Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345199
• Other study ID #: PP-1703-27264
• Status: Completed
• Phase: N/A
• Start date: October 28, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Respiratory Aspiration
• Sclerosis

Intervention

Other:
• Inspiratory Muscle Trainer (IMT)
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.

Locations

Country	Name	City	State
United States	The Boston Home	Boston	Massachusetts
United States	University of Michigan-Flint	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 28 weeks
Primary	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.	Baseline to 28 weeks
Secondary	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	Baseline to 28 weeks
Secondary	Change in Activity Participation	The average number of recreational programs attended by each participant per day.	Baseline to 28 weeks
Secondary	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.	Baseline to 28 weeks