Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Inspiratory Muscle Trainer (IMT)

• Registration Number: NCT03345199
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2017-10-28
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Primary Completion: 2018-12-31
• Status Verified: 2019-04
• Study Completion: 2019-04-01
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Maximal inspiratory Pressure (MIP)	Baseline to 28 weeks	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)	Baseline to 28 weeks	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

Name	Time	Method
Change in Fatigue	Baseline to 28 weeks	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	Baseline to 28 weeks	The average number of recreational programs attended by each participant per day.
Change in Respiratory Infection Incidents	Baseline to 28 weeks	The total number of incidence of respiratory infection of each participant. All incidence of respiratory infection will be documented by nursing staff.

Trial Locations

Locations (2)

The Boston Home; 🇺🇸 Boston, Massachusetts, United States

University of Michigan-Flint; 🇺🇸 Flint, Michigan, United States