Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490240
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Robert W Motl, University of Alabama at Birmingham

Brief Summary:
This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: BIPAMS Behavioral: WELLMS Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The investigators will advertise the study as comparing two approaches delivered through the Internet for managing consequences of MS and improving health indicators. On randomization, the investigators will again reaffirm this position with the participant. The participant will not be informed about which condition is the control or the intervention.
Primary Purpose: Other
Official Title: Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIPAMS
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.
Behavioral: BIPAMS

The primary content of the website is delivered through interactive video courses. The interactive video courses are released seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.

Another key part of the website is the Tracker feature. This feature allows for tracking of daily step counts (via Yamax SW-200 pedometer) as well as setting goals and monitoring progress over the program.

The one-on-one video chats are conducted face to face through skype and are semi-scripted. The chats consist of an ongoing review of goal-setting and progress toward goal attainment through Tracker as well as discussion of strategies and facilitators of behavioral change based on SCT and current website content. The chats occur seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.


Active Comparator: WELLMS
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.
Behavioral: WELLMS
The control condition focuses on self-managing MS through means other than physical activity. The materials are transformations of brochures provided by the NMSS, 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 account for attention and social contact as well as other possible biases such as initial reactivity and time spent on the website and video chats. The participants in the control condition will not be offered the behavioral intervention for increasing physical activity after completion of the study procedures.




Primary Outcome Measures :
  1. Change of Physical Activity levels through Accelerometery from baseline at 6 and 12 months. [ Time Frame: Baseline through 12 months ]
    Physical activity will be assessed using an ActiGraph accelerometer. Participants will wear an accelerometer on a belt around their waist during the waking hours of a 7 day period. Participants will complete this at baseline, 6 months, and 12 months.

  2. Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline at 6 and 12 months. [ Time Frame: Baseline through 12 months. ]
    Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline, 6 months, and 12 months.

  3. Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline at 6 and 12 months. [ Time Frame: Baseline through 12 months. ]
    Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline, 6 months, and 12 months.


Secondary Outcome Measures :
  1. Change of self-report measures of walking through the Multiple Sclerosis Walking Scale - 12 from baseline at 6 and 12 months [ Time Frame: Baseline through 12 months ]
    Self report measures of walking will be assessed through the Multiple Sclerosis Walking Scale - 12. Participants will complete this questionnaire at baseline, 6 month, and 12 months.

  2. Change of self-report measures of Walking through the Patient Determined Disease Steps Scale from baseline at 6 and 12 months. [ Time Frame: Baseline through 12 months ]
    Self report measures of walking will be assessed through the Patient Determined Disease Steps Scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months.

  3. Change of self-report measures of Cognition through the Perceived Deficits Questionnaire from baseline at 6 and 12 months. [ Time Frame: Baseline through 12 months ]
    Self report measures of cognition will be assessed through the Perceived Deficits Questionnaire. Participants will complete this questionnaire at baseline, 6 month, and 12 months.

  4. Change of self-report measures of Cognition through the Multiple Sclerosis Neuropsychological Questionnaire from baseline at 6 and 12 months. [ Time Frame: Baseline through 12 months ]
    Self report measures of cognition will be assessed through the Multiple Sclerosis Neuropsychological Questionnaire. Participants will complete this questionnaire at baseline, 6 month, and 12 months.

  5. Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline at 6 and 12 months. [ Time Frame: Baseline through 12 months ]
    Self report measures of fatigue will be assessed through the Fatigue Severity Scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  6. Change of self-report measures of Fatigue through the Modified Fatigue Impact Scale at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures of fatigue will be assessed through the Modified Fatigue Impact Scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  7. Change of self-report measures of Anxiety and Depression through the Hospital Anxiety and Depression Scale at 6 months and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures of Anxiety and Depression will be assessed through the Hospital Anxiety and Depression scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  8. Change of self-report measures of Pain through the Short-form of McGill Pain Questionnaire at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures of Pain will be assessed through the Short-form of McGill Pain Questionnaire. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  9. Changes of self-report measures of sleep through the Pittsburgh Sleep Quality Index at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures of sleep will be assessed through the Pittsburgh Sleep Quality Index. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  10. Changes of self-report measures of quality of life through the Medical Outcomes Study Short Form-36 at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures of quality of life will be assessed through the Medical Outcomes Study Short Form-36 . Participants will complete this questionnaire at baseline, 6 month, and 12 months

  11. Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures of quality of life will be assessed through the Multiple Sclerosis Impact Scale-29. Participants will complete this questionnaire at baseline, 6 month, and 12 months


Other Outcome Measures:
  1. 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. [ Time Frame: Baseline through 12 months ]
    Self report measures for self-efficacy will be assessed through the MS Self-Efficacy scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  2. 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. [ Time Frame: Baseline through 12 months ]
    Self report measures for self-efficacy will be assessed through the Exercise Self-Efficacy Scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  3. Changes of self-report measures based on goal setting through the Exercise Goal Setting and Planning Scale at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures for goal setting will be assessed through the Exercise Goal Setting and Planning Scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  4. Changes of self-report measures based on outcome expectations through the Multidimensional Outcome Expectancies for Exercise Scale at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures for outcome expectations will be assessed through the Multidimensional Outcome Expectancies for Exercise Scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  5. Changes of self-report measures based on quality of life through the Late-Life Function and Disability Inventory at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures for quality of life will be assessed through the Late-Life Function and Disability Inventory. Participants will complete this questionnaire at baseline, 6 month, and 12 months

  6. Changes of self-report measures based on quality of life through the Social Provisions Scale Inventory at 6 and 12 months from baseline. [ Time Frame: Baseline through 12 months ]
    Self report measures for quality of life will be assessed through the Social Provisions Scale. Participants will complete this questionnaire at baseline, 6 month, and 12 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MS
  • Relapse free in the past 30 days
  • Internet and email access
  • Willingness to complete the questionnaires, wear the accelerometer, and undergo randomization
  • 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 six months
  • Ability to ambulate with or without assistance (i.e. walking with or without a can or walker, but not a wheelchair)
  • Age between 18 and 64

Exclusion Criteria:

  • Moderate or high risk for undertaking strenuous or maximal exercise per participants response to the PAR-Q. Those who report no more than one YES or affirmative on the 7 item PAR-Q will be considered at low risk and included for participation. All others will be considered at moderate or high risk and excluded from participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490240


Contacts
Layout table for location contacts
Contact: Robert W Motl, PhD (205) 934-5905 robmotl@uab.edu

Locations
Layout table for location information
United States, Alabama
Exercise Neuroscience Research Lab Recruiting
Birmingham, Alabama, United States, 35233
Contact: Ariel Kidwell, MA    205-975-1490    enrl@uabmc.edu   
Principal Investigator: Robert W Motl, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
National Multiple Sclerosis Society
Investigators
Layout table for investigator information
Principal Investigator: Robert W Motl, PhD Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Robert W Motl, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03490240    
Other Study ID Numbers: 170609001
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases