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Tele-Exercise and Multiple Sclerosis (TEAMS)

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ClinicalTrials.gov Identifier: NCT03117881
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Lakeshore Foundation
Alabama Neurology Associates, PC
Information provided by (Responsible Party):
James Rimmer, University of Alabama at Birmingham

Brief Summary:
The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM). Participants will be randomly assigned to one of these two groups.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: DirectCAM Behavioral: TeleCAM Not Applicable

Detailed Description:

There are few primary care and multiple sclerosis (MS) clinics that provide full exercise and rehabilitation services for patients with MS, especially in mostly rural, low‐income areas such as Alabama, Mississippi, and Tennessee. Telerehabilitation, or the delivery of rehabilitation services over the telephone and/or the Internet, can help fill service gaps for underserved MS patient populations in this region. The proposed study will determine if our evidence‐based rehabilitation and exercise program produces similar health outcomes when delivered in clinic or at home, using pre‐loaded tablets and Interactive Voice Response (IVR) system technology among 820 participants with MS from 38 clinics across Alabama, Mississippi, and Tennessee.

Outcomes we hope to achieve through the proposed rehabilitation and exercise program, referred to as complementary alternative medicine, are improved physical activity, decreased pain and fatigue, and quality of life. We also seek to improve attitudes and behaviors related to physical activity, such as outcome expectations for physical activity, social support from family and friends for physical activity, self‐efficacy (i.e., confidence in one's ability to be active), and self‐regulation (i.e., setting exercise goals). We will examine the variation in outcomes by patient characteristics such as age and severity of disability to determine for whom the intervention is effective.

This project is important to patients with MS because it seeks to reduce their barriers to receiving exercise treatment and increase the convenience and appeal of such programs through technology. Furthermore, findings and resources from this study will be quickly provided to MS patients and clinicians across the United States (e.g., via training webinars through our National Center on Health, Physical Activity, and Disability [NCHPAD]) and thereby improve the quality and reach of exercise treatment for patients with MS.

The patient and stakeholder partners include MS patients, caretakers, and clinicians, who have been actively guiding the development of this project. In stakeholder meetings, members have provided insight into exercise treatment needs and preferences (e.g., individually tailored approaches that account for varying levels of mobility); outcomes of interest to the patient population (e.g., pain, fatigue, quality of life); and strategies for engaging/motivating participants with MS who may be discouraged and experiencing fatigue and pain (e.g., IVR calls and feedback). Moreover, their ongoing program satisfaction feedback will be important to our recruitment and retention success. Finally, the stakeholders will help make this project successful by continuing to emphasize the importance of long‐term gains in health outcomes and promote (through NCHPAD) the sustainability of the program.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparative Effectiveness Trial Between a Clinic- and Home-Based Complementary and Alternative Medicine Telerehabilitation Intervention for Adults With Multiple Sclerosis (MS)
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DirectCAM
The DirectCAM arm will receive the intervention content in the rehabilitation clinic.
Behavioral: DirectCAM
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.

Experimental: TeleCAM
The TeleCAM arm will receive the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
Behavioral: TeleCAM
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.




Primary Outcome Measures :
  1. Pain [ Time Frame: 48 weeks ]
    Measured by 36-Item Short Form Survey (SF-36).

  2. Fatigue [ Time Frame: 48 weeks ]
    Measured by Modified Fatigue Impact Scale (MFIS).

  3. Quality of life [ Time Frame: 48 weeks ]
    Measured by 36-Item Short Form Survey (SF-36).

  4. Physical activity [ Time Frame: 48 weeks ]
    Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ).


Secondary Outcome Measures :
  1. Balance [ Time Frame: 48 weeks ]
    Measured using the Berg Balance Scale (BBS).

  2. Endurance [ Time Frame: 48 weeks ]
    Measured using the 6-minute Walk Test (6MWT).

  3. Gait [ Time Frame: 48 weeks ]
    Measured using the Timed 25-Foot Walk (T25-FW).

  4. Strength [ Time Frame: 48 weeks ]
    Measured using a hand-held dynamometer.


Other Outcome Measures:
  1. Outcome expectations for exercise [ Time Frame: 48 weeks ]
    Measured by the Multidimensional Outcome Expectations for Exercise Scale (MOEES).

