Multiple SclerosisNCT03345199
Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis
A study testing Inspiratory Muscle Trainer (IMT) in people with Multiple Sclerosis, run by University of Michigan at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Inspiratory Muscle Trainer (IMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2017to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of The Boston Home
- Diagnosis of multiple sclerosis by a physician
- Expanded Disability Status Scale >6.5
- Able to follow instructions in English
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Boston Home
Boston, Massachusetts, 02124
University of Michigan-Flint
Flint, Michigan, 48502
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Inspiratory Muscle Trainer (IMT)
- Keywords
- Multiple Sclerosis, Inspiratory Muscle Training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Trainer (IMT) | Experimental | Inspiratory Muscle Trainer (IMT) provides resistance as a person inhales, thereby strengthening respiratory muscles. Receives: Other: Inspiratory Muscle Trainer (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 28 weeks
Secondary outcomes (3)
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
Measured: Baseline to 28 weeks
Change in Activity Participation
The average number of recreational programs attended by each participant per day.
Measured: Baseline to 28 weeks
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.
Measured: Baseline to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start28 Oct 2017
- Primary completion31 Dec 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Min-Hui Huang, University of Michigan
- Investigators
- Min-Hui Huang, PhD, Principal investigator, University of Michigan-Flint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345199
- Sponsor's protocol ID
- PP-1703-27264
- Status last verified
- Apr 2019
- First submitted
- 13 Nov 2017
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Persons With Advanced Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03345199
- Acronym / sponsor ID
- PP-1703-27264
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Inspiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Trainer (IMT) | Experimental | Other: Inspiratory Muscle Trainer (IMT)Inspiratory Muscle Trainer (IMT) provides resistance as a person inhales, thereby strengthening respiratory muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Residents of The Boston Home
- Diagnosis of multiple sclerosis by a physician
- Expanded Disability Status Scale >6.5
- Able to follow instructions in English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Inspiratory Muscle Trainer (IMT) |
Primary outcome
Change in Maximal inspiratory Pressure (MIP)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Change in Fatigue
Time frame: Baseline to 28 weeks
Change in Activity Participation
Time frame: Baseline to 28 weeks
Change in Respiratory Infection Incidents
Time frame: Baseline to 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Hui Huang, PhD principal investigator
University of Michigan-Flint
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Trainer (IMT) in people with Multiple Sclerosis, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal inspiratory Pressure (MIP) (time frame: Baseline to 28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.