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NCT04224961 · ClinicalTrials.gov registry record · NA
Respiratory Muscle Training (RMT) in ALS
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04224961: Completed NA study, sponsored by Duke University.
NCT04224961 is a NA study that has completed, run by Duke University. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04224961, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
Twelve adults with ALS will participate in a study involving four 3-week cycles of progressive respiratory muscle training (RMT). The investigators will measure maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) weekly. The investigators will obtain the majority of measurements of MIP and MEP during web-based telehealth visits. Participants will be stratified into 2 groups based on baseline inspiratory muscle strength as determined by maximum inspiratory pressure (MIP): six participants with minimal to no respiratory weakness (i.e., MIP ≥ 70% predicted) and six participants with mild to moderate inspiratory weakness (i.e., MIP 40-70% predicted).
Primary Outcome
Safe, well-tolerated moderate intensity Respiratory Muscle Training (RMT) is in part defined as an RPE between 4-5 and \<6. The RPE is a way of measuring physical activity intensity level. Perceived exertion is how hard the participant feels like their body is working. 0 = rest, 1 = very easy, 2 = easy, 3 = moderate, 4 = somewhat hard, 5 = hard, 6 = harder, 7 = very hard, 8/9 = extremely hard, 10 = maximal.
Interventions
- DEVICE Respiratory Muscle Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2022-11-29 |
| Phase | NA |
What the finished NCT04224961 record still lists
NCT04224961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Respiratory Muscle Training is the first listed.
NCT04224961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04224961 about?
NCT04224961 is a clinical study titled "Respiratory Muscle Training (RMT) in ALS". Twelve adults with ALS will participate in a study involving four 3-week cycles of progressive respiratory muscle training (RMT). The investigators will measure maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) weekly. The investigators will obtain the majority of measurements...
What is the current status of trial NCT04224961?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2020-01-14. Estimated completion is 2022-11-29.
What interventions are being tested in trial NCT04224961?
The interventions under investigation include: Respiratory Muscle Training (DEVICE).
Who is sponsoring clinical trial NCT04224961?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04224961's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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