Application of Exercises Based on the Pilates in Coronary Artery Bypass Grafting

Application of Exercises Based on the Pilates Method on the Functional Capacity in Postoperative Surgery Coronery Artery Bypass Grafting: Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Pilates; Other: Conventional Physiotherapy

Detailed Description

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 intervention will start on the first day postoperatively. The program may not exceed 30% of maximum heart rate reserve of the patient that will be calculated by the Karvonen formula (Karvonen, Kentala et al., 1957). The exercises will be conducted at the patient's bedside, using light resistance springs representing the lowest possible burden of springs to be used in the Pilates method. The exercises will be performed on the upper limbs alternating between the left and right upper limb and likewise would run with the lower limbs by means of a protocol consists of four exercises until the limit of resistance of the patient or interrupt pre-established criteria.

One set of each exercise with a range of up to two minutes between exercises will be held. In the first three days of intervention 10 repetitions of each exercise and the remaining three days a total of 15 repetitions of each movement will be performed.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050170
      • Recruiting
      • Rodrigo Della Méa Plentz
      • Contact: Manoela Heinrichs; Phone Number: +55 (051)91330208; Email: manoelaheinrichs@yahoo.com.br
      • Sub-Investigator: Manoela Heinrichs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pilates; Regarding 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.	Other: Pilates; The exercise program will be held during the period of hospitalization for six days, often two to three sessions per day, totaling 12 sessions.
ACTIVE_COMPARATOR: Convencional Physiotherapy; The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy.	Other: Conventional Physiotherapy; The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy, twice daily, six days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of functional capacity	six days

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of respiratory muscle strength	six days
Evaluation of respiratory volumes and flows	six days
Evaluation of peripheral muscle strength	six days

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Instituto de Cardiologia do Rio Grande do Sul; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): April 1, 2015

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (ESTIMATE): April 9, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Thoracic Surgery; Exercise Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PILATESCRM1