  2. Exercise self-efficacy [ Time Frame: 48 weeks ]
    Measured by the Exercise Self-efficacy Scale.

  3. Social support for exercise [ Time Frame: 48 weeks ]
    Measured by the Social Provisions Scale.

  4. Exercise self-regulation [ Time Frame: 48 weeks ]
    Measured by the Exercise Goal-setting Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician permission to participate in the study
  • Mild to moderate disability (i.e., ambulate with/without assistive device, Patient-Determined Disease Steps [PDDS] 0 - 7
  • Able to use arms/legs for exercise

Exclusion Criteria:

  • Significant visual acuity that prevents seeing a tablet screen to follow home exercise program
  • Cardiovascular disease event within the last six months, several pulmonary disease, and/or renal failure
  • Active pressure ulcers
  • Currently pregnant
  • Within 30 days of receiving a rehabilitation program
  • Already meeting physical activity guidelines (GLTEQ > 24)

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): NCT03117881


Contacts
Contact: Whitney Neal, MA, CHES 205-403-5511 whitneyn@lakeshore.org
Contact: Tracy Tracy, OT, MSCS 205-803-2210 ext 2 ttracy@alaneuro.com

Locations
United States, Alabama
Drayer Physical Therapy Institute Not yet recruiting
Athens, Alabama, United States, 35613
Contact: Katie Shipman, PT    256-233-2313      
Contact: Ethan Hoback, PTA    256-233-2313      
Drayer Physical Therapy Institute Not yet recruiting
Bessemer, Alabama, United States, 35022
Contact: Jennifer Glascock, PT    205-230-0400      
Contact: Richard Riley, PTA    205-230-0400      
Tanner Foundation Recruiting
Birmingham, Alabama, United States, 35209
Contact: Bess Martin, PT    205-803-2210      
Contact: Virginia Weinacker, PT    205-803-2210      
Drayer Physical Therapy Institute Not yet recruiting
Calera, Alabama, United States, 35040
Contact: Lauren James, PT    205-668-6900      
Contact: Krystale Barksdale, PT    205-668-6900      
Drayer Physical Therapy Institute Recruiting
Cullman, Alabama, United States, 35058
Contact: Scott Cooley, PTA    256-739-1370      
Southeast Alabama Medical Center Rehabilitation Services Not yet recruiting
Dothan, Alabama, United States, 36301
Contact: Lindsay Hollman, PT    334-712-3726      
Contact: Elizabeth Reinelt, PTA    334-712-3726      
Gulf Coast Therapy Not yet recruiting
Fairhope, Alabama, United States, 36532
Contact: Cindy Powell, CHT    251-928-7312      
Gulf Coast Therapy Not yet recruiting
Foley, Alabama, United States, 36536
Contact: Cindy Powell, CHT    251-823-0888      
Encore Rehabilitation Not yet recruiting
Fort Payne, Alabama, United States, 35967
Contact: Kimberly Bryan, PT         
Contact: Lisa Goldman, PT         
Drayer Physical Therapy Institute Not yet recruiting
Gadsden, Alabama, United States, 35906
Contact: Cory Fuller, PT    256-549-6387      
Contact: Sam Norton, PTA    256-549-6387      
Therapy Achievements Not yet recruiting
Huntsville, Alabama, United States, 35801
Contact: Karen Hislop, OT    256-509-4398      
Contact: Kristen McCombs, OTA    256-509-4398      
Drayer Physical Therapy Institute Not yet recruiting
Jacksonville, Alabama, United States, 36265
Contact: Andrew Gulbert    256-365-2792      
Contact: James Warren    256-365-2792      
Drayer Physical Therapy Institute Not yet recruiting
Jasper, Alabama, United States, 35501
Contact: Judy Gazdag, PT    205-385-7919      
Contact: Alayna Jordan, PTA    205-385-7919      
Gulf Coast Therapy Not yet recruiting
Mobile, Alabama, United States, 36607
Contact: Cindy Powell, CHT    251-476-0525      
Montgomery East Physical Therapy Recruiting
Montgomery, Alabama, United States, 36117
Contact: Linda Perez, PT    334-244-5892      
Contact: Sandra Whaley, PT    334-244-5892      
Drayer Physical Therapy Institute Not yet recruiting
Muscle Shoals, Alabama, United States, 35674
Contact: Erin Pounders, PT    256-978-4001      
Contact: Julie Glasgow, PT    256-978-4001      
Drayer Physical Therapy Institute Not yet recruiting
Prattville, Alabama, United States, 36066
Contact: Pengfei Hao, PT    334-380-4930      
Contact: Casey Henley, PT    334-380-4930      
