- 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: An Ambispective Observational Cohort Study in Middle-aged and Older Patients
This ambispective observational cohort study aims to evaluate age-related differences in clinical outcomes among patients undergoing lung cancer surgery who received a structured comprehensive in-patient physiotherapy (CIPT) program as part of standard postoperative care. The CIPT program includes patient education, chest physiotherapy, breathing exercises, airway clearance techniques, early mobilization, postural exercises, and upper- and lower-extremity range-of-motion exercises during the postoperative hospital stay.
The primary outcome is hospital length of stay. Secondary outcomes include clinical parameters (blood pressure, resting heart rate, oxygen saturation, and respiratory rate), symptom-related outcomes (dyspnea, fatigue, and incisional pain), and inflammatory biomarkers (C-reactive protein, neutrophil-to-lymphocyte ratio, and albumin). Outcomes are analyzed according to predefined age groups (45-64 years and 65-90 years) to evaluate potential age-related differences.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This ambispective observational cohort study evaluates age-related differences in clinical outcomes among patients undergoing lung cancer surgery who received a structured comprehensive in-patient physiotherapy (CIPT) program as part of standard postoperative care. Patients aged 45-90 years were included and classified into two predefined age groups: middle-aged (45-64 years) and older (65-90 years).
The CIPT program was initiated on the first day after transfer from the intensive care unit to the thoracic surgery ward and continued until hospital discharge. The program included patient education, breathing exercises, incentive spirometry, airway clearance techniques, early mobilization, postural exercises, and upper- and lower-extremity range-of-motion exercises. One session per day was supervised by a physiotherapist, with additional sessions performed independently by the patient or with caregiver assistance during hospitalization.
The primary outcome was hospital length of stay. Secondary outcomes included clinical parameters (blood pressure, resting heart rate, oxygen saturation, and respiratory rate), symptom-related outcomes (dyspnea, fatigue, and incisional pain), and inflammatory biomarkers (C-reactive protein [CRP], neutrophil-to-lymphocyte ratio [NLR], and albumin).
Outcomes were assessed during the postoperative inpatient period and compared between the predefined age groups. No randomization or non-intervention control group was included, as all participants received the same structured CIPT program as part of standard postoperative care.
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
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Middle-aged group (45-64 years)
Participants aged 45-64 years who underwent lung cancer surgery and received the comprehensive in-patient physiotherapy (CIPT) program as part of standard postoperative care during hospitalization.
Outcomes were assessed during the postoperative inpatient period and compared with those of the older cohort.
|
The comprehensive in-patient physiotherapy (CIPT) program was provided as part of standard postoperative care following lung cancer surgery.
The program included patient education, breathing exercises, incentive spirometry, airway clearance techniques, early mobilization, postural exercises, and upper- and lower-extremity range-of-motion exercises.
It was initiated on the first day after transfer to the thoracic surgery ward and continued until hospital discharge.
One session per day was supervised by a physiotherapist, with two additional sessions performed independently by the patient or with caregiver assistance
|
|
Older group (65-90 years)
Participants aged 65-90 years who underwent lung cancer surgery and received the comprehensive in-patient physiotherapy (CIPT) program as part of standard postoperative care during hospitalization.
Outcomes were assessed during the postoperative inpatient period and compared with those of the middle-aged cohort.
|
The comprehensive in-patient physiotherapy (CIPT) program was provided as part of standard postoperative care following lung cancer surgery.
The program included patient education, breathing exercises, incentive spirometry, airway clearance techniques, early mobilization, postural exercises, and upper- and lower-extremity range-of-motion exercises.
It was initiated on the first day after transfer to the thoracic surgery ward and continued until hospital discharge.
One session per day was supervised by a physiotherapist, with two additional sessions performed independently by the patient or with caregiver assistance
|
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)
|
|
C-reactive protein (CRP)
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
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)
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NLR will be calculated from complete blood count parameters to assess systemic inflammatory status.
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Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
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|
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)
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Heart Rate
Time Frame: Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
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."
|
Postoperative Day 1 and at hospital discharge (up to 30 days after surgery)
|
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
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