Cancer, Lung Cancer Small Cell Lung Cancer (SCLC), Lung Neoplasms
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALSupervised Pulmonary Rehabilitation
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%.
BEHAVIORALHome-Based Breathing Exercises
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.
Sponsors
Istanbul Medipol University Hospital
Halic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Capacity (6-Minute Walk Test - 6MWT) | 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) | Baseline and Week 8 | FVC (litres) by spirometry (COSMED), ATS/ERS standards, best of three. |
| Forced Expiratory Volume in 1 Second (FEV1) | Baseline and Week 8 | — |
| Peak Expiratory Flow (PEF) | Baseline and Week 8 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (Lung Cancer Symptom Scale - LCSS) | Baseline and after 8 weeks | 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. |
| FEV1/FVC Ratio and FEF25-75% | Baseline and Week 8 | — |
| Mini-Mental State Examination (MMSE) Score | Baseline and Week 8 | Cognitive screening (inclusion cutoff ≥24/30); post-intervention monitoring for chemotherapy-associated cognitive effects. |
Countries
Turkey (Türkiye)
Outcome results
None listed