Diaphragm Training Post-Cardiac Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00597298

Acronym

DIATRACS

Enrollment

Registered

2008-01-18

Start date

2008-01-31

Completion date

2009-01-31

Last updated

2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Paralysis

Keywords

diaphragmatic paralysis, cardiac surgery, respiratory muscle training

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.

Interventions

DEVICEThreshold

Inspiratory muscle training program using a variable pressure device. An inspiratory muscle training device comprises a chamber having an opening for the passage of air to be inhaled and exhaled, and an inlet permitting air to be inhaled to enter the chamber and to pass to the opening. A one-way exhaust valve permits exhaled air entering through the opening to escape from the chamber, and another valve is provided to resist the entry of air to be inhaled into the chamber, the latter valve serving to vary the degree of resistance in dependence upon the volume of air that has passed through the inlet.

DEVICEsham threshold

non-training physical activity

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* heart failure * COPD * neuromuscular disease

Design outcomes

Primary

Measure	Time frame
chest x-ray mobility of the diaphragm	6 and 12 months

Secondary

Measure	Time frame
Maximal inspiratory pressure (MIP), cm H2O	6 and 12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026