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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 is a Early Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 50 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02710110
The ClinicalTrials.gov registry entry for NCT02710110 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Videofluoroscopic swallowing study is the first listed.
NCT02710110 reports 0 study locations.
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.
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