NCT03256851

Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

Completed NA Results posted Last updated 30 October 2019

What this trial tests

NA trial testing Telephone-Delivered Exercise Therapy in Multiple Sclerosis in 20 participants. Completed in 31 July 2018.

Timeline

1 June 2017

Primary endpoint
31 May 2018

31 July 2018

Quick facts

Lead sponsor	Wayne State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 June 2017
Primary completion	31 May 2018
Estimated completion	31 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Telephone-Delivered Exercise Therapy
• In-Person Delivered Exercise Therapy

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Fatigue — all drugs for Fatigue →
• Physical Activity — all drugs for Physical Activity →

Sponsor

Wayne State University

Who can join

18 and older, any sex, with Multiple Sclerosis or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Daily Average Fatigue Intensity Score Primary · Baseline (pre) and 8 weeks (post)

Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures. A score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue.

Pre

Group	Value	95% CI
In-Person Delivered Exercise	3.9	± 1.9
Telephone-Delivered Exercise	4.4	± 1.1

Post

Group	Value	95% CI
In-Person Delivered Exercise	3.2	± 1.9
Telephone-Delivered Exercise	2.3	± 1.5

Daily Average Fatigue Interference Score Primary · Baseline (pre) and 8 weeks (post)

Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse).

Pre

Group	Value	95% CI
In-Person Delivered Exercise	3.1	± 1.9
Telephone-Delivered Exercise	3.0	± 1.3

Post

Group	Value	95% CI
In-Person Delivered Exercise	2.7	± 1.8
Telephone-Delivered Exercise	1.5	± 1.7

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Synaptic Plasticity in Neurodegenerative Diseases: Impact of Exercise as Promising Therapeutic Tool.
   Farina G, Fenili G, Paronetto MP, Crescioli C. · · 2026 · PMID 41597271 · DOI 10.3390/cells15020197