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

March 21, 2016 updated by: Maurice Zanini, Hospital de Clinicas de Porto Alegre

Evaluation of the Effects of Different Physical Therapy on Cardiac Rehabilitation in Post Operatory Period of Coronary Artery Bypass Graft: Randomized Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Porto Alegre Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline in functional capacity at seven days and thirty days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
capacity functional
Time Frame: evaluated 40 days after surgery
cardiopulmonary exercise testing ( VO2)
evaluated 40 days after surgery
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
Change from Baseline in respiratory muscle strength at seven days and thirty days after surgery
lung function
Time Frame: Change from Baseline in lung function at seven days and thirty days after surgery
assessed by spirometry (FVC and FEV1)
Change from Baseline in lung function at seven days and thirty days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • GPPG090650

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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