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

Primary Purpose

Functional Capacity, Fatigue, Dyspnea

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interval effort group
Continuous effort group
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Capacity focused on measuring Thoracic Surgery, Postoperative Period, Rehabilitation, Early mobilization, Cycle-ergometer

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control Group

    Interval effort group

    Continuous effort group

    Arm Description

    Control Group: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) and assessments at discharge

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Maximum distance performed on six-minute test
    Walk in a 30m corridor

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 21, 2017
    Last Updated
    August 21, 2017
    Sponsor
    Federal University of Health Science of Porto Alegre
    Collaborators
    Irmandade Santa Casa de Misericórdia de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03229070
    Brief Title
    Cycle-ergometer in the Postoperative of Thoracic Surgery
    Acronym
    CE_PTS
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 26, 2017 (Anticipated)
    Primary Completion Date
    December 30, 2017 (Anticipated)
    Study Completion Date
    February 28, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre
    Collaborators
    Irmandade Santa Casa de Misericórdia de Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Capacity, Fatigue, Dyspnea, Muscle Strength
    Keywords
    Thoracic Surgery, Postoperative Period, Rehabilitation, Early mobilization, Cycle-ergometer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    135 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Control Group: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) and assessments at discharge
    Arm Title
    Interval effort group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Continuous effort group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Interval effort group
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Continuous effort group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Maximum distance performed on six-minute test
    Description
    Walk in a 30m corridor
    Time Frame
    6 minutes
    Secondary Outcome Measure Information:
    Title
    Maximum number of times you succeed lift and sit on the chair
    Description
    With your arms crossed against your chest, sit up and get up from the chair
    Time Frame
    30 seconds

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cycle-ergometer in the Postoperative of Thoracic Surgery

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