Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue

CompletedNot a drug-phase studyRelapsing and progressiveNCT03256851

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Telephone-Delivered Exercise Therapy

Compared with

  • In-Person Delivered Exercise Therapy

Results by group

Daily Average Fatigue Intensity Score

Baseline (pre) and 8 weeks (post)

GroupValueIntervalNumber analysed
In-Person Delivered Exercise3.9 units on a scale1.9 (Standard Deviation)9
Telephone-Delivered Exercise4.4 units on a scale1.1 (Standard Deviation)10
In-Person Delivered Exercise3.2 units on a scale1.9 (Standard Deviation)9
Telephone-Delivered Exercise2.3 units on a scale1.5 (Standard Deviation)10

In-Person Delivered Exercise

3.9

Telephone-Delivered Exercise

4.4

In-Person Delivered Exercise

3.2

Telephone-Delivered Exercise

2.3

Daily Average Fatigue Interference Score

Baseline (pre) and 8 weeks (post)

GroupValueIntervalNumber analysed
In-Person Delivered Exercise3.1 units on a scale1.9 (Standard Deviation)9
Telephone-Delivered Exercise3.0 units on a scale1.3 (Standard Deviation)10
In-Person Delivered Exercise2.7 units on a scale1.8 (Standard Deviation)9
Telephone-Delivered Exercise1.5 units on a scale1.7 (Standard Deviation)10

In-Person Delivered Exercise

3.1

Telephone-Delivered Exercise

3

In-Person Delivered Exercise

2.7

Telephone-Delivered Exercise

1.5

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
In-Person Delivered Exercise100 (0.0%)0
Telephone-Delivered Exercise100 (0.0%)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

  • Daily Average Fatigue Intensity Score

    Baseline (pre) and 8 weeks (post)

    Fatigue
  • Daily Average Fatigue Interference Score

    Baseline (pre) and 8 weeks (post)

    Fatigue

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

* Diagnosis of RRMS, SPMS, or PPMS * Ambulatory for at least 5 minutes at a time * Self-reported fatigue on Fatigue Severity Scale * Able to follow study-related commands * Able to attend study appointments

Exclusion criteria

* MS exacerbation within the past 30 days * Evidence of another neurological disorder or orthopedic disorder that would interfere with exercise participation * Acute illness or injury that prevents participation in the intervention * Pregnancy

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

About this trial

In the sponsor's words

Multiple sclerosis (MS) is a progressive demyelinating disorder that damages white matter in the central nervous system. Although individuals experience mobility (e.g., walking, balance) impairments that lower quality of life and limit participation in daily activities, one of the most prominent symptoms is fatigue. Up to 92% of individuals report fatigue that manifests as lack of energy, exhaustion or worsening of MS symptoms and ultimately contributes to increasing disability. The currently available pharmaceutical treatments fail to fully control fatigue in the majority of individuals with MS; non-pharmacologic therapies such as exercise and behavioral therapies offer the best hope for combating MS fatigue in the majority of individuals. Exercise therapy is effective in reducing MS fatigue. However, access to exercise therapy is seriously limited for many individuals with MS due to geographical location, limited resources (e.g., financial, transportation), and/or disability. Thus, the development and evaluation of an alternative delivery method for exercise therapy to target MS-related fatigue that increases participation and reduces barriers is critical. In this study, the investigators will compare traditional in-person delivered exercise therapy to telephone-delivered exercise therapy to target fatigue in persons with MS.

Papers

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History

    1. Started

      Jun 2017

    2. Main results due

      May 2018

    3. Finished

      Jul 2018

    4. Results posted

      Oct 2019

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