Thoracic SurgeryNCT07133672
Effect of Digital Physiotherapy Practice on Pulmonary Function, Muscle Strength, Quality of Life After Thoracic Surgery
A study testing Exercise in people with Thoracic Surgery, run by Bezmialem Vakif University.
Trial summary
Thoracic surgery is the primary intervention used in the treatment of diseases affecting the lungs, pleura, chest wall, and mediastinum. Postoperative changes occur in both lung functions and clinical symptoms due to the procedure itself and patient-related factors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent open thoracotomy
- Agreement to participate in the study
- Being between the ages of 18-75
- Having an internet connection at home and being able to participate in video-conference sessions via desktop-laptop computers, smartphones, electronic tablets, etc.
Who cannot join
- Pneumonectomy surgeries
- Having a cardiac, orthopedic, neurological or systemic disease that would prevent exercise
- Having mental, communication or behavioral disorders that would cause problems in understanding commands and questions or performing exercises.
- Participating in a pulmonary rehabilitation program before surgery
- Having been hospitalized for any pulmonary disease during the study
About this study
Official title: The Effect of Digital Physiotherapy Practices on Pulmonary Functions, Respiratory Muscle Strength, Functional Capacity, Upper Extremity Peripheral Muscle Strength and Quality of Life in Patients Undergoing Thoracic Surgery
Thoracic surgery is the primary intervention used in the treatment of diseases affecting the lungs, pleura, chest wall, and mediastinum. Postoperative changes occur in both lung functions and clinical symptoms due to the procedure itself and patient-related factors. After thoracic surgery, patients often experience reduced exercise tolerance and impaired respiratory functions, negatively affecting their participation in daily activities, functional levels, and quality of life. In open thoracotomies, the incision site, severed muscles, and the size of the incision can impact upper extremity and trunk functions. The aim of this study is to investigate the effects of physiotherapy applied through digital methods on respiratory functions, respiratory muscle strength, functional capacity, upper extremity muscle strength, and quality of life in patients who have undergone thoracic surgery.
Read the detailed description
Thoracic surgery is a primary intervention used in the treatment of diseases of the lungs, pleura, chest wall, and mediastinum. Following surgery, changes in lung function and associated clinical symptoms may occur due to both the surgical procedure itself and patient-specific factors, and these may present intraoperatively and/or postoperatively. These changes are primarily restrictive in nature and may include a characteristic reduction in lung volume, a decrease in functional residual capacity that may lead to atelectasis, slowed mucociliary clearance, gas exchange abnormalities, and especially reduced chest expansion on the operated side. Additionally, problems in surfactant production and diaphragmatic dysfunction may also arise. Furthermore, the use of surgical drains, the nature of the surgical procedure, the integrity of the remaining lung tissue after resection, and the limitations caused by enforced immobility can all contribute to the development of various postoperative complications. Preventing and/or managing these postoperative complications is essential for enabling the patient to return to functional life, reducing long-term healthcare utilization, and improving survival rates. For this reason, pulmonary rehabilitation is indicated after thoracic surgeries. One of the methods of delivering rehabilitation is telerehabilitation, which allows patients to access therapy remotely. In this study, however, the term Digital Physiotherapy, which is a more current and comprehensive term recommended by World Physiotherapy, will be used. In the literature review, it was observed that most postoperative studies following thoracic surgery focus on the in-hospital period, while studies conducted after discharge are usually of short duration. The aim of this study is to examine the effects of long-term physiotherapy delivered through digital methods following thoracic surgery.
- Conditions
- Thoracic Surgery
- Being tested
- Exercise, Standard care
- Keywords
- Physiotherapy, Thoracic surgery, Exercises
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise sessions will begin with flexibility exercises targeting the shoulder and neck regions. This will be followed by breathing exercises utilizing fundamental respiratory techniques. Extremity exercises will include movements focused on the upper extremities and trunk, with progression applied according to a pre-established plan. Each session will conclude with cool-down exercises. Additionally, patients will be encouraged to engage in regular walking on a weekly basis.
