NCT02109055

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

8 months

First QC Date

April 7, 2014

Last Update Submit

April 8, 2014

Conditions

Keywords

Cardiovascular DiseasesThoracic SurgeryExercise Therapy

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

EXPERIMENTAL

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

Convencional Physiotherapy

ACTIVE COMPARATOR

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

Other: Conventional Physiotherapy

Interventions

PilatesOTHER

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

Pilates

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

Convencional Physiotherapy

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • 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 CHAIR

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

Locations