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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02109055
• Other study ID #: PILATESCRM1
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2014
• Last updated: April 8, 2014
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2014
• Source: Federal University of Health Science of Porto Alegre
• Contact: Rodrigo DM Plentz
• Phone: +55 (051) 91794399
• Email: roplentz[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	Rodrigo Della Méa Plentz	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of functional capacity		six days	No
Secondary	Evaluation of respiratory muscle strength		six days	No
Secondary	Evaluation of respiratory volumes and flows		six days	No
Secondary	Evaluation of peripheral muscle strength		six days	No