Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

Multiple Sclerosis Clinical Trial

Official title:

Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256851
• Other study ID #: 1612000180
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2019
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Physical Activity
• Sclerosis

Intervention

Behavioral:
• Telephone-Delivered Exercise Therapy
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
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.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Wayne State University	National Multiple Sclerosis Society, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Average Fatigue Intensity Score	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.	Baseline (pre) and 8 weeks (post)
Primary	Daily Average Fatigue Interference Score	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).	Baseline (pre) and 8 weeks (post)