Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery

CompletedNot a drug-phase studyMS (type not specified)NCT03468868

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Exercise program for people with MS

Results by group

Timed 25 Foot Walk Test (T25FWT)

Change from baseline T25FWT at 16-weeks

GroupValueIntervalNumber analysed
Facility-based Rehabilitation2.88 feet per second0.85 (Standard Deviation)198
Telerehabilitation2.62 feet per second0.94 (Standard Deviation)181
Facility-based Rehabilitation3.41 feet per second1.12 (Standard Deviation)198
Telerehabilitation3.26 feet per second1.08 (Standard Deviation)181

Facility-based Rehabilitation

2.88

Telerehabilitation

2.62

Facility-based Rehabilitation

3.41

Telerehabilitation

3.26

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Facility-based Rehabilitation1988 (4.0%)0
Telerehabilitation1812 (1.1%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Timed 25 Foot Walk Test (T25FWT)

    Change from baseline T25FWT at 16-weeks

    Disability progressionWalking and mobility

Other measures (8)

  • Six Minute Walk Test (6MWT)

    Change from baseline at 16 weeks

    Walking and mobilityPhysical function
  • Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire

    Change from baseline at 16 weeks

    Walking and mobility
  • Godin Leisure-Time Physical Activity (LTPA) Questionnaire

    Change from baseline at 16 weeks

    Walking and mobilityPhysical function
  • Quality of Life in Neurological Disorders (Neuro-QOL) Survey

    Change from baseline at 16 weeks.

    Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)
  • Multiple Sclerosis Impact Scale (MSIS)-29

    Change from baseline at 16 weeks.

    Quality of life (reported by participants)
  • Modified Fatigue Impact Scale (MFIS)

    Change from baseline at 16 weeks

    Thinking and memoryFatigue
  • Expanded Disability Status Scale (EDSS)

    Change from baseline at 16 weeks

    Disability progression
  • Patient Determined Disease Steps (PDDS)

    Change from baseline at 16 weeks

    Walking and mobilityQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jul 2018

    2. Main results due

      Sept 2023

    3. Finished

      Sept 2023

    4. Results posted

      Dec 2024

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