Clinical trial NCT03229070: Cycle-ergometer in the Postoperative of Thoracic Surgery
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
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Capacity
Fatigue
Dyspnea
Muscle Strength
Keywords: Thoracic Surgery
Postoperative Period
Rehabilitation
Early mobilization
Cycle-ergometer
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2017-07-25
Enrollment: 135
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum distance performed on six-minute test
timeFrame: 6 minutes
Secondary outcomes:
measure: Maximum number of times you succeed lift and sit on the chair
timeFrame: 30 seconds
Other outcomes:
Locations:
Study officials:
References: