- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07441863
Structured Pulmonary Physiotherapy After Lung Cancer Surgery by Age Group
Age-Related Effects of a Structured Postoperative Pulmonary Physiotherapy Program After Lung Cancer Surgery: A Prospective Interventional Study
This prospective, single-arm interventional study aims to evaluate the effectiveness of a structured postoperative pulmonary physiotherapy program delivered by the research team in patients undergoing lung cancer surgery. The intervention consists of chest physiotherapy, bronchial hygiene techniques, early mobilization, and postural exercises applied under physiotherapist supervision during the postoperative hospital stay.
The primary outcome is length of hospital stay. Secondary outcomes include blood pressure, heart rate, oxygen saturation, fatigue, and dyspnea levels. Clinical outcomes will be analyzed according to age groups (45-59 years and 60-90 years) to determine potential age-related differences in response to the intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This interventional study aims to evaluate the effectiveness of a structured pulmonary physiotherapy program applied after lung cancer surgery across different age groups. Patients aged 45 years and older undergoing lung resection will be included and categorized into two age groups (45-60 years and ≥60 years) for subgroup analysis.
The structured postoperative pulmonary physiotherapy program is initiated in the early postoperative period and continued until hospital discharge. The program includes chest physiotherapy techniques, early mobilization, postural exercises, and incentive spirometry training. The intervention is delivered once daily under physiotherapist supervision, and participants are instructed to continue prescribed breathing, incentive spirometry, and mobilization exercises independently during the afternoon and evening sessions.
The primary outcome measure is length of hospital stay. Secondary outcomes include postoperative pain assessed by Visual Analog Scale (VAS), dyspnea and fatigue assessed by Borg scale, oxygen saturation, hemodynamic parameters, and inflammatory and biochemical markers including C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), albumin, prealbumin, creatine kinase (CK), and lactate dehydrogenase (LDH).
Clinical, physiological, and biochemical outcomes are assessed from the early postoperative period until hospital discharge. The study further aims to explore potential differences in treatment response between predefined age groups. No randomization or control group is included, as all participants receive the same structured physiotherapy intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Bezmialem Vakif University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 45 to 90 years
- Undergoing lung cancer surgery (lobectomy, segmentectomy, or pneumonectomy)
- Medically stable in the early postoperative period
- Able to participate in a structured pulmonary physiotherapy program
- Provided written informed consent
Exclusion Criteria:
- Hemodynamic instability preventing mobilization
- Severe cognitive impairment limiting cooperation
- Neurological or orthopedic conditions restricting mobilization
- Requirement for prolonged mechanical ventilation
- Presence of another active malignancy
- Any medical contraindication to physiotherapy as determined by the attending physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Postoperative Pulmonary Physiotherapy Group
Participants in this arm receive a structured postoperative pulmonary physiotherapy program delivered by the research team during the hospital stay following lung cancer surgery.
The program includes supervised chest physiotherapy, bronchial hygiene techniques, early mobilization, and postural exercises applied according to a standardized protocol.
All participants receive the same intervention; no comparison group is included.
|
The structured postoperative pulmonary physiotherapy program is delivered by the research team during the hospital stay following lung cancer surgery. The intervention is applied according to a standardized protocol and includes supervised chest physiotherapy techniques (deep breathing exercises, thoracic expansion exercises, airway clearance techniques, and incentive spirometry), early mobilization (progressive sitting, standing, and ambulation), and postural exercises. The program is administered once daily under physiotherapist supervision. In addition, participants are instructed to continue the prescribed breathing, incentive spirometry, and mobilization exercises independently during the afternoon and evening sessions. The intervention is initiated in the early postoperative period and continues until hospital discharge. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospital Stay
Time Frame: Postoperative period, from ward admission after surgery until hospital discharge (maximum 30 postoperative days)
|
Length of hospital stay is defined as the number of days from postoperative admission to the ward until hospital discharge following lung cancer surgery.
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Postoperative period, from ward admission after surgery until hospital discharge (maximum 30 postoperative days)
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C-reactive protein (CRP)
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Serum CRP levels (mg/L) will be measured to evaluate postoperative systemic inflammatory response.
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
|
Peripheral Oxygen Saturation (SpO₂)
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
Peripheral oxygen saturation (%) will be measured using pulse oximetry to assess postoperative oxygenation status.
|
Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neutrophil-to-Lymphocyte Ratio (NLR)
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
NLR will be calculated from complete blood count parameters to assess systemic inflammatory status.
|
Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
|
Serum Albumin
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
Serum albumin levels (g/dL) will be measured to assess nutritional status.
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Systolic Blood Pressure
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Systolic blood pressure (mmHg) will be recorded to assess postoperative hemodynamic response.
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
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Diastolic Blood Pressure
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Diastolic blood pressure (mmHg) will be recorded to assess postoperative hemodynamic response.
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
|
Heart Rate
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Heart rate (beats per minute) will be measured to evaluate cardiovascular response during the postoperative period.
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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|
Dyspnea Severity
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale (0-10), where 0 indicates "no breathlessness" and 10 indicates "maximal breathlessness."
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Fatigue Severity
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Fatigue will be assessed using the Borg Rating of Perceived Exertion (0-10), where higher scores indicate greater perceived fatigue.
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Incisional Pain Intensity
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Incisional pain will be evaluated using the Numeric Rating Scale (NRS, 0-10), where 0 represents "no pain" and 10 represents "worst imaginable pain."
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşe Sena Manzak Dursun, Assistant Professor, Bezmialem Vakif University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/72
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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