Standard careOther
Patients will receive education regarding the critical aspects to consider after hospital discharge. Standard postoperative care protocols will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Active comparator | During the initial face-to-face assessment session, patients will be provided with general information regarding key points to consider following thoracic surgery. Instruction on the proper techniques for performing breathing exercises will also be given. The exercise training sessions will be structured to include approximately 10 minutes of warm-up, around 30 minutes of goal-oriented exercises, and a final 10-minute cool-down period, resulting in a total average duration of 50 minutes per session. Receives: Other: Exercise |
| Control group | Active comparator | During the initial face-to-face assessment session, patients will be provided with general information regarding key points to consider following thoracic surgery. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
The volume of air exhaled during a full and strongest exhalation possible after a full inspiration, as measured by a spirometry device.
Measured: 12 weeks
Forced expiratory volume in 1 second (FEV1)
FEV1 is the expiratory volume in the first second of the FVC maneuver.
Measured: 12 weeks
Tiffeneau ratio (FEV1/FVC)
The FEV1/FVC represents the fraction of air a patient exhales in the first second. This measurement is crucial for detecting airflow obstruction.
Measured: 12 weeks
Peak expiratory flow (PEF)
Peak Expiratory Flow (PEF) is defined as a maximal expiratory flow generated during a simple maneuver using a peak flow meter via a mouthpiece.
Measured: 12 weeks
Respiratory Muscle Strength
Maximum inspiratory and expiratory pressures are measured using an intraoral pressure measuring device.
Measured: 12 weeks
Functional Capacity
Six-Minute Walking Test Distance measurement (in meter).
Measured: 12 weeks
Upper Extremity Peripheral Muscle Strength
Measurement of shoulder flexion and abduction muscle strength using an electronic hand dynamometer.
Measured: 12 weeks
Health Related Quality of Life
Saint George Respiratory Questionnaire Results. Scores range from 1 to 100. Higher scores mean worse health.
Measured: 12 weeks
Secondary outcomes (5)
Shoulder Joint Range of Motion Measurement
Change of shoulder flexion and abduction range of motion
Measured: 12 weeks
Trunk Lateral Flexion Flexibility
It is the measurement of the distance between the first and last points during lateral flexion of the trunk with a tape measure. (in centimeters)
Measured: 12 weeks
Chest Expansion
Evaluation of change in chest expansion. The largest differences between maximum inspiration and maximum expiration is recorded as chest expansion.
Measured: 12 weeks
Shoulder Pain
Assessment is made using the Shoulder Pain and Disability Index. Higher scores indicate more severe pain and greater disability.
Measured: 12 weeks
Sleep
Assessment is made using the Insomnia Severity Index. Scores range from 0-28. A score of 8 or above is considered insomnia.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Şahin, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133672
- Sponsor's protocol ID
- BVUaysegul001
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital Physiotherapy Practices on Pulmonary Functions, Respiratory Muscle Strength, Functional Capacity, Upper Extremity Peripheral Muscle Strength and Quality of Life in Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07133672
- Acronym / sponsor ID
- BVUaysegul001
- Conditions
- Thoracic Surgery
- Keywords
- Physiotherapy, Thoracic surgery, Exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 21 Aug 2025 (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.
Thoracic surgery is the primary intervention used in the treatment of diseases affecting the lungs, pleura, chest wall, and mediastinum. Postoperative changes occur in both lung functions and clinical symptoms due to the procedure itself and patient-related factors. After thoracic surgery, patients often experience reduced exercise tolerance and impaired respiratory functions, negatively affecting their participation in daily activities, functional levels, and quality of life. In open thoracotomies, the incision site, severed muscles, and the size of the incision can impact upper extremity and trunk functions. The aim of this study is to investigate the effects of physiotherapy applied through digital methods on respiratory functions, respiratory muscle strength, functional capacity, upper extremity muscle strength, and quality of life in patients who have undergone thoracic surgery.
