Lung CancerNCT04568564
Telerehabilitation in Lung Surgery Patients
A study testing Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation and Exercise booklet in people with Lung Cancer and Physiotherapy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Physiotherapy
- What is being tested?
- Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation and Exercise booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Thoracic Surgery Clinic
Istanbul, 34668
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Physiotherapy
- Being tested
- Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation, Exercise booklet
- Keywords
- exercise, videoconference, lung cancer, surgery, postoperative, chest physiotherapy, telerehabilitation
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulationOther
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.
Exercise bookletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group (TG) | Experimental | Patients diagnosed with lung cancer and underwent thoracotomy Receives: Other: Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation |
| Control group (CG) | Active comparator | Patients diagnosed with lung cancer and underwent thoracotomy Receives: Other: Exercise booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complication rate
Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.
Measured: Up to 3 months
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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
Measured: Up to 3 months
Duration of tube thoracostomy drainage
Measured: 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).
Measured: 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).
Measured: Up to 3 months
Diffusion Capacity
DLCO and DLCO / VA values will be analyzed
Measured: 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.
Measured: Change from baseline to 1 and 3 months
Lung V/Q Scintigraphy
Tumor side and contralateral lung V / Q scintigraphy measurements will be made.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568564
- Sponsor's protocol ID
- PostopTele
- Status last verified
- Apr 2025
- First submitted
- 18 Sep 2020
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation of Reduced Physiotherapy Service in SARS-CoV-2 Pandemic Process in Lung Surgery Patients
- ClinicalTrials.gov ID
- NCT04568564
- Acronym / sponsor ID
- PostopTele
- Conditions
- Lung Cancer, Physiotherapy
- Keywords
- exercise, videoconference, lung cancer, surgery, postoperative, chest physiotherapy, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group (TG) | Experimental | Other: Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulationPatients diagnosed with lung cancer and underwent thoracotomy |
| Control group (CG) | Active comparator | Other: Exercise bookletPatients diagnosed with lung cancer and underwent thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulationThe 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. | Other | Telerehabilitation Group (TG) |
| Exercise bookletPatients 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. | Other | Control group (CG) |
Primary outcome
Major complication rate
Time frame: Up to 3 months
Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.
18 secondary outcomes
The six-minute walking test
Time frame: Up to 3 months
Modified Medical Research Council Dyspnea Scale
Time frame: Up to 3 months
Visual analog scale
Time frame: Up to 3 months
Duration of tube thoracostomy drainage
Time frame: Up to 3 months
Forced expiratory volume one second (FEV1)
Time frame: Up to 3 months
Forced vital capacity (FVC)
Time frame: Up to 3 months
Diffusion Capacity
Time frame: Change from baseline to 1 and 3 months
Lung Capacities
Time frame: Change from baseline to 1 and 3 months
Lung V/Q Scintigraphy
Time frame: Change from baseline to 1 and 3 months
Procalcitonin (PCT)
Time frame: Up to 3 months
C-Reactive Protein (CRP)
Time frame: Up to 3 months
Ferritin
Time frame: Up to 3 months
Lactate dehydrogenase
Time frame: Up to 3 months
D'dimer test
Time frame: Up to 3 months
Partial Carbon monoxide Pressure (PaCO2)
Time frame: Up to 3 months
Partial Oxigen Pressure (PaO2)
Time frame: Up to 3 months
Arterial blood oxygen saturation level (SaO2)
Time frame: Up to 3 months
Anxiety inventory
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation and Exercise booklet in people with Lung Cancer and Physiotherapy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complication rate (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.