Telerehabilitation in Lung Surgery Patients
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|ClinicalTrials.gov Identifier: NCT04568564|
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : October 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Physiotherapy||Other: Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation Other: Exercise booklet||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Telerehabilitation of Reduced Physiotherapy Service in SARS-CoV-2 Pandemic Process in Lung Surgery Patients|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2021|
Experimental: Telerehabilitation Group (TG)
Patients diagnosed with lung cancer and underwent thoracotomy
Other: Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation
The exercise program includes breathing exercises (chest-abdominal-lateral basal breathing; 10 repetitions), use of intensive spirometry (20 repetitions) and assisted coughing. Apart from this, a progressive mobilization program will be applied considering patient tolerance and hemodynamic parameters, starting after the patient is taken to the service room. The teleconference exercise call will be continued from the postop 1st day until discharge, twice a day.
Active Comparator: Control group (CG)
Patients diagnosed with lung cancer and underwent thoracotomy
Other: Exercise booklet
Patients will be interviewed by videoconferencing method at least 1 day before the operation, their first evaluation will be taken and an exercise booklet will be given.
- Major complication rate [ Time Frame: Up to 3 months ]Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.
- The six-minute walking test [ Time Frame: Up 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.
- Modified Medical Research Council Dyspnea Scale [ Time Frame: Up 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.
- Visual analog scale [ Time Frame: Up 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
- Duration of tube thoracostomy drainage [ Time Frame: Up to 3 months ]
- Forced expiratory volume one second (FEV1) [ Time Frame: Up to 3 months ]FEV1 measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FEV1measured/ FEV1 predicted).
- Forced vital capacity (FVC) [ Time Frame: Up to 3 months ]FVC measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FVCmeasured/ FVC predicted).
- Diffusion Capacity [ Time Frame: Change from baseline to 1 and 3 months ]DLCO and DLCO / VA values will be analyzed
- Lung Capacities [ Time Frame: Change 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.
- Lung V/Q Scintigraphy [ Time Frame: Change from baseline to 1 and 3 months ]Tumor side and contralateral lung V / Q scintigraphy measurements will be made.
- Procalcitonin (PCT) [ Time Frame: 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) [ Time Frame: 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
- Ferritin [ Time Frame: Up 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.
- Lactate dehydrogenase [ Time Frame: Up 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.
- D'dimer test [ Time Frame: Up 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 Carbon monoxide Pressure (PaCO2) [ Time Frame: 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.
- Partial Oxigen Pressure (PaO2) [ Time Frame: 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.
- Arterial blood oxygen saturation level (SaO2) [ Time Frame: Up to 3 months ]It reflects the saturation level of hemoglobin with oxygen. Its normal values are 95-100%.
- Anxiety inventory [ Time Frame: Up 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568564
|Contact: Esra Pehlivan, Assoc.Prof.||firstname.lastname@example.org|
|Contact: Akif Turna, Prof.Dr.||90 (212) 414 32 email@example.com|
|Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Thoracic Surgery Clinic||Recruiting|
|İstanbul, Turkey, 34668|
|Contact: Akif Turna, Prof.Dr. firstname.lastname@example.org|