Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis



Status:Active, not recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:2/23/2019
Start Date:October 28, 2017
End Date:April 1, 2019

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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.

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.

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
We found this trial at
2
sites
2049 Dorchester Avenue
Boston, Massachusetts 02124
Phone: 617-825-3905
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Boston, MA
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Flint, Michigan 48502
Phone: 810-762-3373
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Flint, MI
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