The Effect of Pulmonary Rehabilitation on Pulmonary Function Tests, Exercise Capacity, and Quality of Life in Patients With Advanced-Stage Lung Cancer Receiving Chemotherapy (PR-LUNGCA-2019)

April 15, 2026 updated by: dogukan kurc, Istanbul Medipol University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Kavacik
      • Istanbul, Kavacik, Turkey (Türkiye), 34000
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Supervised 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%.
Active Comparator: 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.
Behavioral: Home-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 8 weeks
Forced Vital Capacity (FVC)
Time Frame: Baseline and Week 8
FVC (litres) by spirometry (COSMED), ATS/ERS standards, best of three.
Baseline and Week 8
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline and Week 8
Baseline and Week 8
Peak Expiratory Flow (PEF)
Time Frame: Baseline and Week 8
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 8 weeks
FEV1/FVC Ratio and FEF25-75%
Time Frame: Baseline and Week 8
Baseline and Week 8
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.
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Collaborators

Halic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HALIC-EC-109-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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