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Effects of Physical Therapy on Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier:
NCT01074957
First received: February 22, 2010
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
  Purpose

Background: Although respiratory physiotherapy has been used in patients undergoing cardiac surgery, evidence lacks concerning its effectiveness. The aim of this study was to evaluate the efficacy of three physiotherapeutic protocols used to recover respiratory volumes in the postoperative period.

Methods: Thirty five patients were randomly allocated into three groups. Exercise group (E) was oriented to progressive mobilization. Incentive Spirometry group (IS) performed deep breathings using VoldyneTM, while Breath-Stacking group (BS) performed successive inspiratory efforts using a facial mask adapted to an unidirectional valve. Both BS and IS also performed progressive mobilization. Forced spirometry was carried out in the pre-operative period and from the first to the fifth postoperative day. Statistical analysis used student t-test and ANOVA, and the differences were considered significant when p<0.05.


Condition Intervention
Pulmonary Volumes After Cardiac Surgery
 Device: Incentive Spirometry
Device: Breath-Stacking Technique
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Physical Therapy on Pulmonary Volumes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centro Universitário Augusto Motta:

Primary Outcome Measures:
  • Respiratory volume [ Time Frame: First five postoperative days ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: November 2007
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Incentive Spirometry
Incentive Spirometry group (IS) was oriented to take a deep breathing through Voldyne 5000TM (Sherwood Medical; St Loius, MO, USA) from Functional Residual Capacity (FRC) to Total Lung Capacity (TLC).
 Device: Incentive Spirometry
Incentive Spirometry (IS) has been used extensively in postoperative period and consists of spontaneous deep breaths through a device which provides a visual feedback to maintain a maximum insuflation
Other Name: Voldyne
Active Comparator: Exercise group
Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day).
 Other: Exercise
Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day).
Other Name: Early mobilization
Active Comparator: Breath-Stacking
Breath-Stacking group (BS) performed successive inspiratory efforts using a facial mask adapted to an unidirectional valve
 Device: Breath-Stacking Technique
An one-way valve device to promote the summation of successive inspiratory volumes while expiration was avoided
Other Name: One-way inspiratory valve

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients were not included if any of the following criteria was present:

  • Informed consent could not be obtained
  • Could not perform the preoperative tests
  • Cognitive impairments to perform the IS
  • Intolerance to the use of BS mask

Exclusion Criteria:

Exclusion criteria included:

  • Hemodynamic complications (intraoperative myocardial infarction
  • Major blood loss
  • Marked hypotension
  • Reduced cardiac output requiring the use of an intra-aortic balloon pump or extraordinary use of medications) and intubation period longer than 72 hours following arrival in the intensive care unit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074957

Sponsors and Collaborators
Centro Universitário Augusto Motta
Investigators
Principal Investigator: Cristina M Dias, DSc Centro Universitário Augusto Motta
  More Information

No publications provided

Responsible Party: Cristina Márcia Dias, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT01074957     History of Changes
Other Study ID Numbers: UNISUAM, Mestrado UNISUAM
Study First Received: February 22, 2010
Last Updated: February 23, 2010
Health Authority: Brazil: National Committee of Ethics in Research

ClinicalTrials.gov processed this record on May 23, 2013