Multiple SclerosisBIPAMS-BrainNCT04496804
Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
A study testing Behavioral Intervention for Physical Activity in MS (BIPAMS) and Wellness for MS (WellMS) in people with Multiple Sclerosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the United States. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Behavioral Intervention for Physical Activity in MS (BIPAMS) and Wellness for MS (WellMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 3 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of multiple sclerosis
- relapse free in the last 30 days
- being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months
- ambulate without assistance
- low risk for contraindications for MRI
Who cannot join
- moderate or high risk for undertaking strenuous or maximal exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35209
About this study
Official title: BIPAMS-Brain:Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the United States. This disease results in the progressive loss of walking mobility and substantial worsening of cognition, symptoms, and quality of life over time. There is evidence that physical activity is beneficially associated with aerobic fitness and brain structure and function in persons with MS. Nevertheless, this population is strikingly sedentary and physically inactive. This highlights a vital opportunity to improve aerobic fitness and brain health by developing behavioral interventions that increase physical activity. To that end, this project is a Phase-II randomized control trial for examining the efficacy of a behavioral intervention that is based on social-cognitive theory and delivered through the Internet for increasing physical activity and, secondarily, improving aerobic fitness and brain structure and function in persons with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Behavioral Intervention for Physical Activity in MS (BIPAMS), Wellness for MS (WellMS)
- Keywords
- physical activity
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention for Physical Activity in MS (BIPAMS)Behavioural
A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
Wellness for MS (WellMS)Behavioural
A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention for Physical Activity in MS (BIPAMS) | Experimental | The current behavioral intervention consists of two primary components; an Internet website and one-on-one video chats with a behavioral coach. The Internet website involves content delivered through interactive video courses. The interactive video courses are based on elements of social cognitive theory. Each courses consists of an introduction, the primary content, and a take home message. The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic. A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention, discussion of website material, supportive accountability, and reporting of adverse events/injuries. The chats are conducted face-to-face through Skype. The chats occur 7 times during the first 2 months, 4 times during the second 2 months, and twice during the final 2 months of the intervention. Receives: Behavioral: Behavioral Intervention for Physical Activity in MS (BIPAMS) |
| Wellness for MS (WellMS) | Sham comparator | Provides an Internet website and one-on-one video chats that discuss materials about self-managing multiple sclerosis (MS) consequences and health indicators through methods other than physical activity. The materials are transformations of brochures provided by the National MS Society, including Gait or Walking Problems: The Basic Facts; MS and Your Emotions; Pain: The Basic Facts; Solving Cognitive Problems; Taming Stress in MS; Food for Thought: MS and Nutrition; and Vitamins, Minerals, and Herbs: An Introduction. The delivery of the Internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition, and will have a comparable time commitment. The control condition will not involve tracking steps and a pedometer with not be provided. Receives: Behavioral: Wellness for MS (WellMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of moderate to vigorous physical activity - Baseline
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Measured: Assessment will be conducted before the intervention
Minutes of moderate to vigorous physical activity - Post intervention
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Measured: Assessment will be conducted immediately after the intervention
Secondary outcomes (10)
cardiorespiratory fitness; oxygen consumption during exercise - baseline
A graded exercise test on a treadmill. Participants will walk at a quick pace on the treadmill and the incline will increase every 2 minutes until the participant is no longer able to keep pace with the treadmill.
Measured: Assessment will be conducted before the intervention
cardiorespiratory fitness; oxygen consumption during exercise - post intervention
A graded exercise test on a treadmill. Participants will walk at a quick pace on the treadmill and the incline will increase every 2 minutes until the participant is no longer able to keep pace with the treadmill.
Measured: Assessment will be conducted immediately after the intervention
distance walked - baseline
The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping.
Measured: Assessment will be conducted before the intervention
distance walked - post-intervention
The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping.
Measured: Assessment will be conducted immediately after the intervention
information processing speed; cognitive function - baseline
The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols.
Measured: Assessment will be conducted before the intervention
information processing speed; cognitive function - post intervention
The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols.
Measured: Assessment will be conducted immediately after the intervention
volume of subcortical grey matter brain structures - baseline
An MRI will be conducted to measure brain structure.
Measured: Assessment will be conducted before the intervention
volume of subcortical grey matter brain structures - post intervention
An MRI will be conducted to measure brain structure.
Measured: Assessment will be conducted immediately after the intervention
resting state functional brain connectivity - baseline
An MRI will be conducted to measure brain function.
Measured: Assessment will be conducted before the intervention
resting state functional brain connectivity - post intervention
An MRI will be conducted to measure brain function.
