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

NCT ID: NCT02109055

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pilates

Intervention Type: OTHER

The exercise program will be held during the period of hospitalization for six days, often two to three sessions per day, totaling 12 sessions.

Convencional Physiotherapy

The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy.

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type: OTHER

The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy, twice daily, six days.

Interventions

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.

Intervention Type: OTHER

Conventional Physiotherapy

The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy, twice daily, six days.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Della Méa Plentz

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manoela H dos Reis, Graduated

Role: STUDY_CHAIR

Federal University of Health Science of Porto Alegre

Leonardo F Neves, Graduated

Role: STUDY_CHAIR

University of the Sinos Valley

Cinara Stein, Master

Role: STUDY_CHAIR

Federal University of Health Science of Porto Alegre

Mirelle Hugo, Undergrad

Role: STUDY_CHAIR

Federal University of Health Science of Porto Alegre

Aline Miozzo, Graduated

Role: STUDY_CHAIR

Universidade Federal de Santa Maria

Christian Coronel, Master

Role: STUDY_CHAIR

Instituto de Cardiologia do Rio Grande do Sul

Locations

Rodrigo Della Méa Plentz

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Rodrigo DM Plentz

Role: CONTACT

roplentz@yahoo.com.br

+55 (051) 91794399

Facility Contacts

Manoela Heinrichs

Role: primary

manoelaheinrichs@yahoo.com.br

+55 (051)91330208

Other Identifiers

PILATESCRM1

Identifier Type: -

Identifier Source: org_study_id