Diaphragm Training Post-Cardiac Surgery

Not Applicable

Completed

• Conditions: Diaphragmatic Paralysis
• Interventions: Device: sham threshold; Device: Threshold

• Registration Number: NCT00597298
• Lead Sponsor: Ospedali Riuniti Trieste

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 Description

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-18
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• post-cardiosurgical diaphragmatic paralysis recent cardiosurgical intervention for by-pass and/or valve replacement

Exclusion Criteria

• heart failure
• COPD
• neuromuscular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	sham threshold	-
1	Threshold	inspiratory muscle training program using a pressure threshold device

Primary Outcome Measures

Name	Time	Method
chest x-ray mobility of the diaphragm	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Maximal inspiratory pressure (MIP), cm H2O	6 and 12 months

Trial Locations

Locations (1)

Fisiopatologia Respiratoria; 🇮🇹 Trieste, TS, Italy