Measured: Assessment will be conducted immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start2 Nov 2020
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
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.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert W Motl, University of Alabama at Birmingham
- Investigators
- Robert Motl, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496804
- Sponsor's protocol ID
- 300005111
- Acronym
- BIPAMS-Brain
- Status last verified
- Sep 2021
- First submitted
- 29 Jul 2020
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIPAMS-Brain:Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04496804
- Acronym / sponsor ID
- BIPAMS-Brain / 300005111
- Conditions
- Multiple Sclerosis
- Keywords
- physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 3 Aug 2020 (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.
Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the United States. This disease results in the progressive loss of walking mobility and substantial worsening of cognition, symptoms, and quality of life over time. There is evidence that physical activity is beneficially associated with aerobic fitness and brain structure and function in persons with MS. Nevertheless, this population is strikingly sedentary and physically inactive. This highlights a vital opportunity to improve aerobic fitness and brain health by developing behavioral interventions that increase physical activity. To that end, this project is a Phase-II randomized control trial for examining the efficacy of a behavioral intervention that is based on social-cognitive theory and delivered through the Internet for increasing physical activity and, secondarily, improving aerobic fitness and brain structure and function in persons with MS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention for Physical Activity in MS (BIPAMS) | Experimental | Behavioral: Behavioral Intervention for Physical Activity in MS (BIPAMS)The current behavioral intervention consists of two primary components; an Internet website and one-on-one video chats with a behavioral coach. The Internet website involves content delivered through interactive video courses. The interactive video courses are based on elements of social cognitive theory. Each courses consists of an introduction, the primary content, and a take home message. The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic. A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention, discussion of website material, supportive accountability, and reporting of adverse events/injuries. The chats are conducted face-to-face through Skype. The chats occur 7 times during the first 2 months, 4 times during the second 2 months, and twice during the final 2 months of the intervention. |
| Wellness for MS (WellMS) | Sham comparator | Behavioral: Wellness for MS (WellMS)Provides an Internet website and one-on-one video chats that discuss materials about self-managing multiple sclerosis (MS) consequences and health indicators through methods other than physical activity. The materials are transformations of brochures provided by the National MS Society, including Gait or Walking Problems: The Basic Facts; MS and Your Emotions; Pain: The Basic Facts; Solving Cognitive Problems; Taming Stress in MS; Food for Thought: MS and Nutrition; and Vitamins, Minerals, and Herbs: An Introduction. The delivery of the Internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition, and will have a comparable time commitment. The control condition will not involve tracking steps and a pedometer with not be provided. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of multiple sclerosis
- relapse free in the last 30 days
- being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months
- ambulate without assistance
- low risk for contraindications for MRI
Key exclusion criteria (1 listed)
- moderate or high risk for undertaking strenuous or maximal exercise
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 |
|---|---|---|
| Behavioral Intervention for Physical Activity in MS (BIPAMS)A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS. | Behavioural | Behavioral Intervention for Physical Activity in MS (BIPAMS) |
| Wellness for MS (WellMS)A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS. | Behavioural | Wellness for MS (WellMS) |
Primary outcome
Minutes of moderate to vigorous physical activity - Baseline
Time frame: Assessment will be conducted before the intervention
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Minutes of moderate to vigorous physical activity - Post intervention
Time frame: Assessment will be conducted immediately after the intervention
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
10 secondary outcomes
cardiorespiratory fitness; oxygen consumption during exercise - baseline
Time frame: Assessment will be conducted before the intervention
cardiorespiratory fitness; oxygen consumption during exercise - post intervention
Time frame: Assessment will be conducted immediately after the intervention
distance walked - baseline
Time frame: Assessment will be conducted before the intervention
distance walked - post-intervention
Time frame: Assessment will be conducted immediately after the intervention
information processing speed; cognitive function - baseline
Time frame: Assessment will be conducted before the intervention
information processing speed; cognitive function - post intervention
Time frame: Assessment will be conducted immediately after the intervention
volume of subcortical grey matter brain structures - baseline
Time frame: Assessment will be conducted before the intervention
volume of subcortical grey matter brain structures - post intervention
Time frame: Assessment will be conducted immediately after the intervention
resting state functional brain connectivity - baseline
Time frame: Assessment will be conducted before the intervention
resting state functional brain connectivity - post intervention
Time frame: Assessment will be conducted immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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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. This study is not recruiting at the moment.
Robert Motl, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention for Physical Activity in MS (BIPAMS) and Wellness for MS (WellMS) in people with Multiple Sclerosis, run by University of Alabama at Birmingham 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 4 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minutes of moderate to vigorous physical activity - Baseline (time frame: Assessment will be conducted before the intervention). 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 4 Feb 2022.