Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

NCT ID: NCT03256851

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-07-31

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.

Conditions

Multiple Sclerosis; Fatigue; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

In-Person Delivered Exercise

Participants in the in-person training group will:

1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.

2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.

Group Type: ACTIVE_COMPARATOR

In-Person Delivered Exercise Therapy

Intervention Type: 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.

Telephone-Delivered Exercise

Participants in the telephone-delivered training group will:

1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.

2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report their progress from the prior week, discuss/troubleshoot any issues or problems, and receive progressions of both aerobic and strength training exercises for the upcoming week.

Group Type: EXPERIMENTAL

Telephone-Delivered Exercise Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Nora Fritz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wayne State University

Detroit, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31738192 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1612000180

Identifier Type: -

Identifier Source: org_study_id