Telerehabilitation in Lung Surgery Patients

Telerehabilitation of Reduced Physiotherapy Service in SARS-CoV-2 Pandemic Process in Lung Surgery Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Physiotherapy
• Intervention / Treatment: Other: Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation; Other: Exercise booklet

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Pehlivan, Assoc.Prof.; Email: fztesrakambur@yahoo.com
• Study Contact Backup: Name: Akif Turna, Prof.Dr.; Phone Number: +90 212 414 24 24; Email: akif.turna@gmail.com

Study Locations

• Turkey
  • İstanbul, Turkey, 34668
    • Recruiting
    • Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Thoracic Surgery Clinic
    • Contact: Akif Turna, Prof.Dr.; Email: akif.turna@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complication rate	Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The six-minute walking test	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.	Up to 3 months
Modified Medical Research Council Dyspnea Scale	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.	Up to 3 months
Visual analog scale	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	Up to 3 months
Duration of tube thoracostomy drainage		Up to 3 months
Forced expiratory volume one second (FEV1)	FEV1 measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FEV1measured/ FEV1 predicted).	Up to 3 months
Forced vital capacity (FVC)	FVC measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FVCmeasured/ FVC predicted).	Up to 3 months
Diffusion Capacity	DLCO and DLCO / VA values will be analyzed	Change from baseline to 1 and 3 months
Lung Capacities	Lung capacities will be given the measured value and their percentages will be calculated according to the estimated values.	Change from baseline to 1 and 3 months
Lung V/Q Scintigraphy	Tumor side and contralateral lung V / Q scintigraphy measurements will be made.	Change from baseline to 1 and 3 months
Procalcitonin (PCT)	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.	Up to 3 months
C-Reactive Protein (CRP)	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	Up to 3 months
Ferritin	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.	Up to 3 months
Lactate dehydrogenase	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.	Up to 3 months
D'dimer test	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.	Up to 3 months
Partial Carbon monoxide Pressure (PaCO2)	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.	Up to 3 months
Partial Oxigen Pressure (PaO2)	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.	Up to 3 months
Arterial blood oxygen saturation level (SaO2)	It reflects the saturation level of hemoglobin with oxygen. Its normal values are 95-100%.	Up to 3 months
Anxiety inventory	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.	Up to 3 months

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: exercise; lung cancer; surgery; postoperative; chest physiotherapy; telerehabilitation; videoconference
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: PostopTele

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No