Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: In Hospital Cardiopulmonary Rehabilitation

• Registration Number: NCT00873028
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential association with improved functional capacity after coronary artery bypass grafting surgery.

Detailed Description

Eligible patients were randomized to a cardiopulmonary rehabilitation program (Rehab; n = 10) or to usual care (Control; n = 10). The randomization was done by the Graphpad StatMate computerized program. Those patients assigned to Control were followed by their own physicians, received routine nursing assistance, were visited daily by the one of the investigators (CPM), but were not exposed to any specific respiratory or motor physical intervention. Those randomized to Rehab received the same medical and nursing care, but followed a structured physical therapy program twice a day.

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-31
• Last Update Submitted: 2009-03-31
• Study First Posted: 2009-04-01
• Last Update Posted: 2009-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Previous history of more than one vessel coronary artery disease
• Lifelong abstinence from tobacco
• Formal indication for CABG

Exclusion Criteria

• Patients older than 75 years of age
• Chronic renal failure (dialysis for more than 3 months)
• Unstable angina in the 48 hours prior to CABG
• Moderate or severe valve disease
• Complex cardiac arrhythmia's
• Stroke
• Inability to exercise the lower limbs
• Previous pulmonary disease (forced vital capacity [FVC] < 80% of predicted and/or forced expiratory volume in 1 s [FEV1] < 70% of predicted)
• Previous history of asthma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	In Hospital Cardiopulmonary Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery).	From 1 day before surgery up to 30 days after surgery (CABG)

Secondary Outcome Measures

Name	Time	Method
Six-minute walk test (6MWT) was performed 7 days after surgery, and maximal cardiopulmonary exercise testing (CPET) was performed 30 days after CABG.	From 7 days after surgery up to 30 days after surgery (CABG)

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil