Clinical trial NCT03468868: Comparative Effectiveness Study Telerehab Versus Conventional
Official title: Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Exercise
Physical activity
Telerehabilitation
Comparative effectiveness study
Social cognitive theory
Health behavior change
Lead sponsor: Shepherd Center, Atlanta GA
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: University of North Carolina, Chapel Hill
name: University of Georgia
name: The Cleveland Clinic
name: University of Colorado, Denver
name: Marquette University
name: Accelerated Cure Project for Multiple Sclerosis
name: Patient-Centered Outcomes Research Institute
name: Tanner Foundation for Multiple Sclerosis
name: Massachusetts General Hospital
First posted: 2018-03-19
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-stage randomized choice design aimed at noninferiority.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Timed 25 Foot Walk Test (T25FWT)
timeFrame: Change from baseline T25FWT at 16-weeks
Secondary outcomes:
measure: Six Minute Walk Test (6MWT)
timeFrame: Change from baseline at 16 weeks
measure: Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire
timeFrame: Change from baseline at 16 weeks
measure: Godin Leisure-Time Physical Activity (LTPA) Questionnaire
timeFrame: Change from baseline at 16 weeks
measure: Quality of Life in Neurological Disorders (Neuro-QOL) Survey
timeFrame: Change from baseline at 16 weeks.
measure: Multiple Sclerosis Impact Scale (MSIS)-29
timeFrame: Change from baseline at 16 weeks.
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from baseline at 16 weeks
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Change from baseline at 16 weeks
measure: Patient Determined Disease Steps (PDDS)
timeFrame: Change from baseline at 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Tanner Center for Multiple Sclerosis
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Athens
country: United States
facility: University of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Raleigh
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Shepherd Center, Atlanta GA
name: Deborah Backus, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22.
citation: Neal WN, Moldavskiy M, Truax B, Ithurburn A, Ware M, Hebert JR, Opielinski L, Penko AL, Kern K, Palmer L, Backus D, Motl RW. Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis. Contemp Clin Trials. 2023 Oct;133:107320. doi: 10.1016/j.cct.2023.107320. Epub 2023 Aug 24.
citation: Palmer LC, Neal WN, Motl RW, Backus D. The Impact of COVID-19 Lockdown Restrictions on Exercise Behavior Among People With Multiple Sclerosis Enrolled in an Exercise Trial: Qualitative Interview Study. JMIR Rehabil Assist Technol. 2022 Nov 22;9(4):e42157. doi: 10.2196/42157.
citation: Motl RW, Plummer P, Backus D, Hebert JR, Neal WN, Ng A, Lowman J, Bethoux F, Schmidt H, McBurney R, McCully KK, Cutter G. Validation of scores from a telephone administered multiple sclerosis walking scale-12 in persons with multiple sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105715. doi: 10.1016/j.msard.2024.105715. Epub 2024 Jun 9.