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Telerehabilitation in Lung Surgery Patients

Not Applicable
Completed
Conditions
Physiotherapy
Lung Cancer
Interventions
Other: Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation
Other: Exercise booklet
Registration Number
NCT04568564
Lead Sponsor
Istanbul Medipol University Hospital
Brief Summary

In this study, providing access to physiotherapy applications by telerehabilitation method and the effectiveness of this application will be examined for patients who have undergone lung surgery in the early postoperative period during the pandemic process in which social isolation continues.

Detailed Description

* Patients who meet the inclusion criteria and agree to participate in the study will be included in the study.

* Patients diagnosed with lung cancer and underwent thoracotomy will be randomly divided into Telerehabilitation Group (TGR) and Control (KG) groups.

* Before the operation, enlightened and signed consent will be obtained from the cases, the first evaluations of the patients in both groups will be made and the first exercise training will be given to the telerehabilitation group.

* The study group will be followed up every day during their hospitalizations and the final tests of both groups will be made before discharge. Long-term follow-up will be carried out in the 1st month and 3rd month after discharge.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Having a smart phone and capable of making video calls,
  • Planned to be operated with thoracotomy or videothoracoscope,
  • Staged between IA and IIIB with clinical staging,
  • With proven lung tumor (If AC diagnosis is not confirmed after frozen or wedge, the patient will be excluded from the study),
  • Patients with no cardiac disease (ASA II or better) that affects their quality of life.
Exclusion Criteria
  • Having a cardiac disease that affects the quality of life,
  • Serious cognitive problems and presence of psychiatric diseases,
  • Presence of physical limitations (vision, hearing impairment, orthopedic problems).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Telerehabilitation Group (TG)Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulationPatients diagnosed with lung cancer and underwent thoracotomy
Control group (CG)Exercise bookletPatients diagnosed with lung cancer and underwent thoracotomy
Primary Outcome Measures
NameTimeMethod
Major complication rateUp to 3 months

Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.

Secondary Outcome Measures
NameTimeMethod
Visual analog scaleUp to 3 months

The pain, dyspnea and fatigue level of the cases were evaluated with visual analog scale (VAS) score. The scale presented as a 100 mm horizontal ruler is a documented method for scoring continuous soft data. "0" score means no pain, "100" means very severe pain

Diffusion CapacityChange from baseline to 1 and 3 months

DLCO and DLCO / VA values will be analyzed

Lung V/Q ScintigraphyChange from baseline to 1 and 3 months

Tumor side and contralateral lung V / Q scintigraphy measurements will be made.

Procalcitonin (PCT)Up to 3 months

Procalcitonin is a substance produced by many types of cells in the body, often in response to bacterial infections but also in response to tissue injury. The level of procalcitonin in the blood can increase significantly in systemic bacterial infections and sepsis.The reference value of PCT in adults and children older than 72 hours is 0. 15 ng/mL or less.

C-Reactive Protein (CRP)Up to 3 months

C-reactive protein is a substance produced by the liver in response to inflammation. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L). A test result showing a CRP level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease, which likely will require further testing to determine the cause

FerritinUp to 3 months

Ferritin is a blood protein that contains iron. The normal ferritin levels range from 12 to 300 nanograms per milliliter of blood (ng/mL) for males and 12 to 150 ng/mL for females.

D'dimer testUp to 3 months

D-dimer tests are used to help rule out the presence of an inappropriate blood clot (thrombus). The reference concentration of D-dimer is \< 250 ng/mL, or \< 0.4 mcg/mL.

Partial Oxigen Pressure (PaO2)Up to 3 months

The partial pressure of oxygen, also known as PaO2, is a measurement of oxygen pressure in arterial blood. 75 to 100 millimeters of mercury (mm Hg) is the normal ranges.

The six-minute walking testUp to 3 months

The six-minute walking test is an example of timed distance testing, widely used in clinical research and rehabilitation studies. According to the guidelines published by the American Thoracic Society, 6MWT is an easy-to-use, better tolerated test that reflects daily activities better than other walking tests. It can be applied in a short time. Requires little equipment. The six-minute walk test, used as a field test, is a simple and inexpensive test compatible with daily activities, which does not require exercise equipment. Before starting the test, the patient should rest for at least 10 minutes by sitting in the chair near the starting point. The walking area must be at least 30 m long. A shorter corridor causes more time to be spent for more frequent turns and changes of direction. With the help of stopwatch, it is kept for 6 minutes and the number of laps during the period is calculated and recorded. The functional capacity of the cases will be evaluated with 6MWT.

Duration of tube thoracostomy drainageUp to 3 months
Forced expiratory volume one second (FEV1)Up to 3 months

FEV1 measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FEV1measured/ FEV1 predicted).

Modified Medical Research Council Dyspnea ScaleUp to 3 months

It is a scale used to determine the severity of dyspnea with a rating of zero to 4. Zero means no dyspnea perception and 4 means severe dyspnea.

Forced vital capacity (FVC)Up to 3 months

FVC measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FVCmeasured/ FVC predicted).

Lung CapacitiesChange from baseline to 1 and 3 months

Lung capacities will be given the measured value and their percentages will be calculated according to the estimated values.

Lactate dehydrogenaseUp to 3 months

Lactate dehydrogenase is an enzyme that helps turn sugar into energy for your cells. High LDH levels could indicate cell damage.Normal LDH levels range from 140 units per liter (U/L) to 280 U/L or 2.34 microkatals/L to 4.68 microkatals/L.

Partial Carbon monoxide Pressure (PaCO2)Up to 3 months

The partial pressure of carbon dioxide (PCO2) is the measure of carbon dioxide within arterial or venous blood. It often serves as a marker of sufficient alveolar ventilation within the lungs. Generally, under normal physiologic conditions, the value of PCO2 ranges between 35 to 45 mmHg.

Arterial blood oxygen saturation level (SaO2)Up to 3 months

It reflects the saturation level of hemoglobin with oxygen. Its normal values are 95-100%.

Anxiety inventoryUp to 3 months

The state-trait anxiety scale will determine the anxiety levels of patients before and after surgery. It is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.While evaluating, a score between 1 (or -1) and 4 (or -4) is given for each item according to the positive or negative characteristics of the item, and the total score to be obtained is 50 constant is added. The highest score is 80, the lowest is 20. Total anxiety the higher the score, the more anxiety level of the person filling the scale.

Trial Locations

Locations (1)

Istanbul University-CerrahpaÅŸa, CerrahpaÅŸa Faculty of Medicine Thoracic Surgery Clinic

🇹🇷

İstanbul, Turkey

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