Drayer Physical Therapy Institute Not yet recruiting
Tuscaloosa, Alabama, United States, 35046
Contact: Tracy Leavelle, PT    205-752-0845      
Contact: Zachary Cox, PT    205-752-0845      
United States, Mississippi
Drayer Physical Therapy Institute Not yet recruiting
Amory, Mississippi, United States, 38821
Contact: Alyson Key, PT    662-257-4048      
Contact: Kelcie Sawyerpage, PT    662-257-4048      
Cornerstone Rehabilitation Not yet recruiting
Batesville, Mississippi, United States, 38668
Contact: Andrew Jerries, PT    662-578-7799      
Contact: Will Gusmus, PTA    662-578-7799      
Drayer Physical Therapy Institute Not yet recruiting
Byram, Mississippi, United States, 39272
Contact: Jason Downard, PT    601-346-9191      
Contact: Reid Harrison, PT    601-346-9191      
Drayer Physical Therapy Institute Not yet recruiting
Canton, Mississippi, United States, 39046
Contact: Rachel Smith, PT    601-859-3776      
Drayer Physical Therapy Institute Recruiting
Columbus, Mississippi, United States, 39702
Contact: Kayla Hatcher, PT    662-241-4545      
Contact: Emily Myers, PT    662-241-4545      
Drayer Physical Therapy Institute Not yet recruiting
Fulton, Mississippi, United States, 38843
Contact: Jackie Smith, PT    662-862-4104      
Contact: Amy Brown, PTA    662-862-4104      
Drayer Physical Therapy Institute Recruiting
Hattiesburg, Mississippi, United States, 39402
Contact: Doug Peterman, PT    601-336-7155      
Contact: Catherine Crutcher, PT    601-336-7155      
Methodist Rehabilitation Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Susan Geiger, PT    601-981-2611      
Contact: Lisa Indset, PT    601-981-2611      
Encore Rehabilitation Recruiting
Ocean Springs, Mississippi, United States, 39564
Contact: Ashley Campbell, PT         
Contact: Amy Farrar, PT         
Drayer Physical Therapy Institute Not yet recruiting
Saltillo, Mississippi, United States, 38866
Contact: Van Johnson, PT    662-869-9980      
Contact: Jennifer Lollar, PTA    662-869-9980      
Cornerstone Rehabilitation Not yet recruiting
Southaven, Mississippi, United States, 38671
Contact: Jason Brady, PT    662-349-2489      
Contact: Katie Pounds    662-349-2489      
Drayer Physical Therapy Institute Not yet recruiting
Tupelo, Mississippi, United States, 38801
Contact: Joe Elmer, PT    662-680-5216      
Contact: Jermenta Gardner, PTA    662-680-5216      
Cornerstone Rehabilitation Not yet recruiting
Water Valley, Mississippi, United States, 38965
Contact: Jennifer McGavock, PT    662-473-4777      
Contact: Chad Montgomery, PTA    662-473-4777      
Drayer Physical Therapy Institute Not yet recruiting
Wiggins, Mississippi, United States, 39577
Contact: Whitney Robinson, PT    601-928-5511      
Contact: Ryan Harrell, PT    601-928-5511      
United States, Tennessee
Drayer Physical Therapy Institute Not yet recruiting
Cool Springs, Tennessee, United States, 37067
Contact: Laura Spraetz, PT         
Drayer Physical Therapy Institute Not yet recruiting
Gordonsville, Tennessee, United States, 38563
Contact: Julian McGee, PT         
Drayer Physical Therapy Institute Recruiting
Knoxville, Tennessee, United States, 37931
Contact: Danielle Hmielewski, PT         
Drayer Physical Therapy Institute Not yet recruiting
Newport, Tennessee, United States, 37821
Contact: Tracy Tracy, OT, MSCS         
Drayer Physical Therapy Institute Not yet recruiting
Smyrna, Tennessee, United States, 37167
Contact: Tracy Tracy, OT, MSCS         
Drayer Physical Therapy Institute Not yet recruiting
Winchester, Tennessee, United States, 37398
Contact: Leslie Sharpe, PT         
Sponsors and Collaborators
University of Alabama at Birmingham
Patient-Centered Outcomes Research Institute
Lakeshore Foundation
Alabama Neurology Associates, PC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Rimmer, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03117881     History of Changes
Other Study ID Numbers: F161017003
MS-1511-33653 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Rimmer, University of Alabama at Birmingham:
Multiple Sclerosis
Yoga
Pilates
Telerehabilitation
Physical activity

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases