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| Name | Class |
|---|---|
| Halic University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group (Pulmonary Rehabilitation Group) | Experimental | 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. |
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| Control Arm (Home Exercise Program Group) | Active Comparator | Unsupervised home-based programme of diaphragmatic breathing exercises and effective coughing techniques, twice daily for 8 weeks. No supervised sessions. No aerobic walking. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised Pulmonary Rehabilitation | Behavioral | 8-week, twice-daily programme supervised by a licensed physiotherapist. Components: (1) Postural drainage + diaphragmatic/thoracic breathing exercises (20 reps); (2) Manual bronchial clearance: percussion, vibration, shaking; (3) ACBT: breathing control → thoracic expansion exercises → forced expiration technique (huff); (4) Effective coughing manoeuvres; (5) Progressive resistance/strengthening exercises (upper and lower limbs); (6) Home aerobic walking: 20 min/day at Borg RPE 11-13/20. Session stopped if SpO2 < 88%. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Capacity (6-Minute Walk Test - 6MWT) | The 6MWT was used to evaluate functional exercise capacity. The change in walking distance after 8 weeks was compared between the two groups. | Baseline and after 8 weeks |
| Forced Vital Capacity (FVC) | FVC (litres) by spirometry (COSMED), ATS/ERS standards, best of three. | Baseline and Week 8 |
| Forced Expiratory Volume in 1 Second (FEV1) | Baseline and Week 8 | |
| Peak Expiratory Flow (PEF) | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (Lung Cancer Symptom Scale - LCSS) | The LCSS questionnaire was used to assess patients' symptom burden and quality of life related to lung cancer. The difference in scores from baseline to post-intervention was analyzed. | Baseline and after 8 weeks |
| FEV1/FVC Ratio and FEF25-75% |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Istanbul | Kavacik | 34000 | Turkey (Türkiye) |
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| Home-Based Breathing Exercises | Behavioral | Patients in this group received breathing exercises and effective coughing techniques as part of a home-based rehabilitation program. The intervention included: Breathing exercises Effective coughing techniques Patients were instructed to perform these exercises twice daily at home for 8 weeks without physiotherapist supervision. |
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| Baseline and Week 8 |
| Mini-Mental State Examination (MMSE) Score | Cognitive screening (inclusion cutoff ≥24/30); post-intervention monitoring for chemotherapy-associated cognitive effects. | Baseline and Week 8 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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