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Telerehabilitation in Lung Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568564
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
esra pehlivan, Saglik Bilimleri Universitesi

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Major complication rate [ Time Frame: Up to 3 months ]
    Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Duration of tube thoracostomy drainage [ Time Frame: Up to 3 months ]
  5. 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).

  6. 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).

  7. Diffusion Capacity [ Time Frame: Change from baseline to 1 and 3 months ]
    DLCO and DLCO / VA values will be analyzed

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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%.

  18. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: Esra Pehlivan, Assoc.Prof. fztesrakambur@yahoo.com
Contact: Akif Turna, Prof.Dr. 90 (212) 414 32 52 akif.turna@gmail.com

Locations
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Turkey
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Thoracic Surgery Clinic Recruiting
İstanbul, Turkey, 34668
Contact: Akif Turna, Prof.Dr.       akif.turna@gmail.com   
Sponsors and Collaborators
Istanbul Medipol University Hospital
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Responsible Party: esra pehlivan, Principal investigator, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier: NCT04568564    
Other Study ID Numbers: PostopTele
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by esra pehlivan, Saglik Bilimleri Universitesi:
exercise
videoconference
lung cancer
surgery
postoperative
chest physiotherapy
telerehabilitation
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases