Application of Exercises Based on the Pilates in Coronary Artery Bypass Grafting
1 other identifier
interventional
30
1 country
1
Brief Summary
The major cause of mortality worldwide is due to cardiovascular diseases. A way to treat these diseases is coronary artery bypass grafting, one of the most common surgical procedures in the world. The incidence of post-operative complications contributes to functional decline of the patient, reduced quality of life and post-discharge mortality. Also, cardiac surgery leads to changes in lung capacity and respiratory muscle strength, causing a decrease in the function lung. Physical therapy proves to be an effective tool to combat changes resulting from cardiac surgery, demonstrating beneficial results in the pulmonary function, functional capacity, and peripheral and respiratory muscle strength. The Pilates method has been studied as a therapeutic way to healthy subjects and various kinds of diseases, but there are no studies in the literature evaluating the effect method in patients after coronary artery bypass surgery. The aim of this study is to investigate the effect of Pilates on functional capacity , flows and lung volumes, respiratory and peripheral muscle strength after coronary artery bypass grafting. Randomized clinical trial in which patients will be eligible after elective coronary artery bypass surgery, randomly allocated into two groups : conventional physiotherapy group (n = 15) and Pilates method associated with conventional physiotherapy group (n = 15). The outcomes will be assessed by blinded evaluator and data randomization will be performed through by electronic randomization.The interventions will take place during the length of stay in the hospital, totalizing a maximum of six days of intervention. It is expected that the application of the Pilates method exercise method associated with conventional physiotherapy in patients in postoperative coronary artery bypass grafting improves functional capacity, flows and lung volumes and respiratory and peripheral muscle strength.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Apr 2014
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
April 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 10, 2014
April 1, 2014
8 months
April 7, 2014
April 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of functional capacity
six days
Secondary Outcomes (3)
Evaluation of respiratory muscle strength
six days
Evaluation of respiratory volumes and flows
six days
Evaluation of peripheral muscle strength
six days
Study Arms (2)
Pilates
EXPERIMENTALRegarding upper limb exercises the limit of flexion and abduction less than 90°, with the exercises involving only the movement of flexion and extension of elbow shoulder will be respected. Along with patient data will be an exercise protocol based on the Pilates method that will be performed by a trained team of physiotherapists. Before and after the exercises the data of heart rate, blood pressure, oxygen saturation and subjective feeling of perceived exertion using the Modified Borg scale will be listed.
Convencional Physiotherapy
ACTIVE COMPARATORThe conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy.
Interventions
The exercise program will be held during the period of hospitalization for six days, often two to three sessions per day, totaling 12 sessions.
The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy, twice daily, six days.
Eligibility Criteria
You may qualify if:
- Individuals in postoperative coronary artery bypass grafting, extubated within 24 hours after surgery, hemodynamically stable, with no ischemic changes and/or complex arrhythmias on electrocardiogram e who have performed the first surgery and surgery alone.
You may not qualify if:
- Patients with decompensated heart failure, presence of any comorbidity, such as unstable angina, associated neurological disease, moderate to severe respiratory illness prior diagnosed by the attending physician, acute respiratory dysfunction in the post - operative, active infectious disease or fever; vascular disease disabling peripheral, unstable ventricular arrhythmia; musculoskeletal disease that limits the practice of Pilates will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rodrigo Della Méa Plentz
Porto Alegre, Rio Grande do Sul, 90050170, Brazil
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Manoela H dos Reis, Graduated
Federal University of Health Science of Porto Alegre
- STUDY CHAIR
Leonardo F Neves, Graduated
University of the Sinos Valley
- STUDY CHAIR
Cinara Stein, Master
Federal University of Health Science of Porto Alegre
- STUDY CHAIR
Mirelle Hugo, Undergrad
Federal University of Health Science of Porto Alegre
- STUDY CHAIR
Aline Miozzo, Graduated
Universidade Federal de Santa Maria
- STUDY CHAIR
Christian Coronel, Master
Instituto de Cardiologia do Rio Grande do Sul
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
April 7, 2014
First Posted
April 9, 2014
Study Start
April 1, 2014
Primary Completion
December 1, 2014
Study Completion
April 1, 2015
Last Updated
April 10, 2014
Record last verified: 2014-04