Clinical trial NCT03256851: Telephone-Delivered Exercise for Multiple Sclerosis Fatigue
Official title: Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Physical Activity
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: University of Michigan
First posted: 2017-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Daily Average Fatigue Intensity Score
timeFrame: Baseline (pre) and 8 weeks (post)
measure: Daily Average Fatigue Interference Score
timeFrame: Baseline (pre) and 8 weeks (post)
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References:
citation: Kratz AL, Atalla M, Whibley D, Myles A, Thurston T, Fritz NE. Calling Out MS Fatigue: Feasibility and Preliminary Effects of a Pilot Randomized Telephone-Delivered Exercise Intervention for Multiple Sclerosis Fatigue. J Neurol Phys Ther. 2020 Jan;44(1):23-31. doi: 10.1097/NPT.0000000000000296.