Pulmonary rehabilitation in COPD and interstitial lung diseases

ISRCTN	ISRCTN13019180
DOI	https://doi.org/10.1186/ISRCTN13019180
Protocol serial number	25/2017
Sponsor	National Koranyi Institute for Pulmonology
Funder	National Koranyi Institute for Pulmonology

Submission date: 19/12/2017
Registration date: 16/01/2018
Last edited: 05/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung diseases (ILD) are terms to describe lung diseases that can cause breathing problems. Pulmonary rehabilitation is a programme of exercise, education and support to help those with COPD and/or ILD to breathe and function. The aim of this study is to examine the effectiveness of pulmonary rehabilitation on function, systemic and oxidative stress markers and the quality of life of patients with COPD and/or ILD.

Who can participate?
Patients aged 30 to 80 with COPD or ILD

What does the study involve?
The pulmonary rehabilitation programme includes breathing training and controlled breathing techniques for 30 minutes in the morning as well as a personalised training program 2-3 times per day for 10-30 minutes using cycling and a treadmill in a format of continuous or interval training. The duration of the rehabilitation program is three weeks. All patients undergo tests including lung function testing and quality of life assessments at the start and the end of rehabilitation and after 6 and 12 months.

What are the possible benefits and risks of participating?
The possible benefits for patients participating in this study are improvement in heart and lung condition. The study is supervised by medical doctors, specialists and physiotherapists and there is a complete health check before participating. The program is absolutely safe for the patients.

Where is the study run from?
1. National Koranyi Institute for Pulmonology (Hungary)
2. Semmelweis University (Hungary)

When is the study starting and how long is it expected to run for?
July 2012 to December 2023

Who is funding the study?
National Koranyi Institute for Pulmonology (Hungary)

Who is the main contact?
Dr Janos Varga
varga.janos_tamas@med.semmelweis-univ.hu

Contact information

Dr Janos Tamas Varga
Scientific

No 1, Piheno Street
Budapest
H-1121
Hungary

Phone	+36 (0)208081088
Email	varga.janos_tamas@med.semmelweis-univ.hu

Study information

Primary study design	Observational
Study design	Observational cross-sectional cohort single-centre study
Secondary study design	Cross sectional study
Study type	Participant information sheet
Scientific title	The effectiveness of pulmonary rehabilitation in COPD and interstitial lung diseases
Study acronym	PULMREHABCOPDILD
Study objectives	What is the effectiveness of pulmonary rehabilitation on functional parameters, quality of life and systemic, oxidative stress parameters in COPD and ILD?
Ethics approval(s)	Ethics Committee of the National Koranyi Institute for Pulmonology, 17/11/2017, ref: 25/2017
Health condition(s) or problem(s) studied	COPD, interstitial lung diseases with or without pulmonary hypertension
Intervention	This study tests the effectiveness of pulmonary rehabilitation on chest kinematics, lung mechanics, lung function, metabolism, peripheral and respiratory muscle function, exercise physiology and systemic effect. The pulmonary rehabilitation programme includes breathing training and controlled breathing techniques for 30 minutes in the morning as well as a personalised training program 2-3 times per day for 10-30 minutes using a cycling and treadmill in a format of continuous or interval training. Pulmonary function programme includes the following: According to ATS/ERS guidelines all patients underwent post-bronchodilator pulmonary function testing (Vmax 229 and Autobox 6200, Sensormedics) including spirometry measurements. COPD patients inhaled 400 g salbutamol 20 minutes before testing. Functional follow-up and quality of life questionnaire Functional follow-up included complex assessment, measurement of lung functions, chest wall expansion, six minutes walking test (6MWT) and quality of life tests such as COPD Assessment Test (CAT) and Modified Medical Research Council Dyspnoea Scale (MMRC). Personalized training programs The pulmonary rehabilitation programme includes 30 minutes of respiratory training in the morning, chest wall mobilisation, learning the controlled breathing techniques, inhalation, expectoration, improving the psychological condition, smoking cessation and a personalized training. Patients participate in an individualized continuous or interval type of cycle- and/or treadmill training for 10-30 minutes, two-three times a day at a level of 60-80% of maximal intensity. The duration of the rehabilitation program is three weeks. The intensity of the training is progressive from 60-80% of peak work rate, the intensity was increased based on maintaining Borg dyspnoea scale breathlessness and leg fatigue both on grade No 7. Systemic and oxidative stress markers IL-6 and TNF-alfa in cytokines and malondialdehide and isoprostane-8 are measured before and after the rehabilitation and the observational period. Smoking cessation Smoking cessation is an important part of the perioperative rehabilitation program. Our institute has a special smoking cessation program for the patients once per week for 45 minutes, with help of psychologists. The plan is to measure the above functional, systemic and quality of life markers at start of the rehabilitation and end of the rehabilitation. The functional and quality of life parameters and tumor biological response are measured 6 and 12 months after the rehabilitation.
Intervention type	Mixed
Primary outcome measure(s)	1. Lung function is measured using spirometry at end of rehabilitation and at 6 and 12 months 2. Oxygen uptake is measured using the cardiopulmonary exercise test at the end of the rehabilitation and at 6 and 12 months 3. Metabolism at the end of the rehabilitation is measured using the cardiopulmonary exercise test at the end of the rehabilitation and at 6 and 12 months 4. Systemic inflammation is measured by routine laboratory methods for hsCRP, ELISA for cytokines, sputum and plasma concentration with HPLC at the end of rehabilitation, 6 and 12 months 5. Oxidative stress is measured by enzyme immunoassay techniques at the end of rehabilitation, 6 and 12 months
Key secondary outcome measure(s)	1. Chest kinematics is measured using thoracic circumference at the end of the rehabilitation and at 6 and 12 months 2. Lung mechanics is measured using lung function at the end of the rehabilitation and at 6 and 12 months 3. Peripheral and respiratory muscle function is measured using grip strength and peripheral muscle force measurement at the end of the rehabilitation and at 6 and 12 months 4. Quality of life is measured using CAT marker and mMRC at the end of the rehabilitation and at 6 and 12 months
Completion date	31/12/2023

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	30 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. Patients with COPD or interstitial lung disease 2. Age between 30 and 80 years 3. Able to perform respiratory training and endurance training 4. Able to understand the meaning of the program 5. Without significant psychological disease, which has influence the outcome of the rehabilitation
Key exclusion criteria	1. Not able to perform the pulmonary rehabilitation program because of joint disease 1. Not able to perform the pulmonary rehabilitation program because of psychological disorder
Date of first enrolment	18/11/2017
Date of final enrolment	31/12/2022

Locations

Countries of recruitment

Hungary

Study participating centres

National Koranyi Institute for Pulmonology

No 1, Piheno Street
Budapest
1121
Hungary

Semmelweis University

No 26, Ulloi Street
Budapest
H-1086
Hungary

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Janos T. Varga (janosvargaster@gmail.com). The data of the study will be available before publication until the end of the study. The data can be shared as a cooperative collaboration for meta-analysis after publication. All of the participants gave a written consent form and the data are anonymous.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		14/10/2021	21/10/2021	Yes	No
Results article		14/09/2022	29/09/2022	Yes	No
Results article		20/01/2023	05/02/2025	Yes	No
Results article		01/08/2020	05/02/2025	Yes	No
Results article		01/12/2018	05/02/2025	Yes	No
Results article		03/09/2021	05/02/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/02/2025: Publication references added.
08/02/2023: A contact email was updated.
29/09/2022: Publication reference added.
21/10/2021: Publication reference added.
09/07/2019: Internal review.