Massachusetts, Boston

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Keywords

  • exercise
  • blood pressure
  • mobility
  • cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Boston on 2025-08-22.