Neuromuscular DiseaseRMSTNCT01555905
Respiratory Muscle Strength in Patients With NMD
A study testing Threshold PEP or IMT device Phillips-Respironics in people with Neuromuscular Disease, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine if inspiratory muscle strength training (IMST) will impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease. Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Neuromuscular Disease
- What is being tested?
- Threshold PEP or IMT device Phillips-Respironics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of neuromuscular disease
- Clinical evidence of impaired pulmonary function
Who cannot join
- Above or below age range
- No clinical evidence of impaired pulmonary function
- No diagnosis of a neuromusuclar disease
- Presence of an acute illness at time of study
- Participating in other research studies involving investigational drugs
- Diagnosis of a primary pulmonary disease
- Use of tobacco products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease
The purpose of this study is to determine if inspiratory muscle strength training (IMST) will impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease.
Read the detailed description
Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.
- Conditions
- Neuromuscular Disease
- Being tested
- Threshold PEP or IMT device Phillips-Respironics
- Keywords
- Respiratory Muscle Strength
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold PEP or IMT device Phillips-RespironicsDevice
The subject will be instructed to take 8-15 deep, forceful breaths through the Threshold device, followed by at least 3 minutes of rest. The process will be repeated 3 more times for a total of 4 sets of 8-15 breaths. IMST will be completed three to five days per week, based upon the subject's daily baseline level of fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Threshold PEP or IMT device Phillips-Respironics Receives: Device: Threshold PEP or IMT device Phillips-Respironics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure
The primary endpoints for inspiratory muscle training efficacy will be maximal inspiratory pressure tests, a measure of respiratory strength.
Measured: Baseline (pre-IMST) and 3 months (post-IMST)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionMar 2022
- Study completionMar 2022
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara K Smith, PhD, PT, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555905
- Sponsor's protocol ID
- IRB201600270
- Acronym
- RMST
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2012
- Last updated
- 16 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease
- ClinicalTrials.gov ID
- NCT01555905
- Acronym / sponsor ID
- RMST / IRB201600270
- Conditions
- Neuromuscular Disease
- Keywords
- Respiratory Muscle Strength
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Posted 16 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if inspiratory muscle strength training (IMST) will impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease.
Detailed description
Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Device: Threshold PEP or IMT device Phillips-RespironicsThreshold PEP or IMT device Phillips-Respironics |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of neuromuscular disease
- Clinical evidence of impaired pulmonary function
Key exclusion criteria (7 listed)
- Above or below age range
- No clinical evidence of impaired pulmonary function
- No diagnosis of a neuromusuclar disease
- Presence of an acute illness at time of study
- Participating in other research studies involving investigational drugs
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 |
|---|---|---|
| Threshold PEP or IMT device Phillips-RespironicsThe subject will be instructed to take 8-15 deep, forceful breaths through the Threshold device, followed by at least 3 minutes of rest. The process will be repeated 3 more times for a total of 4 sets of 8-15 breaths. IMST will be completed three to five days per week, based upon the subject's daily baseline level of fatigue. | Device | Exercise |
Primary outcome
Maximal Inspiratory Pressure
Time frame: Baseline (pre-IMST) and 3 months (post-IMST)
The primary endpoints for inspiratory muscle training efficacy will be maximal inspiratory pressure tests, a measure of respiratory strength.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Barbara K Smith, PhD, PT principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold PEP or IMT device Phillips-Respironics in people with Neuromuscular Disease, run by University of Florida at 1 site 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 16 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximal Inspiratory Pressure (time frame: Baseline (pre-IMST) and 3 months (post-IMST)). 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 16 May 2023.