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NCT00856518 · ClinicalTrials.gov registry record · Phase 2

Expiratory Muscle Training for Persons With Neurodegenerative Disease

A Phase 2 study, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 2
Development phase
42
Enrollment target

NCT00856518: Completed Phase 2 study, sponsored by VA Office of Research and Development.

NCT00856518 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00856518, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 2
Development phase
42 participants
Enrollment target

Study Summary

Respiratory difficulty is one of the primary factors leading to death in patients with Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating diseases that cause difficulties in breathing, airway protection and swallowing. Patients with PD and MS typically become sedentary and lose endurance, maximal fitness levels and overall pulmonary function. Much of the research focus has been on the motor symptoms of PD and MS yet the pulmonary and swallowing complications are perhaps ultimately the most important disability as the diseases progress. The inability to generate adequate respiratory pressure is responsible for reduced cough magnitudes and cough response times. Cough is critical for the clearance of foreign materials in the airway helping to reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough function an increased risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are a number of promising outcomes from an expiratory strength-training program. By increasing expiratory muscle strength and expiratory pressure generation, effective breathing, clearance of the airway, and improved swallowing can occur. These explicit outcomes are predicted based on our experience with the use of an innovative device-driven, home-based expiratory strength training program focused on the expiratory muscles of respiration. This project focuses on following patients with PD and MS for an initial 5 weeks of strength training and them testing the outcome of a caregiver program for maintaining treatment effects.

Primary Outcome

Expiratory pressure generating capacity assessed via handheld manometer.

Interventions

  • DEVICE Sham
  • DEVICE EMST

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2009-03
Est. Completion 2014-08
Phase Phase 2
VA Office of Research and Development

1,668 total trials

What the finished NCT00856518 record still lists

NCT00856518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.

NCT00856518 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00856518 about?

NCT00856518 is a clinical study titled "Expiratory Muscle Training for Persons With Neurodegenerative Disease". Respiratory difficulty is one of the primary factors leading to death in patients with Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating diseases that cause difficulties in breathing, airway protection and swallowing. Patients with PD and MS typically become...

What is the current status of trial NCT00856518?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2009-03. Estimated completion is 2014-08.

What interventions are being tested in trial NCT00856518?

The interventions under investigation include: Sham (DEVICE), EMST (DEVICE).

Who is sponsoring clinical trial NCT00856518?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00856518's enrollment target sits among peer trials

42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00856518, the US trial registry maintained by the National Library of Medicine. NCT00856518 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.