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Comparative Effectiveness Study Telerehab Versus Conventional

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ClinicalTrials.gov Identifier: NCT03468868
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : April 6, 2020
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of North Carolina, Chapel Hill
University of Georgia
The Cleveland Clinic
University of Colorado, Denver
Marquette University
Accelerated Cure Project for Multiple Sclerosis
Patient-Centered Outcomes Research Institute
Tanner Foundation for Multiple Sclerosis
Massachusetts General Hospital
Information provided by (Responsible Party):
Deborah Backus, Shepherd Center, Atlanta GA

Brief Summary:
This study aims to compare the effectiveness of an exercise program delivered in a conventional facility-based format versus a telerehabilitation format, which takes place in the home. Exercise can improve mobility and perhaps decrease the rate and extent of disability in people with MS. Evidence shows that traditional, facility-based exercise training may help people with MS consistently participate in exercise or to exercise at a higher, more intense level. Despite this evidence, lack of access to facility-based exercise programs may make it difficult for people with MS to engage in exercise.Telerehabilitation (telerehab) has great potential to overcome challenges associated with facility-based programs. Telerehab can include videoconferencing, remote monitoring of signs and activity, and dissemination of specialized and individualized information via electronic mechanisms, such as smartphones and computers. Both facility-based and telerehab exercise training have yielded positive results in people with MS, but have not been compared head-to-head. The current study will fill this gap in the evidence base and compare the outcomes of delivering the same exercise interventions in a facility or in the home/community using a telerehab approach. The interventions are designed to be identical in content, with the only difference being the mode of training delivery.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Exercise program for people with MS Not Applicable

Detailed Description:

Funded by Patient-Centered Outcomes Research Institute (PCORI), this four-year, multi-site study aims to compare the effectiveness of a 16-week telerehabilitation (telerehab) exercise program and a facility-based exercise program on Multiple Sclerosis (MS) outcomes. The research study design is a two-stage randomized choice design aimed at non-inferiority.

Four hundred participants with MS who have ambulatory difficulties will be recruited from nine sites. First level randomization will assign participants to one of two groups - Choice or Random. The participants in Choice will be able to choose in which program they wish to participate (telerehab or facility-based). Individuals in the Random group, will be further randomized to either the telerehab or facility-based program. The research protocol and associated tools will be reviewed and approved by all relevant Research Review Committees before any research takes place. The study will comply with best practices in human subjects' research including following HIPAA guidelines and using strict informed consent procedures. Clinical reported outcome measures and patient reported outcome measures will be administered at baseline, immediately post-intervention (at 16 weeks), and at 12 months post-intervention. Patient reported outcomes will also be administered at 2 months and 6 months after the start of the intervention.

Dr. Deborah Backus is the principal investigator (PI) and Prof. Robert Motl is the co-Principal Investigator supported by collaborating co-Investigators at the Cleveland Clinic Mellen Center, Ohio; Marquette University, Wisconsin; University of Colorado, Denver; University of North Carolina, Chapel Hill; the University of Georgia; the Tanner Center for Multiple Sclerosis, Birmingham Alabama; Massachusetts General Hospital, Boston, Massachusetts; and the iConquerMS outcomes data collaborative (Accelerated Cure Project for MS). Shepherd Center is the primary and coordinating site for all study activities under Dr. Backus. University of Alabama at Birmingham (UAB) under the leadership of Prof. Motl will oversee delivery of the training programs, and statistical analysis under the direction of Dr. Gary Cutter.

This study will yield important data regarding the comparative impact of exercise programs on MS outcomes and provide information to people with MS, health providers, payers, exercise partners, and policy makers about how people with MS who have ambulatory difficulties can safely and effectively exercise.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-stage randomized choice design aimed at noninferiority.
Masking: Single (Outcomes Assessor)
Masking Description: Evaluators who assess clinical reported outcomes will be blinded to arm assignment.
Primary Purpose: Supportive Care
Official Title: Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Facility-based rehabilitation
Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.
Behavioral: Exercise program for people with MS
The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.

Active Comparator: Telerehabilitation
Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.
Behavioral: Exercise program for people with MS
The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.




Primary Outcome Measures :
  1. Timed 25 Foot Walk Test (T25FWT) [ Time Frame: Change from baseline T25FWT at 16-weeks and at 12 months post intervention ]
    Measure of walking speed


Secondary Outcome Measures :
  1. Six Minute Walk Test [ Time Frame: Change from baseline at 16 weeks and 12 months post intervention ]
    Measures walking endurance

  2. Multiple Sclerosis Walking Scale-12 questionnaire [ Time Frame: Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention ]
    Measures the impact of MS on walking ability and daily activities over the past two weeks

  3. Godin Leisure-Time questionnaire [ Time Frame: Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention ]
    7-day recall of leisure-time physical activity to determine individual's activity level

  4. Quality of Life in Neurological Disorders (Neuro-QOL) survey [ Time Frame: Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention ]
    A validated outcome measure of quality of life

  5. Unidimensional Fatigue Impact Score [ Time Frame: Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention ]
    A self-report measure of fatigue in people with MS. The total score for the MFIS is the sum of the scores for the 22 items and can range from 0 to 88. Higher scores indicate a greater impact of fatigue on a person's activities.

  6. Multiple Sclerosis Impact Scale-29 [ Time Frame: Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention ]
    Measures individual's views on the impact of MS on day-to-day life during the past two weeks. It has two subscales: a 20-item physical impact scale and a 9-item psychological impact scale (and no total score). Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36, with lower scores indicating little impact of MS and higher scores indicating greater impact.

  7. Modified Fatigue Impact Scale [ Time Frame: Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention ]
    Measures impact of fatigue on the participant's activities and lifestyle over the past four weeks. The total score for the MFIS is the sum of the scores for the 21 items and can range from 0 to 84. Higher scores indicate a greater impact of fatigue on a person's activities.

  8. Social Cognitive Theory (SCT) [ Time Frame: Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention ]
    A battery of measures to measure the core SCT constructs of self-efficacy, outcome expectations, goal setting, self-monitoring, overcoming barriers, perceived social support.

  9. Expanded Disability Status Scale [ Time Frame: Change from baseline at 16 weeks and 12 months post intervention ]
    Characterizes disability level and determines disability progression in people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability (0 equals low).

  10. Patient Determined Disease Steps [ Time Frame: Change from baseline at 16 weeks and 12 months post intervention ]
    Patient reported measure of disability in MS. The scale ranges from 0 to 8.



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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate MS
  • Has limitations in walking but can walk 25 feet
  • Does not participate in a rigorous exercise program
  • Can travel to trial site for assessments and training

Exclusion Criteria:

  • Relapse in the past 30 days
  • Other neurological or musculoskeletal disorders

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): NCT03468868


Contacts
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Contact: Louise Palmer, MA 404-350-7513 louise.palmer@shepherd.org

Locations
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United States, Alabama
The Tanner Center for Multiple Sclerosis Recruiting
Birmingham, Alabama, United States, 35209
Contact: Gigi Weinacker    205-803-2210 ext 2    gweinacker@alaneuro.com   
Principal Investigator: Emily Riser, MD         
University of Alabama Recruiting
Birmingham, Alabama, United States, 35209
Contact: Petra Silic    205-975-1306    petra09@uab.edu   
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Alexa Vareldzis       alexa.vareldzis@cuanschutz.edu   
Contact: Holly Borland    303-724-4644    holly.borland@cuanschutz.edu   
United States, Georgia
University of Georgia Recruiting
Athens, Georgia, United States, 30602
Contact: Megan Ware    423-260-5045    megan.ware20@uga.edu   
Shepherd Center Recruiting
Atlanta, Georgia, United States, 30309
Contact: Erica Sutton    404-367-1305    Erica.sutton@shepherd.org   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Prudence Plummer, PT, PhD    919-843-8658    pplummer@mghihp.edu   
Principal Investigator: Prudence Plummer, PT, PhD         
United States, North Carolina
University of North Carolina Recruiting
Raleigh, North Carolina, United States, 27599
Contact: Rachel Keen    704-877-5636    rayray@live.unc.edu   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Darlene Stough, MD    216-445-5877    stoughd@ccf.org   
Contact: Dee Ivancic    216-444-5441    ivancid@ccf.org   
United States, Wisconsin
Marquette University Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Heidi Feuling    414-288-6209    heidi.feuling@marquette.edu   
Sponsors and Collaborators
Shepherd Center, Atlanta GA
University of Alabama at Birmingham
University of North Carolina, Chapel Hill
University of Georgia
The Cleveland Clinic
University of Colorado, Denver
Marquette University
Accelerated Cure Project for Multiple Sclerosis
Patient-Centered Outcomes Research Institute
Tanner Foundation for Multiple Sclerosis
Massachusetts General Hospital
Investigators
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Principal Investigator: Deborah Backus, PhD Shepherd Center, Atlanta GA
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Responsible Party: Deborah Backus, Director of Multiple Sclerosis Research, Shepherd Center, Atlanta GA
ClinicalTrials.gov Identifier: NCT03468868    
Other Study ID Numbers: MS-1610-36999
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deborah Backus, Shepherd Center, Atlanta GA:
Multiple sclerosis
Exercise
Physical activity
Telerehabilitation
Comparative effectiveness study
Social cognitive theory
Health behavior change
Additional relevant MeSH terms:
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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