The Effect of Pulmonary Rehabilitation on Pulmonary Function Tests, Exercise Capacity, and Quality of Life in Patients With Advanced-Stage Lung Cancer (Stage IIIB/IV) Receiving Chemotherapy: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Exercise Capacity (6-Minute Walk Test - 6MWT)
研究概览
简要总结
This randomised controlled trial investigated the effects of an 8-week physiotherapist-supervised pulmonary rehabilitation (PR) programme on pulmonary function tests (PFT), exercise capacity, and health-related quality of life (HRQoL) in patients with advanced-stage lung cancer (Stage IIIB/IV) receiving chemotherapy. Thirty patients were randomised to a PR group (n=15) or a home-programme control group (n=15). The PR group underwent twice-daily supervised sessions comprising postural drainage with breathing exercises, bronchial clearance techniques, active cycle of breathing technique (ACBT), effective coughing manoeuvres, and strengthening exercises - plus home aerobic walking 20 min/day. The control group performed home-based breathing and coughing exercises twice daily. Results: The PR group showed significant improvements in 6MWT (+85.8 m; p=0.001), FVC, FEV1, PEF (all p=0.001), and all 8 LCSS symptom domains (p=0.001). The control group showed significant declines in FEV1, PEF, 6MWT, and worsening quality of life. Between-group differences were significant for all primary outcomes (p≤0.001).
详细描述
BACKGROUND: Patients with advanced-stage lung cancer receiving chemotherapy experience progressive deterioration in pulmonary function, exercise capacity, and quality of life. Evidence for pulmonary rehabilitation during active chemotherapy remains limited. STUDY DESIGN: Prospective, single-centre, parallel-group randomised controlled trial. SETTING: Oncology Department, Yeditepe University Hospital, Istanbul, Turkey. ETHICS: Haliç University Ethics Committee (No: 109; 30.10.2018). Written informed consent obtained from all participants. NOTE ON REGISTRATION: This study was conducted November 2018 - May 2019, prior to routine implementation of prospective trial registration requirements. Registration completed retrospectively per ICMJE recommendations. INTERVENTION - PR GROUP (n=15): 8-week physiotherapist-supervised programme, twice daily: (1) postural drainage + breathing exercises ×20 reps; (2) bronchial clearance: percussion, vibration, shaking; (3) ACBT: breathing control → thoracic expansion → forced expiration; (4) effective coughing/huffing; (5) progressive strengthening. Home: same exercises 2×/day + aerobic walking 20 min/day. CONTROL GROUP (n=15): Home-based breathing exercises and effective coughing techniques, twice daily. No supervised sessions; no aerobic walking. OUTCOMES: Spirometry (COSMED: FVC, FEV1, PEF, FEF25-75%), 6MWT (30 m corridor, ATS), LCSS (9 domains, 100-mm VAS), MMSE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically confirmed lung cancer (any histological subtype), Stage IIIB or Stage IV Receiving or scheduled to receive chemotherapy (≤3 cycles completed at enrolment) Age ≥ 18 years ECOG Performance Status 0, 1, or 2 MMSE score ≥ 24/30 (adequate cognitive function) Written informed consent provided
排除标准
- •Lung cancer Stage I or II (operable disease) Any complication contraindicating pulmonary rehabilitation (including pathological bone fracture, open wound, unstable cardiac disease, active uncontrolled infection) Inability or refusal to provide written informed consent
研究组 & 干预措施
Treatment Group (Pulmonary Rehabilitation Group)
Physiotherapist-supervised pulmonary rehabilitation programme for 8 weeks, twice daily. Components: postural drainage with 20-rep breathing exercises, bronchial clearance techniques (percussion/vibration/shaking), ACBT, effective coughing/huffing, progressive strengthening exercises. Home programme: same exercises 2×/day + aerobic walking 20 min/day.
干预措施: Supervised Pulmonary Rehabilitation (Behavioral)
Control Arm (Home Exercise Program Group)
Unsupervised home-based programme of diaphragmatic breathing exercises and effective coughing techniques, twice daily for 8 weeks. No supervised sessions. No aerobic walking.
干预措施: Home-Based Breathing Exercises (Behavioral)
结局指标
主要结局
Change in Exercise Capacity (6-Minute Walk Test - 6MWT)
时间窗: Baseline and after 8 weeks
The 6MWT was used to evaluate functional exercise capacity. The change in walking distance after 8 weeks was compared between the two groups.
Forced Vital Capacity (FVC)
时间窗: Baseline and Week 8
FVC (litres) by spirometry (COSMED), ATS/ERS standards, best of three.
Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Baseline and Week 8
Peak Expiratory Flow (PEF)
时间窗: Baseline and Week 8
次要结局
- Change in Quality of Life (Lung Cancer Symptom Scale - LCSS)(Baseline and after 8 weeks)
- FEV1/FVC Ratio and FEF25-75%(Baseline and Week 8)
- Mini-Mental State Examination (MMSE) Score(Baseline and Week 8)
研究者
dogukan kurc
Lecturer
Istanbul Medipol University Hospital