Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery (PBCPT)

May 4, 2015 updated by: Mei-Wun Tsai, National Yang Ming University

Effects of Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery

The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy (CPT) for in-patients after cardiac surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Postoperative pulmonary and musculoskeletal complications are the most frequent and significant contributor to morbidity, mortality with hospitalization. Pilates-based exercise has be applied to improve core control, movement efficiency and postural stability. High incidence of musculoskeletal problems have been concerned in relation to the patient's functional recovery after cardiac surgery. However, no literature is addressed how to manage this issue effectively till now. The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy for in-patients after cardiac surgery. This is a single-blinded, randomized control trial. Investigators will enroll pre-cardiac surgery and allocate subjects to modified Pilates-based training group or control group using block randomization.The training protocol will be based on pilates concepts. The control group is treated with a conventional protocol of physical therapy. The study will be carried on whole in-patient phase. During this period, patients received respiratory motion analysis, chest wall muscles mobility, lung function and endurance evaluation. Patients' changes in respiratory movement, cardiopulmonary endurance, and lung function will be evaluated by an assessor blinded to the intervention at admission and discharge from hospital. After 6 months after hospital discharge, patient's respiratory motion, lung function and disease specific health related quality of life will be evaluated. All outcomes will be described by mean (SD) or number (%). Independent t test or chi square test will be used to compare the basic data difference between training group and conventional group. Then, two-way analysis of variance or two-way analysis of covariance will be used to compare the outcomes difference between groups. Alpha level is set at 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • post open heart surgery
  • FVC> 80% of predicted and/or FEV1>70% of predicted
  • age >/=20 years old
  • approve inform consent

Exclusion Criteria:

  • preoperative severe pulmonary hypertension
  • moderate to severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease
  • heart failure or s/p heart transplant
  • emergent surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates-based CPT
incorporated the concept of pilates training into cardiopulmonary physical therapy after cardiac surgery
Behavioral: Pilates-based CPT
To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery
Active Comparator: Traditional CPT
usual bed side cardiopulmonary physical therapy after cardiac surgery
Behavioral: Traditional CPT
A traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change from pre-operation in respiratory mechanics
Time Frame: at hospital discharge, an expected average of 2 weeks after surgery
Chest motion in deep breathing will be assessed simultaneously by 3D reality motion analysis and spirometer. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery.
at hospital discharge, an expected average of 2 weeks after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from pre-operation in respiratory mechanics
Time Frame: at 6 month after surgery
Chest motion in deep breathing will be assessed simultaneously by 3D reality motion analysis and spirometer. Participants will be followed at 6 month after surgery.
at 6 month after surgery
change from pre-operation in chest mobility
Time Frame: at hospital discharge, an expected average of 2 weeks after surgery
Chest mobility will be assessed by tape measuring the difference of chest circumference between deep inspiration and expiration. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery.
at hospital discharge, an expected average of 2 weeks after surgery
abnormal breathing pattern
Time Frame: at hospital discharge, an expected average of 2 weeks after surgery
Abnormal breathing pattern will be assessed by physical examination and camera recording if there is any paradoxical, asymmetrical chest movements during breathing. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery.
at hospital discharge, an expected average of 2 weeks after surgery
abnormal breathing pattern
Time Frame: at 6 month after surgery
Abnormal breathing pattern will be assessed by physical examination and camera recording if there is any paradoxical, asymmetrical chest movements during breathing. Participants will be followed at 6 month after surgery.
at 6 month after surgery
Percentage change from preoperative pulmonary function
Time Frame: at hospital discharge, an expected average of 2 weeks after surgery
Percentage of preoperative pulmonary function, including forced vital capacity (FVC), the first second forced expiratory volume (FEV1), peak inspiratory flow and peak expiratory flow are measured by spirometry at hospital discharge, an expected average of 2 weeks after cardiac surgery
at hospital discharge, an expected average of 2 weeks after surgery
Percentage change from preoperative pulmonary function
Time Frame: at 6 month after surgery
Percentage of preoperative pulmonary function, including forced vital capacity (FVC), the first second forced expiratory volume (FEV1), peak inspiratory flow and peak expiratory flow are measured by spirometry at 6 month after surgery
at 6 month after surgery
change of cardiopulmonary fitness
Time Frame: at hospital discharge, an expected average of 2 weeks after cardiac surgery
Six-minute walking test is used to assess cardiopulmonary fitness at hospital discharge, an expected average of 2 weeks after cardiac surgery.
at hospital discharge, an expected average of 2 weeks after cardiac surgery
cardiopulmonary exercise function
Time Frame: at one month after hospital discharge
Symptom-limited graded exercise testing is used to assess cardiopulmonary exercise function at one month after hospital discharge.
at one month after hospital discharge
health related quality of life
Time Frame: at 6 month after hospital discharge
Cardiovascular Limitations and Symptoms Profile (37 items) is used to assess disease specific health related quality of life at 6 month after hospital discharge.
at 6 month after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cheng-Hsin General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NationalYangMingU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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