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CompletedNCT00873028Updated Apr 1, 2009

Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

A Phase 3 interventional study of In Hospital Cardiopulmonary Rehabilitation in Coronary Artery Disease, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-04-01.

Sponsored by Hospital de Clinicas de Porto Alegre · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Coronary Artery Disease

Keywords

  • Physical therapy
  • Inspiratory muscles
  • Exercise
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In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 20 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    1

    Other: In Hospital Cardiopulmonary 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.

Interventions

  • OtherIn 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

    Also known as: Cardiac rehabilitation, Phase one cardiac rehabilitation

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What researchers measure

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)

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Study locations

1 site
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 900035-903, Brazil
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References and documents

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. doi: 10.1016/j.ahj.2008.08.006. Epub 2008 Oct 5. PubMed 19061704 ↗
  • 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. PubMed 18060837 ↗
  • 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. PubMed 16487841 ↗
  • 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. PubMed 16358136 ↗
  • 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. PubMed 18716482 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00873028
Lead sponsor
Hospital de Clinicas de Porto Alegre
First posted
Apr 1, 2009
Start date
Aug 2004
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Apr 1, 2009

Study contacts

Ricardo Stein, MD.ScD.
principal investigator · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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