Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

NCT00873028 | Completed Phase 3

• 1 other identifier: P1CRh
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Physical therapy; Inspiratory muscles; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

1

EXPERIMENTAL

Other: In Hospital Cardiopulmonary Rehabilitation

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.

Interventions

In Hospital Cardiopulmonary Rehabilitation OTHER

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

Also known as: Cardiac rehabilitation, Phase one cardiac rehabilitation

1

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 900035-903, Brazil

Location

Related Publications (5)

• 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. doi: 10.1016/j.ahj.2008.08.006. Epub 2008 Oct 5.

  PMID: 19061704 RESULT

• 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. doi: 10.1016/j.hlc.2007.09.004. Epub 2007 Dec 3.

  PMID: 18060837 RESULT

• 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. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.

  PMID: 16487841 RESULT

• 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. doi: 10.1590/s1807-59322005000600007. Epub 2005 Dec 12.

  PMID: 16358136 RESULT

• Herdy AH, Marcchi PL, Vila A, Tavares C, Collaco 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. doi: 10.1097/PHM.0b013e3181839152.

  PMID: 18716482 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Motor Activity

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ricardo Stein, MD.ScD.

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: April 1, 2009
• Study Start: August 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: April 1, 2009

Record last verified: 2009-03

Locations

BR (1)