Clinical Trial: Diaphragm Training Post-Cardiac Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis

Brief Summary: Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a program of diaphragm muscle training by means of the Threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.

Detailed Summary:

Inclusion criteria: All consecutive patients aged from 18 to 80 years old with RX-defined diaphragm paralysis post a major cardiosurgery intervention such as coronary bypass, valve substitution or both.

Exclusion criteria: Acute cardiac failure, COPD, chronic respiratory failure with indication to home oxygen therapy, neuromuscular diseases.

Outcome measures: MIP, MEP, diaphragm function recovery assessed by chest X-ray, lung function tests.

Sponsor: Ospedali Riuniti Trieste

Current Primary Outcome: chest x-ray mobility of the diaphragm [ Time Frame: 6 and 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Maximal inspiratory pressure (MIP), cm H2O [ Time Frame: 6 and 12 months ]

Original Secondary Outcome: Same as current

Information By: Ospedali Riuniti Trieste

Dates:
Date Received: January 9, 2008
Date Started: January 2008
Date Completion:
Last Updated: February 3, 2009
Last Verified: February 2009