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Effects of Cardiac Rehabilitation on Postoperatory of Coronary Artery Bypass Graft.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01410253
First Posted: August 5, 2011
Last Update Posted: March 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maurice Zanini, Hospital de Clinicas de Porto Alegre
  Purpose
Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on recovery of functional capacity, pulmonary function and respiratory muscle strength in the period of hospital stay after coronary artery bypass graft.

Condition Intervention Phase
Complication of CABG Other: Combination of four techniques of physiotherapy Other: Combination of three techniques of physiotherapy Other: Combination of two techniques of physiotherapy Other: standard therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effects of Different Physical Therapy on Cardiac Rehabilitation in Post Operatory Period of Coronary Artery Bypass Graft: Randomized Clinical Trial.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • submaximal functional capacity [ Time Frame: Change from Baseline in functional capacity at seven days and thirty days after surgery ]
    functional capacity evaluated by six-minute walk test


Secondary Outcome Measures:
  • capacity functional [ Time Frame: evaluated 40 days after surgery ]
    cardiopulmonary exercise testing ( VO2)

  • respiratory muscle strength [ Time Frame: Change from Baseline in respiratory muscle strength at seven days and thirty days after surgery ]
    Both PImax and PEmax were obtained using a pressure transducer

  • lung function [ Time Frame: Change from Baseline in lung function at seven days and thirty days after surgery ]
    assessed by spirometry (FVC and FEV1)


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: March 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Other: Combination of four techniques of physiotherapy
The patients receive conventional physiotherapy, expiratory positive airway pressure, inspiratory muscle training and physical exercise. Twice daily for seven days
Experimental: Group 2 Other: Combination of three techniques of physiotherapy
Patients receive conventional physiotherapy, expiratory positive airway pressure and physical exercise. Twice daily for seven days
Experimental: Group 3 Other: Combination of two techniques of physiotherapy
Patients receive conventional physiotherapy,expiratory positive airway pressure respiratory muscle training. Twice daily for seven days
Placebo Comparator: Group 4 Other: standard therapy
Patients receive conventional physiotherapy and expiratory positive airway pressure. Twice daily for seven days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Patients are recruited from the waiting list for a first CABG intervention at the Porto Alegre Clinical Hospital.

Exclusion Criteria:

  • chronic renal failure,
  • unstable angina,
  • moderate or severe valve disease,
  • complex cardiac arrhythmia,
  • stroke,
  • inability to exercise the lower limbs,
  • subjects with forced expiratory volume in 1 second less than 70% of predicted
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410253


Locations
Brazil
Porto Alegre Clinical Hospital
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
  More Information

Responsible Party: Maurice Zanini, Msc., Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01410253     History of Changes
Other Study ID Numbers: GPPG090650
First Submitted: May 10, 2011
First Posted: August 5, 2011
Last Update Posted: March 22, 2016
Last Verified: March 2016