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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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