Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass - Full Text View

Sponsored by:	Hospital de Clinicas de Porto Alegre
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00873028

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Other: In Hospital Cardiopulmonary Rehabilitation	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Inspiratory Muscle Strength as a Determinant of Functional Capacity Early After Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Exercise and Physical Fitness Rehabilitation Surgery

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery). [ Time Frame: From 1 day before surgery up to 30 days after surgery (CABG) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Six-minute walk test (6MWT) was performed 7 days after surgery, and maximal cardiopulmonary exercise testing (CPET) was performed 30 days after CABG. [ Time Frame: From 7 days after surgery up to 30 days after surgery (CABG) ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	August 2004
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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
2: No Intervention 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.

Arms

Assigned Interventions

1: Experimental

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

2: No Intervention

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.

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.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873028

Locations

Brazil, Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 900035-903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

Principal Investigator:

Ricardo Stein, MD.ScD.

Hospital de Clinicas de Porto Alegre

More Information

Publications:

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 graft surgery. Am Heart J. 2008 Nov;156(5):900.e1-900.e8. Epub 2008 Oct 5.

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):129-38. Epub 2007 Dec 3.

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.

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. 2005 Dec;60(6):465-72. Epub 2005 Dec 12.

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. 2008 Sep;87(9):714-9.

Responsible Party:	Hospital de Clinicas de Porto Alegre ( Ricardo Stein )
Study ID Numbers:	P1CRh
Study First Received:	March 30, 2009
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00873028 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:

Physical therapy
Inspiratory muscles
Exercise

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Benzocaine

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 02, 2009