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Enrolling by invitation NCT07376161

Inflammation and Oxidative Stress in COPD

— Observational Inflamation COPD Oxidative Stress Pulmonary Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary Rehabilitation.
Who it may be relevant to
Registry conditions: Inflamation, COPD, Oxidative Stress, Pulmonary Rehabilitation. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Pulmonary Rehabilitation on Inflammation and Oxidative Stress in COPD

Overview

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, characterized by persistent airflow limitation, chronic inflammation, and increased oxidative stress. Despite optimal pharmacological treatment, many patients continue to experience symptoms, reduced exercise capacity, and frequent exacerbations. Pulmonary rehabilitation (PR) is an evidence-based, non-pharmacological intervention that improves symptoms, functional capacity, quality of life, and survival in patients with COPD; however, its biological effects on inflammatory and oxidative stress pathways remain insufficiently defined. This study aims to evaluate the effects of pulmonary rehabilitation on systemic inflammation and oxidative stress in patients with stable COPD. Serum levels of pro-inflammatory cytokines (interleukin-6 \[IL-6\], tumor necrosis factor alpha \[TNF-α\]) and the epithelial alarmin interleukin-33 (IL-33), which is released in response to airway epithelial injury, as well as nuclear factor erythroid 2-related factor 2 (NRF-2) gene and/or protein expression as a key regulator of antioxidant defense, will be measured before and after a standardized pulmonary rehabilitation program. By assessing changes in these biomarkers, this study seeks to determine whether pulmonary rehabilitation exerts disease-modifying effects beyond symptomatic improvement and functional outcomes. The findings are expected to provide novel insights into the biological mechanisms of pulmonary rehabilitation and to support its role as a targeted, cost-effective intervention in the comprehensive management of COPD.

Interventions

  • Behavioral Pulmonary Rehabilitation
    Participants will undergo a standardized, supervised pulmonary rehabilitation program consisting of exercise training, breathing exercises, and patient education. The program will include aerobic exercise training (treadmill or cycle ergometer), strength training of upper and lower limb muscles, and respiratory muscle training, conducted under the supervision of a multidisciplinary rehabilitation team. Sessions will be performed multiple times per week over a predefined program duration. The int

Primary outcome measures

  • Change in Inflammatory and Oxidative Stress Biomarkers After Pulmonary Rehabilitation in COPD Patients [Time frame: Baseline (before pulmonary rehabilitation) and after 8 weeks of pulmonary rehabilitation]
Secondary outcome measures (1)
  • Association Between Changes in Inflammatory and Oxidative Stress Biomarkers and Clinical and Functional Outcomes After Pulmonary Rehabilitation [Time frame: Baseline (before pulmonary rehabilitation) and after 8 weeks of pulmonary rehabilitation]

Eligibility criteria

Inclusion criteria

  • Adults aged 40-80 years with a diagnosis of stable COPD
  • Airflow limitation defined according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria (forced expiratory volume in 1 second / forced vital capacity \[FEV₁/FVC\] < 70% and forced expiratory volume in 1 second \[FEV₁\] < 70% predicted)
  • Former smokers with a smoking history of at least 10 pack-years
  • Clinically stable disease at the time of enrollment
  • Ability and willingness to participate in the pulmonary rehabilitation program
  • Provision of written informed consent

Exclusion criteria

  • Current smokers
  • History of acute COPD exacerbation or respiratory infection within the past 6 weeks
  • Presence of other chronic lung diseases (e.g., bronchiectasis, interstitial lung disease, asthma)
  • Active malignancy
  • Severe or uncontrolled cardiovascular disease, including recent acute myocardial infarction or malignant arrhythmias
  • Neurological, orthopedic, or psychiatric conditions that preclude objective functional assessment or participation in exercise training
  • Use of antioxidant or vitamin supplementation within the past 4 weeks
  • Determination by a cardiologist that participation in an exercise-based rehabilitation program is not medically appropriate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medeniyet University — Istanbul

Publications

  • Joppa P, Petrasova D, Stancak B, Dorkova Z, Tkacova R. Oxidative stress in patients with COPD and pulmonary hypertension. Wien Klin Wochenschr. 2007;119(13-14):428-34. doi: 10.1007/s00508-007-0819-y. PMID 17671825
  • Celli BR, Anzueto A, Singh D, Hanania NA, Fabbri L, Martinez FJ, Soler X, Djandji M, Jacob-Nara JA, Rowe PJ, Deniz Y, Radwan A. The Emerging Role of Alarmin-Targeting Biologics in the Treatment of Patients With COPD. Chest. 2025 May;167(5):1346-1355. doi: 10.1016/j.chest.2024.09.049. Epub 2024 Dec 2. PMID 39631681
  • Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, B PMID 24127811
  • Mosher CL, Nanna MG, Jawitz OK, Raman V, Farrow NE, Aleem S, Casaburi R, MacIntyre NR, Palmer SM, Myers ER. Cost-effectiveness of Pulmonary Rehabilitation Among US Adults With Chronic Obstructive Pulmonary Disease. JAMA Netw Open. 2022 Jun 1;5(6):e2218189. doi: 10.1001/jamanetworkopen.2022.18189. PMID 35731514
  • Pehlivan E, Yazar E, Balci A, Kilic L. Comparison of Compliance Rates and Treatment Efficiency in Home-Based with Hospital-Based Pulmonary Rehabilitation in COPD. Turk Thorac J. 2019 Jul 1;20(3):192-197. doi: 10.5152/TurkThoracJ.2019.18060. Print 2019 Jul. PMID 31479415
  • Pehlivan E, Yazar E, Balci A, Turan D, Demirkol B, Cetinkaya E. A comparative study of the effectiveness of hospital-based versus home-based pulmonary rehabilitation in candidates for bronchoscopic lung volume reduction. Heart Lung. 2020 Nov-Dec;49(6):959-964. doi: 10.1016/j.hrtlng.2020.06.011. Epub 2020 Jul 21. PMID 32709500
  • Ozmen I, Yildirim E, Ozturk M, Ocakli B, Yildiz R, Aydin R, Karakis M, Yilmaz O, Aksoy E. Pulmonary Rehabilitation Reduces Emergency Admission and Hospitalization Rates of Patients with Chronic Respiratory Diseases. Turk Thorac J. 2018 Sep 13;19(4):170-175. doi: 10.5152/TurkThoracJ.2018.17089. Print 2018 Oct. PMID 30322439
  • Pinho RA, Chiesa D, Mezzomo KM, Andrades ME, Bonatto F, Gelain D, Dal Pizzol F, Knorst MM, Moreira JC. Oxidative stress in chronic obstructive pulmonary disease patients submitted to a rehabilitation program. Respir Med. 2007 Aug;101(8):1830-5. doi: 10.1016/j.rmed.2007.02.004. Epub 2007 Mar 26. PMID 17376663

Identifiers

NCT: NCT07376161 · 23.10.2025; 2025/0255

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