Condition category
Respiratory
Date applied
29/10/2017
Date assigned
06/11/2017
Last edited
06/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic Obstructive Pulmonary Disease (COPD) is a term to describe lung diseases that can cause breathing problems. Pulmonary rehabilitation is a programme of exercise, education and support to help those with COPD be able to breathe and function. It is important for patients with COPD be able to function, especially if they are undergoing operations for their lung cancer or other respiratory diseases. The aim of the study is to examine the effectiveness of pulmonary rehabilitation on function, quality of life and tumours in patients with COPD.

Who can participate?
Patients aged 30 to 80 years old with COPD.

What does the study involve?
Participants undergo a pulmonary rehabilitation programme. This includes breathing training as well as practice 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. Participants are followed up at six and 12 months to assess their lung function, oxygen uptake, metabolism, complications and tumour response.

What are the possible benefits and risks of participating?
Participants may experience a positive effect on their cardiovascular system. There are no direct risks with participating in this study.

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?
June 2016 to December 2020

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

Who is the main contact?
Dr Janos Tamasa Varga

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janos Tamas Varga

ORCID ID

Contact details

National Koranyi Institute for Pulmonology
No 1
Piheno Street
Budapest
1121
Hungary
+36 208 081088
varga@koranyi.hu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EB 36/2016

Study information

Scientific title

The effectiveness of pulmonary rehabilitation on functional and quality of life parameters and tumor biological response in the PERIOPREPULMHAB study

Acronym

PERIOPREPULMHAB

Study hypothesis

What is the effectiveness of pulmonary rehabilitation on functional parameters, quality of life and tumour biology?

Ethics approval

Scientific Ethical Committee of the National Koranyi Institute, 30/11/2016, ref. No: 36/2016

Study design

Observational cross-sectional cohort single-centre study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Lung cancer, lung abscess, COPD, interstitial lung disease, tuberculosis

Intervention

This study tests the effectiveness of pulmonary rehabilitation on chest kinematics, lung mechanics, lung function, metabolism, peripherial and respiratory muscle function, exercise physiology, tumor biology. 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.

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 (6MWD) 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 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.

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 measuring the above functional and quality of life markers at start of the rehabilitation and end of the rehabilitation. and detecting the postoperative surgical complications in two weeks after thoracic operation. The functional and quality of life parameters and tumor biological response are measured six and 12 months after the operations.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Improvement of lung function is measured using spirometry the at end of rehabilitation and six and 12 months after the operation
2. Oxygen uptake is measured using the cardiopulmonary exercise test at the end of the rehabilitation and at 6 and 12 months after the operation
3. Metabolism at the end of the rehabilitation is measured using the cardiopulmonary exercise test at the end of the rehabilitation and at six and 12 months after the operation
4. Complications of the thoracic operation at 2 weeks after the thoracic surgery can be observed and at six and 12 months after the operation
5. Tumor biological response is measured using different analytical methods at six and 12 months after the operation

Secondary outcome measures

1. Chest kinematics is measured using thoracic circumference at the end of the rehabilitation and at 6 and 12 months after the operation
2. Lung mechanics is measured using lung function at the end of the rehabilitation and at 6 and 12 months after the operation
3. Peripheral and respiratory muscle function is measured using grip strength and peripherial muscle force measurement at the end of the rehabilitation and at 6 and 12 months after the operation
4. Quality of life is measured using CAT marker and mMRC at the end of the rehabilitation and at 6 and 12 months after the operation

Overall trial start date

01/07/2012

Overall trial end date

01/12/2023

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with COPD or interstitial lung disease
2. 30<Age<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

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

450 patients, 3 clusters, 150 patients in all cluster

Participant exclusion criteria

1. Inoperable lung cancer because of oncological staging
2. Not able to perform the pulmonary rehabilitation program because of joint disease
3. Not able to perform the pulmonary rehabilitation program because of psychological disorder

Recruitment start date

30/11/2016

Recruitment end date

30/11/2022

Locations

Countries of recruitment

Hungary

Trial participating centre

National Koranyi Institute for Pulmonology
No 1, Piheno Street
Budapest
1121
Hungary

Trial participating centre

Semmelweis University
Budapest, Üllői út 26
Budapest
1085
Hungary

Sponsor information

Organisation

National Koranyi Institute for Pulmonology

Sponsor details

No 1
Piheno Street
Budapest
1121
Hungary
+36 208 081088
varga@koranyi.hu

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

National Koranyi Institute for Pulmonology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are planing to have papers in Hungarian and international conferences in this topic and publish at least 3 publication in this field. The publications are planed to publish when the data are available. The date of the first planed publication is 04/2017.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Janos T. Varga, E-mail: varga@koranyi.hu, janosvargaster@gmail.com

Intention to publish date

28/04/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes