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Completed

NCT Number: NCT03256851

Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone-Delivered Exercise Therapy

Behavioral

A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.

Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.

Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.

This home exercise program will be paired with a 1x/week telephone call with an investigator.

In-Person Delivered Exercise Therapy

Behavioral

A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.

Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.

Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.

This home exercise program will be paired with a 1x/week visit to the laboratory to work with a physical therapist or trained team member.

Primary outcomes

  1. Daily Average Fatigue Intensity Score

    Time frame: 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.

  2. Daily Average Fatigue Interference Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • National Multiple Sclerosis Society
  • University of Michigan

Registry information

Official study title

Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2017
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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