Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis

NCT03345199 | Completed

• 1 other identifier: PP-1703-27264
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Inspiratory Muscle Training

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change in Fatigue

  Baseline to 28 weeks

• Change in Activity Participation

  Baseline to 28 weeks

• Change in Respiratory Infection Incidents

  Baseline to 28 weeks

Study Arms (1)

Inspiratory Muscle Trainer (IMT)

EXPERIMENTAL

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

Other: Inspiratory Muscle Trainer (IMT)

Interventions

Inspiratory Muscle Trainer (IMT) OTHER

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.

Inspiratory Muscle Trainer (IMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (2)

The Boston Home

Boston, Massachusetts, 02124, United States

Location

University of Michigan-Flint

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Min-Hui Huang, PhD

  University of Michigan-Flint

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: October 28, 2017
• Primary Completion: December 31, 2018
• Study Completion: April 1, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

US (2)