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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01410253
First received: May 10, 2011
Last updated: August 3, 2011
Last verified: August 2011
  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 Blind (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 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 ] [ Designated as safety issue: No ]
    functional capacity evaluated by six-minute walk test


Secondary Outcome Measures:
  • capacity functional [ Time Frame: evaluated 40 days after surgery ] [ Designated as safety issue: No ]
    cardiopulmonary exercise testing ( VO2)

  • respiratory muscle strength [ Time Frame: Change from Baseline in respiratory muscle strength at seven days and thirty days after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    assessed by spirometry (FVC and FEV1)


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maurice Zanini, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01410253     History of Changes
Other Study ID Numbers: GPPG090650
Study First Received: May 10, 2011
Last Updated: August 3, 2011
Health Authority: Brazil: National Committee of Ethics in Research

ClinicalTrials.gov processed this record on August 21, 2014