Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

NCT03256851 | Completed Results

• 1 other identifier: 1612000180
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

In-Person Delivered Exercise

ACTIVE COMPARATOR

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.

Behavioral: In-Person Delivered Exercise Therapy

Telephone-Delivered Exercise

EXPERIMENTAL

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.

Behavioral: Telephone-Delivered Exercise Therapy

Interventions

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.

Telephone-Delivered Exercise

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.

In-Person Delivered Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• National Multiple Sclerosis Society: collaborator
• University of Michigan: collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• 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.

  PMID: 31738192 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Nora Fritz
• Organization: Wayne State University

nora.fritz@wayne.edu

(313) 577-1096

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: June 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 30, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)