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Telerehabilitation in Lung Surgery Patients

Primary Purpose

Lung Cancer, Physiotherapy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation
Exercise booklet
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring exercise, videoconference, lung cancer, surgery, postoperative, chest physiotherapy, telerehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Thoracic Surgery ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation Group (TG)

Control group (CG)

Arm Description

Patients diagnosed with lung cancer and underwent thoracotomy

Patients diagnosed with lung cancer and underwent thoracotomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
Duration of tube thoracostomy drainage
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).
Forced vital capacity (FVC)
FVC measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FVCmeasured/ FVC predicted).
Diffusion Capacity
DLCO and DLCO / VA values will be analyzed
Lung Capacities
Lung capacities will be given the measured value and their percentages will be calculated according to the estimated values.
Lung V/Q Scintigraphy
Tumor side and contralateral lung V / Q scintigraphy measurements will be made.
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.
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
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.
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.
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.
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.
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.
Arterial blood oxygen saturation level (SaO2)
It reflects the saturation level of hemoglobin with oxygen. Its normal values are 95-100%.
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.

Full Information

First Posted
September 18, 2020
Last Updated
January 21, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04568564
Brief Title
Telerehabilitation in Lung Surgery Patients
Official Title
Telerehabilitation of Reduced Physiotherapy Service in SARS-CoV-2 Pandemic Process in Lung Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Physiotherapy
Keywords
exercise, videoconference, lung cancer, surgery, postoperative, chest physiotherapy, telerehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation Group (TG)
Arm Type
Experimental
Arm Description
Patients diagnosed with lung cancer and underwent thoracotomy
Arm Title
Control group (CG)
Arm Type
Active Comparator
Arm Description
Patients diagnosed with lung cancer and underwent thoracotomy
Intervention Type
Other
Intervention Name(s)
Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise booklet
Intervention Description
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 Measure Information:
Title
Major complication rate
Description
Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
The six-minute walking test
Description
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.
Time Frame
Up to 3 months
Title
Modified Medical Research Council Dyspnea Scale
Description
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.
Time Frame
Up to 3 months
Title
Visual analog scale
Description
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
Time Frame
Up to 3 months
Title
Duration of tube thoracostomy drainage
Time Frame
Up to 3 months
Title
Forced expiratory volume one second (FEV1)
Description
FEV1 measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FEV1measured/ FEV1 predicted).
Time Frame
Up to 3 months
Title
Forced vital capacity (FVC)
Description
FVC measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FVCmeasured/ FVC predicted).
Time Frame
Up to 3 months
Title
Diffusion Capacity
Description
DLCO and DLCO / VA values will be analyzed
Time Frame
Change from baseline to 1 and 3 months
Title
Lung Capacities
Description
Lung capacities will be given the measured value and their percentages will be calculated according to the estimated values.
Time Frame
Change from baseline to 1 and 3 months
Title
Lung V/Q Scintigraphy
Description
Tumor side and contralateral lung V / Q scintigraphy measurements will be made.
Time Frame
Change from baseline to 1 and 3 months
Title
Procalcitonin (PCT)
Description
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.
Time Frame
Up to 3 months
Title
C-Reactive Protein (CRP)
Description
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
Time Frame
Up to 3 months
Title
Ferritin
Description
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.
Time Frame
Up to 3 months
Title
Lactate dehydrogenase
Description
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.
Time Frame
Up to 3 months
Title
D'dimer test
Description
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.
Time Frame
Up to 3 months
Title
Partial Carbon monoxide Pressure (PaCO2)
Description
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.
Time Frame
Up to 3 months
Title
Partial Oxigen Pressure (PaO2)
Description
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.
Time Frame
Up to 3 months
Title
Arterial blood oxygen saturation level (SaO2)
Description
It reflects the saturation level of hemoglobin with oxygen. Its normal values are 95-100%.
Time Frame
Up to 3 months
Title
Anxiety inventory
Description
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.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Pehlivan, Assoc.Prof.
Email
fztesrakambur@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Akif Turna, Prof.Dr.
Phone
+90 212 414 24 24
Email
akif.turna@gmail.com
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Thoracic Surgery Clinic
City
İstanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akif Turna, Prof.Dr.
Email
akif.turna@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Telerehabilitation in Lung Surgery Patients

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