Multiple SclerosisNCT06554340
Vascular Mechanisms, Functional Outcomes, & Exercise Among Persons With Multiple Sclerosis With Hypertension
A study testing Home-based aerobic training in people with Multiple Sclerosis and Hypertension, run by University of Massachusetts, Boston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Hypertension
- What is being tested?
- Home-based aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Boston
Boston, Massachusetts, 02125
About this study
Official title: Targeting Vascular Mechanisms of Functional Outcomes Via Home-based Exercise Training Among Persons With Multiple Sclerosis Who Have Hypertension
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:
Read more
- Can home-based cycling exercise training improve blood pressure by increasing blood vessel dilation in people with multiple sclerosis?
- 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.
Read the detailed description
Functionally, the disease pathophysiology of multiple sclerosis (MS) brings about a number of consequences, including cognitive dysfunction and mobility disability, which are two of the most prevalent outcomes of MS. Cognitive impairments typically occur in domains of mental processing speed and working memory and is present in 40-70% of patients with MS based on neuropsychological testing. Cognitive impairment compromises quality of life, activities of daily living, employment, and independent living in persons with MS, and co-occurs with decrements in physical abilities. Mobility disability presents as slowed walking speed and reduced walking endurance and presents in nearly 75% of persons with MS population. Cognitive dysfunction and mobility disability might be worsened through the presence of co-morbid conditions that are manageable through life-style behaviors in MS.
Hypertension is the most prevalent cardiovascular comorbidity in MS and is 25% more common in MS than the general population. Yet, there is truly a dearth of research investigating the unique and understudied population of hypertensives with MS. Importantly, hypertension produces vascular changes causing increased blood pressure (BP) pulsatility. The increased pulsatility has been associated with detrimental changes in the brain in the general population and persons with MS. The investigators have shown that BP pulsatility is inversely associated with mobility in people with MS, and that elevated BP is associated with worse cognition in MS. This suggests that mitigating hypertension and decreasing BP pulsatility through lifestyle behaviors may represent important mechanistic pathways for exerting functional adaptations in cognition and mobility for people with MS.
Physical activity and exercise training are effective approaches for improving vascular hemodynamics and BP in the general population of person with hypertension. The investigators have shown that endothelial function and arterial stiffness, which are two important mechanisms related to hypertension, are associated with physical activity in people with MS. The investigators have further shown that exercise training improves endothelial function, mobility, and cognitive function in people with MS. This suggests that exercise training may improve cognition and mobility through vascular outcomes in persons with MS who have hypertension.
The existing studies that improve cardiovascular fitness, cognitive function, and mobility in persons with MS have been center-based, directly supervised, and prescreened participants for the absence of risk factors for cardiovascular disease (CVD). This severely limits the scalability and reach of exercise interventions for managing the functional consequences of MS, and no exercise studies, to date, have targeted persons with MS who are hypertensive, thus, it is unknown if the results will transfer or work better in this group who are higher risk of CVD-related outcomes. Based on our previous randomized controlled trial (RCT) funded by the National Multiple Sclerosis Society (Grant RG4702A), The investigators are the first to successfully demonstrate that a 12-week home-based aerobic exercise intervention, coupled with internet-based monitoring and behavioral coaching, is safe and feasible among persons with MS and yielded improvements in aerobic fitness, vascular function, and mobility. However, our RCT was conducted in volunteers with MS who were prescreened for CVD risk factors (i.e., excluded persons with CVD-related comorbidities), but serves as a precursor for conducting a similar RCT in persons with cardiovascular comorbidities, such as hypertension. The proposed study aims to address this important gap and underrepresented population.
Our long-term goal involves establishing the scientific basis of home-based exercise training as a therapeutic approach for optimizing functional recovery and quality of life in persons with MS. The objective of this application will follow a RCT design and will evaluate if home-based exercise training can elicit improvements in mechanisms of hemodynamic control related to hypertension and yield clinical benefits for cognition and mobility among persons with MS who have hypertension. This would be the first of its kind RCT ever conducted in persons with MS.
Our central hypothesis is that aerobic exercise training will positively impact cognition and mobility disability (two primary outcomes) and that it will also improve cardiovascular-specific mechanisms of hypertension (secondary outcomes). Exercise training improves hypertension, and hypertension is negatively associated with cognition and mobility in older adults and persons with Alzheimer's disease. The investigators believe that a well-designed aerobic exercise training stimulus is likely to improve hypertension-related mechanisms, which will positively impact cognition and mobility disability in persons with MS, thus improving functional recovery. This central hypothesis will be addressed by pursuing two main specific aims and one exploratory specific aim via a 12-week home-based aerobic exercise training program among persons with MS who have hypertension compared with an attention-control program:
- Specific Aim 1 is to determine if the intervention improves functional outcomes related to cognition, specifically information processing speed, and mobility in hypertensives with MS. Our working hypothesis is that 12 weeks of aerobic exercise training will improve information processing speed (symbol digits modality test (SDMT) and California Verbal Learning Test-II (CVLT-II)) and attenuate mobility disability (e.g., timed 25-foot walk), which are important markers of functional outcomes.
- Specific Aim 2 will determine if vascular function and BP improve with exercise training compared with control. Our working hypothesis is that 12 weeks of aerobic exercise training will reduce BP and pulsatility, while also improving vascular-specific mechanisms related to hypertension (e.g., endothelial function and arterial stiffness).
- Specific Aim 3 is exploratory and will determine if the change in BP and vascular function can account for the change in cognition and/or mobility following exercise training. Our exploratory hypothesis is that changes in vascular function and BP will be associated with changes in cognition and walking mobility.
- Conditions
- Multiple Sclerosis, Hypertension
- Being tested
- Home-based aerobic training
- Keywords
- exercise, blood pressure, mobility, cognition
- Medical subject headings
- Multiple Sclerosis, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based aerobic trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, pre-intervention/BICAMS; Within 5 days after completion of the training intervention/BICAMS
Timed 25-Foot Walk
Measurement of mobility disability
Measured: Baseline, pre-intervention/25-Foot Walk; Within 5 days after completion of training intervention/ 25-Foot Walk
Secondary outcomes (4)
Blood pressure
24h Blood pressure and central systolic blood pressure
Measured: Baseline, pre-intervention/oscillometry, applanation tonometry; Within 5 days after completion of training intervention/oscillometry, applanation tonometry
Flow-mediated dilation
Non-invasive measurement of endothelium-dependent vasodilation and macrovascular function
Measured: Baseline, pre-intervention/ultrasonography; Within 5 days after completion of training intervention/ultrasonography
Forearm blood flow
Non-invasive measurement of microvascular function
Measured: Baseline, pre-intervention/ strain-gauge plethysmography; Within 5 days after completion of training intervention/strain-gauge plethysmography
Cardiorespiratory fitness
Maximal oxygen uptake
Measured: Baseline, pre-intervention/indirect calorimetry; Within 5 days after completion of training intervention/indirect calorimetry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start15 Apr 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Chicago, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Tracy Baynard, University of Massachusetts, Boston
- Investigators
- Bo Fernhall, PhD, Principal investigator, University of Massachusetts, BostonTracy Baynard, PhD, Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554340
- Sponsor's protocol ID
- 3616
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Vascular Mechanisms of Functional Outcomes Via Home-based Exercise Training Among Persons With Multiple Sclerosis Who Have Hypertension
- ClinicalTrials.gov ID
- NCT06554340
- Acronym / sponsor ID
- 3616
- Conditions
- Multiple Sclerosis, Hypertension
- Keywords
- exercise, blood pressure, mobility, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- University of Illinois at Chicago, University of Alabama at Birmingham
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can home-based cycling exercise training improve blood pressure by increasing blood vessel dilation in people with multiple sclerosis?
- 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.
Detailed description
Functionally, the disease pathophysiology of multiple sclerosis (MS) brings about a number of consequences, including cognitive dysfunction and mobility disability, which are two of the most prevalent outcomes of MS. Cognitive impairments typically occur in domains of mental processing speed and working memory and is present in 40-70% of patients with MS based on neuropsychological testing. Cognitive impairment compromises quality of life, activities of daily living, employment, and independent living in persons with MS, and co-occurs with decrements in physical abilities. Mobility disability presents as slowed walking speed and reduced walking endurance and presents in nearly 75% of persons with MS population. Cognitive dysfunction and mobility disability might be worsened through the presence of co-morbid conditions that are manageable through life-style behaviors in MS.
Hypertension is the most prevalent cardiovascular comorbidity in MS and is 25% more common in MS than the general population. Yet, there is truly a dearth of research investigating the unique and understudied population of hypertensives with MS. Importantly, hypertension produces vascular changes causing increased blood pressure (BP) pulsatility. The increased pulsatility has been associated with detrimental changes in the brain in the general population and persons with MS. The investigators have shown that BP pulsatility is inversely associated with mobility in people with MS, and that elevated BP is associated with worse cognition in MS. This suggests that mitigating hypertension and decreasing BP pulsatility through lifestyle behaviors may represent important mechanistic pathways for exerting functional adaptations in cognition and mobility for people with MS.
Physical activity and exercise training are effective approaches for improving vascular hemodynamics and BP in the general population of person with hypertension. The investigators have shown that endothelial function and arterial stiffness, which are two important mechanisms related to hypertension, are associated with physical activity in people with MS. The investigators have further shown that exercise training improves endothelial function, mobility, and cognitive function in people with MS. This suggests that exercise training may improve cognition and mobility through vascular outcomes in persons with MS who have hypertension.
