Home-based Aerobic Training for Multiple Sclerosis

Overseen By Tracy Baynard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Boston

Disqualifiers: Cardiovascular comorbidities, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether home-based aerobic training, specifically cycling exercises, can benefit people with multiple sclerosis (MS) who also have high blood pressure. Researchers aim to determine if 12 weeks of cycling can improve blood pressure, cognitive function, and walking ability more effectively than a simple home stretching routine. Participants will be divided into two groups: one will perform cycling exercises, and the other will engage in stretching exercises. This trial suits individuals with MS who have high blood pressure, are not very active, and can walk without a wheelchair. As an unphased trial, it offers a unique opportunity to enhance understanding of how home-based exercise can benefit people with MS and high blood pressure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should have stable pharmacotherapy (consistent medication use). It's best to discuss your specific medications with the trial organizers.

What prior data suggests that home-based aerobic training is safe for people with multiple sclerosis?

Research has shown that aerobic exercise at home is safe for people with multiple sclerosis (MS). Studies have found that this exercise does not increase the risk of MS relapses or cause serious side effects. Participants in these studies exercised 2-7 times a week and found it both doable and beneficial. Another study confirmed that exercise did not cause more negative effects than other activities. Overall, exercise is considered safe and can offer health benefits for people with MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about home-based aerobic training for multiple sclerosis (MS) because it offers a unique blend of exercise and behavioral coaching right from the comfort of a participant's home. Unlike typical MS treatments that often involve medication with potential side effects, this approach focuses on enhancing physical activity through a structured cycling regimen, potentially improving mobility and quality of life without the need for frequent hospital visits. The integration of behavioral coaching helps participants stay motivated and adhere to the exercise routine, making it a promising alternative or complement to existing therapies.

What evidence suggests that home-based aerobic training is effective for improving blood pressure, cognition, and walking ability in people with multiple sclerosis?

Research has shown that aerobic exercise can benefit people with multiple sclerosis (MS). This trial will have participants engage in home-based aerobic training, including cycling, to assess its impact on movement and quality of life. Studies have found that regular home exercise can enhance mobility and overall quality of life. For those with MS, aerobic exercise has been linked to improved blood flow, which can help manage high blood pressure. It has also improved cognitive skills, such as attention and memory, in people with advanced MS. Additionally, aerobic activities are generally safe and feasible, even for those with more severe disabilities. ^{1 4 6 7 8}

Who Is on the Research Team?

Bo Fernhall, PhD

Principal Investigator

University of Massachusetts, Boston

Tracy Baynard, PhD

Principal Investigator

University of Massachusetts, Boston

Are You a Good Fit for This Trial?

This trial is for people with multiple sclerosis who can walk but not very well, have high blood pressure, and don't exercise much. They should be somewhat overweight but not extremely (BMI < 40), haven't had an MS flare-up in the last month, and their medication hasn't changed recently.

Inclusion Criteria

I have had a multiple sclerosis flare-up in the last 30 days.

I have high blood pressure according to the 2017 AHA guidelines.

I do less than 60 minutes of physical activity per week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo a 12-week home-based exercise training program, either cycling or stretching, with behavioral coaching

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in blood pressure, cognition, and mobility after the intervention

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Home-based aerobic training

Trial Overview The study tests if a 12-week home-based cycling program can lower blood pressure, improve thinking skills, and help with walking compared to a group doing stretching exercises. Participants will be randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: Home-based aerobic training Experimental Treatment 1 Intervention

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.

Group II: Attention control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Massachusetts, Boston

Lead Sponsor

Trials

42

Recruited

17,800+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11096857/

Intensive Aerobic Cycling Is Feasible and Elicits ... Aerobic exercise is feasible for individuals with MS, although those with increased disability may require novel paradigms such as FE to achieve targeted ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34343867/

Home-Based Exercise Training in Multiple Sclerosis Home-based ET, 2-7 times per week, is beneficial, feasible, and safe in people with MS. Nevertheless, there were notable limitations.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01824550

Home Exercise Intervention in Persons With Multiple ... The objective of this study is to determine the effect of home-based, aerobic exercise training on subclinical atherosclerosis and mobility disability in ...

4. researchgate.net researchgate.net/publication/375936743_Effect_of_Home-Based_Aerobic_Exercise_Training_on_Quality_of_Life_in_Multiple_Sclerosis

Effect of Home‐Based Aerobic Exercise Training on Quality ... Effect of Twelve weeks Pilates training on functional balance of male patients with Multiple Sclerosis: Randomized controlled trial. Article.

5. ijmsc.org ijmsc.org/view/aerobic-exercise-advanced-multiple-sclerosis

Feasibility of Aerobic Exercise in People With Advanced ... Acute aerobic exercise improved selective attention and executive control and was enjoyed overall by individuals with advanced MS, despite ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637110/

Safety of exercise training in multiple sclerosis - PubMed Central In studies that reported safety outcomes, there was no higher risk of relapse, AE, adverse effects or SAE for exercise training than the comparator.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002696

Implementing changing behaviour towards aerobic and ... This four-month, randomised, phase one clinical trial assessed the feasibility and safety of a home-based exercise training program delivered remotely online by ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034825003657

Exercise Training in Multiple Sclerosis: Preparing for ... Exercise training is safe and offers significant health-related benefits for people with multiple sclerosis (MS), yet participation in this health behavior is ...