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Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00873028
First received: March 30, 2009
Last updated: March 31, 2009
Last verified: March 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Strength as a Determinant of Functional Capacity Early After Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

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
Experimental: 1 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
Other Names:
  • Cardiac rehabilitation
  • Phase one cardiac rehabilitation
No Intervention: 2
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
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:

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

Keywords provided by Hospital de Clinicas de Porto Alegre:
Physical therapy
Inspiratory muscles
Exercise

Additional relevant MeSH terms:
Respiratory Aspiration
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013