The Effect of Preoperative Structured Exercise Programme on Postoperative Pain Severity, Recovery Level, Discharge Time and Quality of Life in Patients With Non-Small Cell Lung Cancer: Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life (EQ-5D-5L)
研究概览
简要总结
INTRODUCTION: Lung cancer is among the leading cancers, and surgery has a major role in treatment. Patients diagnosed with Non-Small Cell Lung Cancer (NSCLC) who are eligible for surgical treatment have a high risk of experiencing postoperative complications. Therefore, in recent years, the concept of prehabilitation has begun to gain importance. Within the scope of prehabilitation practices, patients are provided with programmes that include aerobic exercises and breathing exercises in the preoperative period.
AIM: This study aims to evaluate the effects of a structured exercise programme, including aerobic exercises and breathing exercises in the preoperative period, on postoperative pain severity, surgical recovery level, length of hospital stays (LOS), and quality of life (QoL) in patients diagnosed with NSCLC and planned for surgical treatment.
METHODS: The research is an experimental, parallel group-randomised controlled trial to be conducted with 62 participants followed in the Thoracic Surgery Outpatient Clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital and scheduled for surgery due to NSCLC. Patients will be equally assigned to the intervention and control groups using the block randomization method. In the intervention group, in the preoperative period, for two weeks and five days per week, at least 30 minutes of walking per day will be performed; in addition, for two weeks before surgery, throughout the entire week, during waking hours, 10 repetitions with incentive spirometer every hour, and daily four sessions of deep breathing & coughing exercises will be performed as breathing exercises. In the control group, routine preoperative clinical procedures will be applied. In the postoperative period, pain severity, surgical recovery level, LOS, and QoL will be compared between the two groups. Data will be collected face-to-face by the researcher using the "Descriptive Characteristics Form", "EQ-5D-5L Quality of Life Scale", "Numeric Rating Scale (NRS)", and "Surgical Recovery Scale". Data on the length of hospital stay will be obtained from patient files. The data will be analysed using parametric and/or nonparametric tests through the SPSS.
CONCLUSION: The findings of the study are expected to contribute to strengthening holistic care approaches for the preoperative period in surgical nursing practices and to improving patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Ownership of a smartphone capable of tracking daily walking time.
- •Diagnosis of primary non-small cell lung cancer.
- •ASA (American Society of Anesthesiologists) classification I, II, or III.
- •Follow-up and treatment provided by the same surgical team.
- •No physical or cognitive impairment that would hinder participation in the study.
排除标准
- •Diagnosis of recurrent lung cancer.
- •Previous radiotherapy treatment prior to surgery.
- •Any condition preventing walking or exercise (orthopedic, neurological, cardiovascular, metastatic, etc.).
- •Diagnosis of additional respiratory system disease such as COPD, asthma, or emphysema preventing breathing exercises.
- •Inability to complete the two-week structured exercise programme due to surgery being scheduled earlier or later than planned.
- •Complications resulting in prolonged (>24 hours) intensive care unit stay after surgery.
- •Inability to discontinue or continue the structured exercise programme at any stage.
- •Refusal to participate in the study.
研究组 & 干预措施
Intervention Group
Prehabilitation (Structured Preoperative Exercise Programme)
干预措施: Prehabilitation (Structured Preoperative Exercise Programme) (Other)
Control Group
Control: Partients in this arm will receive standard preoperative care without a structured exercise programme. Study-related data will be collected from patients admitted to the hospital at the end of the two-week preoperative period in accordance with the study protocol. In this regard, the measurements to be taken in the study will include: (1) Pain severity: At 6, 12, 24 and 48 hours after surgery; (2) Surgical recovery level: On the third and seventh days after surgery; (3) Quality of life: On the first day before surgery and on the seventh day after surgery. (4) In addition, patients' LOSs will be recorded.
结局指标
主要结局
Health-Related Quality of Life (EQ-5D-5L)
时间窗: Change from baseline scores on the 7th postoperative day.
The EQ-5D-5L is a self-reported questionnaire assessing five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, mild problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a Visual Analog Scale (VAS) ranging from 0 (worst health) to 100 (best health) for participants to rate their current health status. Higher scores indicate better health.
Postoperative Pain Intensity (Numeric Rating Scale, NRS)
时间窗: Change from baseline scores on the 48 hours postoperatively.
The NRS is an 11-point scale (0-10) used to assess pain intensity, where 0 indicates no pain and 10 indicates the worst possible pain. Patients rate their pain at each time point, and the average of the measurements will be used to assess postoperative pain. The NRS is validated for adults, including elderly patients and those with mild-to-moderate cognitive impairment.
Postoperative Surgical Recovery (Surgical Recovery Scale)
时间窗: Change from baseline scores on the 7th postoperative day.
The Surgical Recovery Scale is a 13-item questionnaire assessing two sub-dimensions: "Impact on energy" and "Impact on daily activities." Items are scored using 6-point Likert scales, with higher scores indicating better recovery. The total score ranges from 8 to 73. This scale is validated with a Cronbach's α of 0.93.
次要结局
- Length of Hospital Stay(Approximately the seventh day.)
研究者
Burcu Duluklu
Asst. Prof.
Hacettepe University
