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Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

Primary Purpose

Multiple Sclerosis, Fatigue, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-Delivered Exercise Therapy
In-Person Delivered Exercise Therapy
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-Person Delivered Exercise

Telephone-Delivered Exercise

Arm Description

Participants in the in-person training group will: participate in a home exercise program including aerobic training 2x/week and strength training 3x/week. 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.

Participants in the telephone-delivered training group will: participate in a home exercise program including aerobic training 2x/week and strength training 3x/week. 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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
August 16, 2017
Last Updated
October 7, 2019
Sponsor
Wayne State University
Collaborators
National Multiple Sclerosis Society, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03256851
Brief Title
Telephone-Delivered Exercise for Multiple Sclerosis Fatigue
Official Title
Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Multiple Sclerosis Society, University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Fatigue, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-Person Delivered Exercise
Arm Type
Active Comparator
Arm Description
Participants in the in-person training group will: participate in a home exercise program including aerobic training 2x/week and strength training 3x/week. 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.
Arm Title
Telephone-Delivered Exercise
Arm Type
Experimental
Arm Description
Participants in the telephone-delivered training group will: participate in a home exercise program including aerobic training 2x/week and strength training 3x/week. 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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Delivered Exercise Therapy
Intervention Description
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
Intervention Name(s)
In-Person Delivered Exercise Therapy
Intervention Description
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 Outcome Measure Information:
Title
Daily Average Fatigue Intensity Score
Description
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.
Time Frame
Baseline (pre) and 8 weeks (post)
Title
Daily Average Fatigue Interference Score
Description
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).
Time Frame
Baseline (pre) and 8 weeks (post)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31738192
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.
Results Reference
derived

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Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

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