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CompletedNCT07532057PR-LUNGCA-2019Updated Apr 16, 2026

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

An interventional study of Supervised Pulmonary Rehabilitation and Home-Based Breathing Exercises in Cancer, Lung Neoplasms and Lung Cancer Small Cell Lung Cancer (SCLC), sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 5 months after the study started (first participant enrolled Nov 2018, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Cancer
  • Lung Neoplasms
  • Lung Cancer Small Cell Lung Cancer (SCLC)
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and after 8 weeks

  2. Forced Vital Capacity (FVC)

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

    Time frame: Baseline and Week 8

  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)

    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.

    Time frame: Baseline and after 8 weeks

  2. FEV1/FVC Ratio and FEF25-75%

    Time frame: Baseline and Week 8

  3. Mini-Mental State Examination (MMSE) Score

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

    Time frame: Baseline and Week 8

07

Study locations

1 site
  • Istanbul Medipol University
    Istanbul, Kavacik 34000, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07532057
Lead sponsor
Istanbul Medipol University Hospital
Collaborators
Halic University
Responsible party
dogukan kurc (Lecturer, Istanbul Medipol University Hospital) — Principal investigator
First posted
Apr 15, 2026
Start date
Nov 1, 2018
Primary completion
May 30, 2019
Completion
May 30, 2019
Last update
Apr 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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