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Tele-Exercise and Multiple Sclerosis (TEAMS)

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: NCT03117881
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Lakeshore Foundation
Tanner Center for Multiple Sclerosis
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.

**On March 16th, 2020, the University of Alabama at Birmingham halted all onsite non-essential research in response to the Covid-19 pandemic. Since then, the study has begun to conduct all testing remotely through videoconferencing technology. In addition, another study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue the 12-week program delivery for newly recruited participants via videoconferencing technology.**


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: DirectCAM Behavioral: TeleCAM Behavioral: rDirectCAM 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 759 participants with MS from 40 clinics across Alabama, Mississippi, and Tennessee.

**In response to the Covid-19 pandemic, the study aims to recruit 74 participants with MS into the rDirectCAM, where the 12-week program is delivered in real-time via videoconferencing technology. The rDirectCAM will determine if a telehealth rehabilitation program can have a similar effect as when the program is offered in person.**

The outcomes that 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 833 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 : October 30, 2021
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DirectCAM
The DirectCAM arm receives the intervention content via therapists at participating clinics.
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 receives 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.

Experimental: rDirectCAM
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
Behavioral: rDirectCAM
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 by a therapist via videoconferencing technology. 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.




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

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 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
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Contact: Emily Goodner, MS 205-403-5512 emilysg@uab.edu
Contact: Hui-Ju Young, PhD 205-403-5521 hjyoung@uab.edu

Locations
Show Show 40 study locations
Sponsors and Collaborators
University of Alabama at Birmingham
Patient-Centered Outcomes Research Institute
Lakeshore Foundation
Tanner Center for Multiple Sclerosis
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Rimmer, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03117881    
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: October 19, 2020
Last Verified: October 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 James Rimmer, University of Alabama at Birmingham:
Multiple Sclerosis
Yoga
Pilates
Telerehabilitation
Physical activity
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