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Completed

NCT Number: NCT00873028

Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Clinicas de Porto Alegre

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Cardiac rehabilitation, Phase one cardiac rehabilitation

Primary outcomes

  1. 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)

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.

    Time frame: From 7 days after surgery up to 30 days after surgery (CABG)

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 1, 2009
Registry last updated
Apr 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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