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NCT02710110 · ClinicalTrials.gov registry record · Early Phase 1
Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)
A Early Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT02710110: Completed Early Phase 1 study, sponsored by University of Florida.
NCT02710110 is a Early Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 50 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02710110, a Early Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4% of ALS mortality. Unfortunately, treatments to prolong and maintain these vital functions are currently lacking. Although the use of exercise in ALS is controversial, recent evidence suggests that mild to moderate intensity exercise applied early in the disease slows disease progression, improves motor function, preserves motor neuron number, reduces muscle hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of ALS and human clinical trials. This research study is designed to determine the impact of respiratory strength training on breathing, airway protection and swallowing in persons with Amyotrophic Lateral Sclerosis (ALS).
Primary Outcome
Maximum expiratory pressure is a measure of force generating capabilities as assessed by having subjects quickly inhale then rapidly blow out air into a handheld manometer (Micro Mouth Pressure Meter). Three trails will be performed and the highest will be used.
Interventions
- PROCEDURE Videofluoroscopic swallowing study
- PROCEDURE Pulmonary Function Testing
- DEVICE Micro Mouth Pressure Meter
- DEVICE PowerLung trainer
- OTHER Swallowing Quality of Life Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-02-07 |
| Phase | Early Phase 1 |
What the finished NCT02710110 record still lists
NCT02710110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Videofluoroscopic swallowing study is the first listed.
NCT02710110 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02710110 about?
NCT02710110 is a clinical study titled "Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)". Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4% of ALS mortality. Unfortu...
What is the current status of trial NCT02710110?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2016-04. Estimated completion is 2019-02-07.
What interventions are being tested in trial NCT02710110?
The interventions under investigation include: Videofluoroscopic swallowing study (PROCEDURE), Pulmonary Function Testing (PROCEDURE), Micro Mouth Pressure Meter (DEVICE), PowerLung trainer (DEVICE), Swallowing Quality of Life Questionnaire (OTHER).
Who is sponsoring clinical trial NCT02710110?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02710110's enrollment target sits among peer trials
50 493rd of 2000 higher than 1,467 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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