Cycle-ergometer in the Postoperative of Thoracic Surgery (CE_PTS)

August 21, 2017 updated by: Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre

Cycle-ergometer in the Postoperative of Thoracic Surgery: A Randomized, Controlled Clinical Trial Comparing the Effect of Interval Training With Continuous Training on Performance in the Six-minute Walk Test

Post-lateral thoracotomies and assisted thoracic surgery (CTVA) are the main surgical approaches for pulmonary resections. One of the counterpoints of these surgical approaches is postoperative pain, which in addition to causing ventilatory changes and reduction of lung capacities, contributes to bed rest and consequent decrease in patients' functionality. These complications increase hospitalization time and hospital costs, being determinant factors for perioperative morbidity and mortality. In order to prevent these outcomes of reduce the functional capacity of patients, new physiotherapeutic approaches have been adopted, such as the use of the cycloergometer. Recent studies show that the early use of this device brings benefits such as: improved blood circulation and venous return, increased muscle strength, improved functional capacity and reduced symptoms of dyspnea and fatigue. This study aims to compare the effect of interval training with continuous cycle ergometer training on performance in the six-minute walk test. Randomized and controlled clinical trial performed with patients submitted to elective thoracic surgery, hospitalized at the intensive care unit (ICU) and in the hospitalization unit of the Hospital Pavilhão Pereira Filho of the Santa Casa de Misericórdia Brotherhood of Porto Alegre. Participants will be randomized into three groups: control group (CG), interval exercise group (GHG) and continuous exercise group (GEC). Functional capacity assessments will be performed through the six-minute walk test (6MWT) and the chair sit and lift (TSL) test in 30 seconds, and evaluation of the clinical state of fatigue through the revised Piper-Fatigue Scale. The evaluations will be performed preoperatively and at hospital discharge.

Study Overview

Status

Status

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

Conditions

Conditions

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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

Will include patients between 30 and 80 years of age, of both sexes, submitted to thoracic surgery with incision by posterolateral thoracotomy, as well as those submitted to video-assisted thoracic surgery for pulmonary resection (bulectomy, segmentectomy, lobectomy, pneumectomy).

The cycloergometer rehabilitation program will be performed twice a day for 20 minutes.

The expectation of comparing two different types of muscle overload (interval training versus continuous training) is that the training of shorter duration and greater load also has a greater demand on the cardiopulmonary system of these patients and, therefore, a better response to the functional capacity rehabilitation program of these individuals.

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.
135

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

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients submitted to thoracic surgery with postero-lateral thoracotomy incision, as well as those submitted to video-assisted thoracic surgery for pulmonary resection (bulectomy, segmentectomy, lobectomy, pneumectomy);
  • Subjects extubated;
  • Hemodynamically stable (mean arterial pressure (MAP) between 60 mmHg and 100 mmHg, heart rate (HR) between 50 bpm and 110 bpm
  • Peripheral oxygen saturation ≥ 90%;
  • With prescription for respiratory and motor physiotherapy.

Exclusion Criteria:

  • Individuals who are not extubated for up to 6 hours in the immediate postoperative period, who require a second procedure during the immediate postoperative period;
  • Alterations in cognitive function;
  • Severe and decompensated cardiac arrhythmias;
  • Hypotensive crisis;
  • Hemoptysis;
  • Chest bleeding requiring reintervention;
  • sepsis;
  • Need for reintubation;
  • Signs of ventilatory effort;
  • Acute renal failure;
  • Unstable angina or malignant arrhythmias;
  • Fever.
  • Fluid drainage greater than 300 ml in the first six hours
  • Or those who refuse to participate in the study.

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
  • Masking: NONE

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.
NO_INTERVENTION: Control Group
Control Group: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) and assessments at discharge
EXPERIMENTAL: Interval effort group
Interval effort group: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Active phase (high load) lasting 60 seconds, followed by an active recovery phase with light / moderate load (60% of the maximum load) lasting 4 minutes. The pedaling speed should be maintained between 30-60rpm. There will be 5 cycles that will total 20 minutes of physical effort, and assessments at discharge.
Other: Interval effort group
Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Active phase (high load) lasting 60 seconds, followed by an active recovery phase with light / moderate load (60% of the maximum load) lasting 4 minutes. The pedaling speed should be maintained between 30-60rpm. There will be 5 cycles that will total 20 minutes of physical effort, and assessments at discharge.
EXPERIMENTAL: Continuous effort group
Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Intensity used will be mild / moderate, ie 60% of the maximum load reached in the incremental test. The pedaling speed should be maintained between 30-60rpm. The execution time, from this exercise regime will be 20 minutes, and assessments at discharge.
Other: Continuous effort group
Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Intensity used will be mild / moderate, ie 60% of the maximum load reached in the incremental test. The pedaling speed should be maintained between 30-60rpm. The execution time, from this exercise regime will be 20 minutes, and assessments at discharge.

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
Maximum distance performed on six-minute test
Time Frame: 6 minutes
Walk in a 30m corridor
6 minutes

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
Maximum number of times you succeed lift and sit on the chair
Time Frame: 30 seconds
With your arms crossed against your chest, sit up and get up from the chair
30 seconds

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.
Federal University of Health Science of Porto Alegre

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.
Irmandade Santa Casa de Misericórdia de Porto Alegre

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 (ANTICIPATED)

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 26, 2017

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.
December 30, 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.
February 28, 2018

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).
July 21, 2017

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.
July 21, 2017

First Posted (ACTUAL)

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.
July 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

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.
August 22, 2017

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.
August 21, 2017

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.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • Cycle-ergometer- PTS 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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