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Online Physical Activity Program for Multiple Sclerosis (BIPAMS-Cog Trial)

N/A
Recruiting
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
Able to ambulate without assistance (self-report and PDDS)
Between 18+ years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes in fatigue from baseline, 6-months, and 12-months
Awards & highlights

BIPAMS-Cog Trial Summary

This trial will test if an Internet-delivered physical activity intervention can improve cognitive processing speed, learning and memory, symptoms, and quality of life in MS patients.

Who is the study for?
This trial is for adults in the U.S. with Multiple Sclerosis who are physically inactive, can walk without help, and have had no MS relapses in the last 30 days. Participants must speak English, have internet access, be willing to answer questionnaires, wear an accelerometer device, and accept random assignment to one of two intervention groups.Check my eligibility
What is being tested?
The study tests two online interventions aimed at improving cognitive processing speed (CPS) in people with mild MS-related walking difficulties: a physical activity program called BIPAMS and a wellness education program known as WellMS. The main goal is to see if these programs can also improve memory, reduce symptoms like fatigue and pain, and enhance quality of life.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions focused on physical activity and wellness education delivered via the Internet rather than medication or invasive procedures, side effects may include typical exercise-related discomforts such as muscle soreness or strain.

BIPAMS-Cog Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk by myself without help.
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I am 18 years old or older.
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I am willing to fill out the questionnaires.
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I am willing to wear an activity tracking device.
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I have been diagnosed with multiple sclerosis (MS).
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I have not had a relapse in the last 30 days.

BIPAMS-Cog Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes in fatigue from baseline, 6-months, and 12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in fatigue from baseline, 6-months, and 12-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognition
Secondary outcome measures
Anxiety
Depressive Symptoms
Fatigue Impact
+2 more
Other outcome measures
Accelerometry

BIPAMS-Cog Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Behavioral Intervention for Physical Activity in MS (BIPAMS)Experimental Treatment1 Intervention
The current behavioral intervention consists of two primary components; an internet website and oneonone 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 course 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 facetoface through an online videoconferencing platform.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.
Group II: Wellness for MS (WellMS)Placebo Group1 Intervention
Provides an internet website and oneonone 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention for Physical Activity in MS (BIPAMS)
2020
N/A
~30

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,268,731 Total Patients Enrolled
37 Trials studying Multiple Sclerosis
45,003 Patients Enrolled for Multiple Sclerosis
University of Illinois at ChicagoLead Sponsor
603 Previous Clinical Trials
1,558,271 Total Patients Enrolled
11 Trials studying Multiple Sclerosis
1,256 Patients Enrolled for Multiple Sclerosis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,660,200 Total Patients Enrolled
18 Trials studying Multiple Sclerosis
1,528 Patients Enrolled for Multiple Sclerosis

Media Library

Wellness for MS (WellMS) Clinical Trial Eligibility Overview. Trial Name: NCT04518657 — N/A
Multiple Sclerosis Research Study Groups: Wellness for MS (WellMS), Behavioral Intervention for Physical Activity in MS (BIPAMS)
Multiple Sclerosis Clinical Trial 2023: Wellness for MS (WellMS) Highlights & Side Effects. Trial Name: NCT04518657 — N/A
Wellness for MS (WellMS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04518657 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects have enrolled in this clinical investigation?

"Affirmative. Clinicaltrials.gov reveals that this experiment, which was originally posted on March 1st 2023, is actively enlisting volunteers. The objective is to secure 280 individuals from one clinical institution."

Answered by AI

Is there still capacity for enrolment in this clinical trial?

"Affirmative. Evidence posted on clinicaltrials.gov demonstrates that the trial initially published on March 1st 2023 is currently recruiting subjects, with a total of 280 participants sought from one centre. The listing was last updated on April 4th 2023."

Answered by AI
~103 spots leftby Oct 2024