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临床试验/NCT07441863
NCT07441863已完成不适用

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

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Length of Hospital Stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

盲法说明

No masking is applied in this study.

入排标准

年龄范围
45 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Comprehensive In-Patient Physiotherapy (CIPT) Program (Behavioral)

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.

干预措施: Comprehensive In-Patient Physiotherapy (CIPT) Program (Behavioral)

结局指标

主要结局

Length of Hospital Stay

时间窗: 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.

C-reactive protein (CRP)

时间窗: 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.

Peripheral Oxygen Saturation (SpO₂)

时间窗: 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.

次要结局

  • Neutrophil-to-Lymphocyte Ratio (NLR)(Postoperative Day 1 and at hospital discharge (up to 30 days after surgery))
  • Serum Albumin(Postoperative Day 1 and at hospital discharge (up to 30 days after surgery))
  • Systolic Blood Pressure(Postoperative Day 1 and at hospital discharge (up to 30 days after surgery))
  • Diastolic Blood Pressure(Postoperative Day 1 and at hospital discharge (up to 30 days after surgery))
  • Heart Rate(Postoperative Day 1 and at hospital discharge (up to 30 days after surgery))
  • Dyspnea Severity(Postoperative Day 1 and at hospital discharge (up to 30 days after surgery))
  • Fatigue Severity(Postoperative Day 1 and at hospital discharge (up to 30 days after surgery))
  • Incisional Pain Intensity(Postoperative Day 1 and at hospital discharge (up to 30 days after surgery))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Sena Manzak

Assistant Professor

Bezmialem Vakif University

研究点 (1)

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