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NCT Number: NCT07532057

The Effect of Pulmonary Rehabilitation on Pulmonary Function Tests, Exercise Capacity, and Quality of Life in Patients With Advanced-Stage Lung Cancer Receiving Chemotherapy

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).

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Key information

Conditions

Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Cancer Small Cell Lung Cancer (SCLC) Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Kavacik, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%.

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.

Primary outcomes

  1. Change in Exercise Capacity (6-Minute Walk Test - 6MWT)

    Time frame: 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.

  2. Forced Vital Capacity (FVC)

    Time frame: Baseline and Week 8

    FVC (litres) by spirometry (COSMED), ATS/ERS standards, best of three.

  3. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline and Week 8

  4. Peak Expiratory Flow (PEF)

    Time frame: Baseline and Week 8

Secondary outcomes

  1. Change in Quality of Life (Lung Cancer Symptom Scale - LCSS)

    Time frame: 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.

  2. FEV1/FVC Ratio and FEF25-75%

    Time frame: Baseline and Week 8

  3. Mini-Mental State Examination (MMSE) Score

    Time frame: Baseline and Week 8

    Cognitive screening (inclusion cutoff ≥24/30); post-intervention monitoring for chemotherapy-associated cognitive effects.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Collaborators

  • Halic University

Registry information

Official study title

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

Acronym: PR-LUNGCA-2019

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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