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Behavioral Intervention for Multiple Sclerosis (BIPAMS Trial)
N/A
Waitlist Available
Led By Robert W Motl, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of MS
Ability to ambulate with or without assistance (i.e. walking with or without a cane or walker, but not a wheelchair)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 12 months
Awards & highlights
BIPAMS Trial Summary
This trial will test whether a 6-month behavioral intervention, delivered online, can help people with MS increase their physical activity and improve their mobility, cognition, symptoms, and quality of life.
Who is the study for?
This trial is for adults aged 18-64 with Multiple Sclerosis who are not currently active, can walk with or without assistance, and have been relapse-free for the last 30 days. Participants must have internet access, be willing to complete questionnaires and wear an accelerometer. Those at moderate/high risk for strenuous exercise or more than one 'yes' on the PAR-Q are excluded.Check my eligibility
What is being tested?
The study tests a 6-month online behavioral intervention (BIPAMS) aimed at increasing physical activity against a control condition (WELLMS). It will also assess improvements in mobility, cognition, symptoms and quality of life due to increased physical activity facilitated by changes in self-efficacy and goal setting.See study design
What are the potential side effects?
Since this is a behavioral intervention focusing on increasing physical activity through internet-based programs rather than medication or invasive procedures, significant side effects are not anticipated. However, participants may experience typical exercise-related discomfort.
BIPAMS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple sclerosis (MS).
Select...
I can walk with or without help from a cane or walker.
Select...
I am between 18 and 64 years old.
BIPAMS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of Physical Activity levels through Accelerometery from baseline at 6 and 12 months.
Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline at 6 and 12 months.
Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline at 6 and 12 months.
Secondary outcome measures
Change of self-report measures of Anxiety and Depression through the Hospital Anxiety and Depression Scale at 6 months and 12 months from baseline.
Change of self-report measures of Cognition through the Multiple Sclerosis Neuropsychological Questionnaire from baseline at 6 and 12 months.
Change of self-report measures of Cognition through the Perceived Deficits Questionnaire from baseline at 6 and 12 months.
+8 moreOther outcome measures
Changes of self-report measures based on Social Cognitive Theory on Self-Efficacy through the Exercise Self-Efficacy Scale at 6 and 12 months from baseline.
Changes of self-report measures based on Social Cognitive Theory on Self-Efficacy through the MS Self-Efficacy Sale at 6 and 12 months from baseline.
Changes of self-report measures based on goal setting through the Exercise Goal Setting and Planning Scale at 6 and 12 months from baseline.
+3 moreBIPAMS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BIPAMSExperimental Treatment1 Intervention
The behavioral intervention consists of two primary components, a dedicated Internet website and one-on-one video chats with a behavioral coach via Skype. The behavioral intervention focuses on the skills, techniques, resources, and strategies for becoming and staying physically active with MS, but it does not provide a prescription for exercise or physical activity itself.
Group II: WELLMSActive Control1 Intervention
The control condition provides an Internet website and one-on-one video chats that discuss materials about self-managing MS consequences and health indicators through methods other than physical activity.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,589 Previous Clinical Trials
2,280,074 Total Patients Enrolled
37 Trials studying Multiple Sclerosis
45,003 Patients Enrolled for Multiple Sclerosis
National Multiple Sclerosis SocietyOTHER
95 Previous Clinical Trials
9,203 Total Patients Enrolled
93 Trials studying Multiple Sclerosis
8,849 Patients Enrolled for Multiple Sclerosis
Robert W Motl, PhDPrincipal InvestigatorProfessor
7 Previous Clinical Trials
591 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
591 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with multiple sclerosis (MS).I am willing to fill out questionnaires, wear a tracking device, and be randomly assigned to a treatment group.I have not had a relapse in the last 30 days.You do not engage in regular physical activity for at least 30 minutes on more than 2 days per week in the last six months.I can walk with or without help from a cane or walker.I am between 18 and 64 years old.If you answer "yes" to more than one question on the PAR-Q, you may be at moderate or high risk for strenuous exercise and won't be able to participate in the study. If you answer "yes" to only one question, you may be at low risk and can participate.
Research Study Groups:
This trial has the following groups:- Group 1: BIPAMS
- Group 2: WELLMS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I enroll in this medical study?
"This experiment seeks 280 participants with multiple sclerosis between the ages of 18-64. Necessary qualifications include: 30 days free from relapse, access to internet and email, agreement to complete questionnaires, wear an accelerometer, participate in randomization processes; 2 or fewer days per week engaging in regular activity over the previous 6 months; capacity for ambulation without a wheelchair; aged 18-64 years old."
Answered by AI
Is senior participation encouraged in this clinical trial?
"This clinical trial has set the age of admission between 18 and 64 years old. Alternatively, there are separate trials for minors (up to 44) or seniors (392)."
Answered by AI
Are there still open slots for this trial?
"This trial, as evidenced on clinicaltrials.gov, is not presently in need of participants; the study was initially published March 1st 2018 and amended April 28th 2022. That being said, there are 550 other medical experiments currently accepting volunteers for enrollment."
Answered by AI
What objectives is this experiment attempting to fulfill?
"This clinical trial will observe the Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire between baseline and 12 months as its primary outcome. As secondary objectives, it will track a Change of self-report measures of Walking through the Patient Determined Disease Steps Scale, Changes of self-report measures of walking with Multiple sclerosis Walking Scale -12, and Changes in Sleep Quality Index at 6 and 12 months from Baseline."
Answered by AI
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