Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

Coronary Artery Disease Clinical Trial

Official title:

Inspiratory Muscle Strength as a Determinant of Functional Capacity Early After Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873028
• Other study ID #: P1CRh
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2009
• Last updated: March 31, 2009
• Start date: August 2004
• Est. completion date: January 2006

Study information

• Verified date: March 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Respiratory Aspiration

Intervention

Other:
• In Hospital Cardiopulmonary Rehabilitation
The program consisted of bronchial hygiene characterized by detachment and removal of secretions and respiratory exercises which were applied in the respiratory muscles in order to strengthen and increase the resistance. Patients were instructed to maintain diaphragmatic breathing, at a rate of 12 to 18 breaths per minute during EPAP mask use, and the expiratory pressure was increased progressively in the following fashion: 3-8 cm H2O during 3-12 minutes. Also, they performed flexion/extension of hip and knee, active free exercises for upper limbs, ambulation exercise and ascent/descend of stairs

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Borghi-Silva A, Mendes RG, Costa Fde S, Di Lorenzo VA, Oliveira CR, Luzzi S. The influences of positive end expiratory pressure (PEEP) associated with physiotherapy intervention in phase I cardiac rehabilitation. Clinics (Sao Paulo). 2005 Dec;60(6):465-72 — View Citation

Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. Epub 2006 Jan 26. — View Citation

Haeffener MP, Ferreira GM, Barreto SS, Arena R, Dall'Ago P. Incentive spirometry with expiratory positive airway pressure reduces pulmonary complications, improves pulmonary function and 6-minute walk distance in patients undergoing coronary artery bypass — View Citation

Herdy AH, Marcchi PL, Vila A, Tavares C, Collaço J, Niebauer J, Ribeiro JP. Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery: a randomized controlled trial. Am J Phys Med Rehabil. 200 — View Citation

Hirschhorn AD, Richards D, Mungovan SF, Morris NR, Adams L. Supervised moderate intensity exercise improves distance walked at hospital discharge following coronary artery bypass graft surgery--a randomised controlled trial. Heart Lung Circ. 2008 Apr;17(2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No