Detailed description
Thoracic surgery is a primary intervention used in the treatment of diseases of the lungs, pleura, chest wall, and mediastinum. Following surgery, changes in lung function and associated clinical symptoms may occur due to both the surgical procedure itself and patient-specific factors, and these may present intraoperatively and/or postoperatively. These changes are primarily restrictive in nature and may include a characteristic reduction in lung volume, a decrease in functional residual capacity that may lead to atelectasis, slowed mucociliary clearance, gas exchange abnormalities, and especially reduced chest expansion on the operated side. Additionally, problems in surfactant production and diaphragmatic dysfunction may also arise. Furthermore, the use of surgical drains, the nature of the surgical procedure, the integrity of the remaining lung tissue after resection, and the limitations caused by enforced immobility can all contribute to the development of various postoperative complications. Preventing and/or managing these postoperative complications is essential for enabling the patient to return to functional life, reducing long-term healthcare utilization, and improving survival rates. For this reason, pulmonary rehabilitation is indicated after thoracic surgeries. One of the methods of delivering rehabilitation is telerehabilitation, which allows patients to access therapy remotely. In this study, however, the term Digital Physiotherapy, which is a more current and comprehensive term recommended by World Physiotherapy, will be used. In the literature review, it was observed that most postoperative studies following thoracic surgery focus on the in-hospital period, while studies conducted after discharge are usually of short duration. The aim of this study is to examine the effects of long-term physiotherapy delivered through digital methods following thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Active comparator | Other: ExerciseDuring the initial face-to-face assessment session, patients will be provided with general information regarding key points to consider following thoracic surgery. Instruction on the proper techniques for performing breathing exercises will also be given. The exercise training sessions will be structured to include approximately 10 minutes of warm-up, around 30 minutes of goal-oriented exercises, and a final 10-minute cool-down period, resulting in a total average duration of 50 minutes per session. |
| Control group | Active comparator | Other: Standard careDuring the initial face-to-face assessment session, patients will be provided with general information regarding key points to consider following thoracic surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent open thoracotomy
- Agreement to participate in the study
- Being between the ages of 18-75
- Having an internet connection at home and being able to participate in video-conference sessions via desktop-laptop computers, smartphones, electronic tablets, etc.
Key exclusion criteria (5 listed)
- Pneumonectomy surgeries
- Having a cardiac, orthopedic, neurological or systemic disease that would prevent exercise
- Having mental, communication or behavioral disorders that would cause problems in understanding commands and questions or performing exercises.
- Participating in a pulmonary rehabilitation program before surgery
- Having been hospitalized for any pulmonary disease during the study
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 |
|---|---|---|
| ExerciseExercise sessions will begin with flexibility exercises targeting the shoulder and neck regions. This will be followed by breathing exercises utilizing fundamental respiratory techniques. Extremity exercises will include movements focused on the upper extremities and trunk, with progression applied according to a pre-established plan. Each session will conclude with cool-down exercises. Additionally, patients will be encouraged to engage in regular walking on a weekly basis. | Other | Training group |
| Standard carePatients will receive education regarding the critical aspects to consider after hospital discharge. Standard postoperative care protocols will be implemented. | Other | Control group |
Primary outcome
Forced vital capacity (FVC)
Time frame: 12 weeks
The volume of air exhaled during a full and strongest exhalation possible after a full inspiration, as measured by a spirometry device.
Forced expiratory volume in 1 second (FEV1)
Time frame: 12 weeks
FEV1 is the expiratory volume in the first second of the FVC maneuver.
Tiffeneau ratio (FEV1/FVC)
Time frame: 12 weeks
The FEV1/FVC represents the fraction of air a patient exhales in the first second. This measurement is crucial for detecting airflow obstruction.
Peak expiratory flow (PEF)
Time frame: 12 weeks
Peak Expiratory Flow (PEF) is defined as a maximal expiratory flow generated during a simple maneuver using a peak flow meter via a mouthpiece.
Respiratory Muscle Strength
Time frame: 12 weeks
Maximum inspiratory and expiratory pressures are measured using an intraoral pressure measuring device.
Functional Capacity
Time frame: 12 weeks
Six-Minute Walking Test Distance measurement (in meter).
Upper Extremity Peripheral Muscle Strength
Time frame: 12 weeks
Measurement of shoulder flexion and abduction muscle strength using an electronic hand dynamometer.
Health Related Quality of Life
Time frame: 12 weeks
Saint George Respiratory Questionnaire Results. Scores range from 1 to 100. Higher scores mean worse health.
5 secondary outcomes
Shoulder Joint Range of Motion Measurement
Time frame: 12 weeks
Trunk Lateral Flexion Flexibility
Time frame: 12 weeks
Chest Expansion
Time frame: 12 weeks
Shoulder Pain
Time frame: 12 weeks
Sleep
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Thoracic Surgery, run by Bezmialem Vakif University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Forced vital capacity (FVC) (time frame: 12 weeks). The study lists 8 primary outcomes in all. 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 21 Aug 2025.