The existing studies that improve cardiovascular fitness, cognitive function, and mobility in persons with MS have been center-based, directly supervised, and prescreened participants for the absence of risk factors for cardiovascular disease (CVD). This severely limits the scalability and reach of exercise interventions for managing the functional consequences of MS, and no exercise studies, to date, have targeted persons with MS who are hypertensive, thus, it is unknown if the results will transfer or work better in this group who are higher risk of CVD-related outcomes. Based on our previous randomized controlled trial (RCT) funded by the National Multiple Sclerosis Society (Grant RG4702A), The investigators are the first to successfully demonstrate that a 12-week home-based aerobic exercise intervention, coupled with internet-based monitoring and behavioral coaching, is safe and feasible among persons with MS and yielded improvements in aerobic fitness, vascular function, and mobility. However, our RCT was conducted in volunteers with MS who were prescreened for CVD risk factors (i.e., excluded persons with CVD-related comorbidities), but serves as a precursor for conducting a similar RCT in persons with cardiovascular comorbidities, such as hypertension. The proposed study aims to address this important gap and underrepresented population.
Our long-term goal involves establishing the scientific basis of home-based exercise training as a therapeutic approach for optimizing functional recovery and quality of life in persons with MS. The objective of this application will follow a RCT design and will evaluate if home-based exercise training can elicit improvements in mechanisms of hemodynamic control related to hypertension and yield clinical benefits for cognition and mobility among persons with MS who have hypertension. This would be the first of its kind RCT ever conducted in persons with MS.
Our central hypothesis is that aerobic exercise training will positively impact cognition and mobility disability (two primary outcomes) and that it will also improve cardiovascular-specific mechanisms of hypertension (secondary outcomes). Exercise training improves hypertension, and hypertension is negatively associated with cognition and mobility in older adults and persons with Alzheimer's disease. The investigators believe that a well-designed aerobic exercise training stimulus is likely to improve hypertension-related mechanisms, which will positively impact cognition and mobility disability in persons with MS, thus improving functional recovery. This central hypothesis will be addressed by pursuing two main specific aims and one exploratory specific aim via a 12-week home-based aerobic exercise training program among persons with MS who have hypertension compared with an attention-control program:
- Specific Aim 1 is to determine if the intervention improves functional outcomes related to cognition, specifically information processing speed, and mobility in hypertensives with MS. Our working hypothesis is that 12 weeks of aerobic exercise training will improve information processing speed (symbol digits modality test (SDMT) and California Verbal Learning Test-II (CVLT-II)) and attenuate mobility disability (e.g., timed 25-foot walk), which are important markers of functional outcomes.
- Specific Aim 2 will determine if vascular function and BP improve with exercise training compared with control. Our working hypothesis is that 12 weeks of aerobic exercise training will reduce BP and pulsatility, while also improving vascular-specific mechanisms related to hypertension (e.g., endothelial function and arterial stiffness).
- Specific Aim 3 is exploratory and will determine if the change in BP and vascular function can account for the change in cognition and/or mobility following exercise training. Our exploratory hypothesis is that changes in vascular function and BP will be associated with changes in cognition and walking mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home-based aerobic training | Experimental | Behavioral: Home-based aerobic trainingA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based aerobic trainingThe 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. | Behavioural | Home-based aerobic training |
Primary outcome
Information processing speed
Time frame: Baseline, pre-intervention/BICAMS; Within 5 days after completion of the training intervention/BICAMS
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
Time frame: Baseline, pre-intervention/25-Foot Walk; Within 5 days after completion of training intervention/ 25-Foot Walk
Measurement of mobility disability
4 secondary outcomes
Blood pressure
Time frame: Baseline, pre-intervention/oscillometry, applanation tonometry; Within 5 days after completion of training intervention/oscillometry, applanation tonometry
Flow-mediated dilation
Time frame: Baseline, pre-intervention/ultrasonography; Within 5 days after completion of training intervention/ultrasonography
Forearm blood flow
Time frame: Baseline, pre-intervention/ strain-gauge plethysmography; Within 5 days after completion of training intervention/strain-gauge plethysmography
Cardiorespiratory fitness
Time frame: Baseline, pre-intervention/indirect calorimetry; Within 5 days after completion of training intervention/indirect calorimetry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Fernhall, PhD principal investigator
University of Massachusetts, Boston
Tracy Baynard, PhD principal investigator
University of Massachusetts, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based aerobic training in people with Multiple Sclerosis and Hypertension, run by University of Massachusetts, Boston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Baynard, PhD (2178404493, tracy.baynard@umb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information processing speed (time frame: Baseline, pre-intervention/BICAMS; Within 5 days after completion of the training intervention/BICAMS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.