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Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory Muscle Trainer (IMT)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Inspiratory Muscle Training

Eligibility Criteria

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

Inclusion Criteria:

  • Residents of The Boston Home
  • Diagnosis of multiple sclerosis by a physician
  • Expanded Disability Status Scale >6.5
  • Able to follow instructions in English

Exclusion Criteria:

  • Hospitalization for exacerbation of MS within the previous 2 months
  • Unstable heart, lung, or other physical conditions
  • Current smoker
  • Oral temperature greater than 100 degrees Fahrenheit
  • Acute illness, such as infection, inflammation, ongoing chest pain, or short of breath with light activities
  • Current neurological diseases other than MS

Sites / Locations

  • The Boston Home
  • University of Michigan-Flint

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inspiratory Muscle Trainer (IMT)

Arm Description

Inspiratory Muscle Trainer (IMT) provides resistance as a person inhales, thereby strengthening respiratory muscles.

Outcomes

Primary Outcome Measures

Change in Maximal inspiratory Pressure (MIP)
MIP will be obtained using Micro Respiratory Pressure Meter (MicroRPM). Participants will perform three trials and the best value of the three attempts will be used.
Change in Maximal Expiratory Pressure (MEP)
MEP will be obtained using Micro Respiratory Pressure Meter (MicroRPM). Participants will perform three trials and the best value of the three attempts will be used.

Secondary Outcome Measures

Change in Fatigue
Fatigue will be measured by Modified Fatigue Impact Scale, where 0 is no impact and 20 is most severe impact on daily life
Change in Activity Participation
The average number of recreational programs attended by each participant per day.
Change in Respiratory Infection Incidents
The total number of incidence of respiratory infection of each participant. All incidence of respiratory infection will be documented by nursing staff.

Full Information

First Posted
November 13, 2017
Last Updated
April 29, 2019
Sponsor
University of Michigan
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT03345199
Brief Title
Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis
Official Title
Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 28, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

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

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
This study evaluates the effects of a 10-week inspiratory muscle training on the outcomes of respiratory muscle strength, fatigue, activity participation, and respiratory infection rates in persons with advanced Multiple Sclerosis (MS). Participants will perform daily exercise using the Threshold Inspiratory Muscle Trainer (IMT) device during the training period. The study will assess whether the participants improve after the training, and whether the effects can be maintained after the training ends.
Detailed Description
People with advanced multiple sclerosis (MS) often experience impairments in strength and endurance in the muscles of respiration. This can cause increased difficulty with breathing which may lead to increased respiratory infection. People with weak respiratory muscles may need to use more effort for breathing and this can be tiring and limiting a person's ability to participate in activities. Complications from breathing problems, such as pneumonia, are the most frequent reason for critical illness and intensive care in people with MS, particularly as the disease progresses. Exercises of the respiratory muscles have the potential to improve breathing in people with MS. The goal of this study is to examine the effects of a 10-week respiratory muscle exercise program on respiratory muscle strength, fatigue, activity level, and respiratory infection rates in people with advanced MS. The study will assess whether the participants improve after the training, and whether the effects can be maintained after the training ends. The study will invite 40 people with advanced MS to participate in a 10-week exercise program to strengthen respiratory muscles. Participants will use a device that is easy to use and provides a resistance while inhaling. Participants will perform the exercises after they receive the instruction from researchers. The progression of exercises will be tailored to each individual's tolerance to the exercise. The study will measure participants' respiratory muscle strength, perceived fatigue, participation in daily recreational activities such as coffee time, and respiratory infection rates to evaluate the effects of the program. The measurements will be done upon enrollment into the study at the baseline, after 10-week no training baseline period before the intervention, mid-point during the 10-week training, at the completion of the 10-week training, at 4 weeks and at 8 weeks after the training ends. The study will evaluate if participants improve after the training, and if the improvements can be maintained for up to 8 weeks after the training. Outcomes from this research will help to better understand effective treatments for breathing problems in people with advanced MS. The study will be able to inform clinicians and researchers about effective protocols for respiratory muscle training in advanced MS. These results will contribute to long-term research goals, including reducing complications from respiratory problems, delaying disability associated with MS, and improving function and quality of life in people with advanced MS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Inspiratory Muscle Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Trainer (IMT)
Arm Type
Experimental
Arm Description
Inspiratory Muscle Trainer (IMT) provides resistance as a person inhales, thereby strengthening respiratory muscles.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Trainer (IMT)
Intervention Description
During the 10-week training period, participants will perform exercises using a Threshold Inspiratory Muscle Trainer (IMT) at 3 sets of 15 repetitions per day. The initial resistance of the IMT unit will be at 30% of participants' maximum inspiratory pressure (MIP). Resistance for the IMT unit will be increased progressively and adjusted weekly by a licensed physical therapist based on participant's MIP at baseline, Borg perceived rate of exertion, and symptoms.
Primary Outcome Measure Information:
Title
Change in Maximal inspiratory Pressure (MIP)
Description
MIP will be obtained using Micro Respiratory Pressure Meter (MicroRPM). Participants will perform three trials and the best value of the three attempts will be used.
Time Frame
Baseline to 28 weeks
Title
Change in Maximal Expiratory Pressure (MEP)
Description
MEP will be obtained using Micro Respiratory Pressure Meter (MicroRPM). Participants will perform three trials and the best value of the three attempts will be used.
Time Frame
Baseline to 28 weeks
Secondary Outcome Measure Information:
Title
Change in Fatigue
Description
Fatigue will be measured by Modified Fatigue Impact Scale, where 0 is no impact and 20 is most severe impact on daily life
Time Frame
Baseline to 28 weeks
Title
Change in Activity Participation
Description
The average number of recreational programs attended by each participant per day.
Time Frame
Baseline to 28 weeks
Title
Change in Respiratory Infection Incidents
Description
The total number of incidence of respiratory infection of each participant. All incidence of respiratory infection will be documented by nursing staff.
Time Frame
Baseline to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Residents of The Boston Home Diagnosis of multiple sclerosis by a physician Expanded Disability Status Scale >6.5 Able to follow instructions in English Exclusion Criteria: Hospitalization for exacerbation of MS within the previous 2 months Unstable heart, lung, or other physical conditions Current smoker Oral temperature greater than 100 degrees Fahrenheit Acute illness, such as infection, inflammation, ongoing chest pain, or short of breath with light activities Current neurological diseases other than MS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Hui Huang, PhD
Organizational Affiliation
University of Michigan-Flint
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Boston Home
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02124
Country
United States
Facility Name
University of Michigan-Flint
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis

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