Forced oscillation as lung function test in pulmonary rehabilitation

ISRCTN	ISRCTN31987937
DOI	https://doi.org/10.1186/ISRCTN31987937
Secondary identifying numbers	2016/23/N/NZ7/0200

Submission date: 10/07/2020
Registration date: 23/07/2020
Last edited: 18/08/2023

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
Forced oscillation technique (FOT) is a type of lung function test, which permits to assess respiratory function. The advantage of FOT over conventional lung function techniques has already been proven for children and the elderly. In the project we plan to study the possibilities of using FOT in patients with different lung diseases admitted to the Pulmonary Rehabilitation Ward in Department of Lung Diseases and Tuberculosis in Zabrze, Medical University of Silesia, Poland.

Who can participate?
Patients with different lung diseases admitted to pulmonary rehabilitation ward

What does the study involve?
Patients will either undergo a three-week-long pulmonary rehabilitation program under physical therapist supervision or treatment as usual. The intensity of the training will be determined by the limit of heart rate obtained during a 6 minute walking test. Lung function tests and measurements of muscle strength will be performed before and after the program.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Medical University of Silesia (Poland)

When is the study starting and how long is it expected to run for?
December 2017 to December 2021

Who is funding the study?
National Science Centre in Poland (Narodowe Centrum Nauki)

Who is the main contact?
Sabina Kostorz-Nosal, kostorz.sabina@gmail.com

Contact information

Mrs Sabina Kostorz-Nosal
Scientific

Medical University of Silesia
Koziolka Street 1
Zabrze
41-803
Poland

ORCID ID	0000-0002-4844-0609
Phone	+48 662197798
Email	sabina.kostorz@med.sum.edu.pl

Mrs Sabina Kostorz-Nosal
Public

Koziolka Street 1
Zabrze
41-803
Poland

ORCID ID	0000-0002-4844-0609
Phone	+48 662197798
Email	kostorz.sabina@gmail.com

Study information

Study design	Single-centre interventional non-randomized study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The forced oscillation technique in patients with lung diseases subjected to pulmonary rehabilitation.
Study objectives	In the project we plan to study the possibilities of using the forced oscillation technique (FOT) in patients with different lung diseases subjected to pulmonary rehabilitation.
Ethics approval(s)	Approved 19/12/2017, Bioethics Committee of Medical University of Silesia (Poniatowskiego Street 15, Katowice, 40-055, Poland; +48 32 208 35 46; kombioet@sum.edu.pl), ref: KNW/0022/KB1/85/I/17
Health condition(s) or problem(s) studied	Lung diseases (idiopathic interstitial pneumonia, chronic obstructive pulmonary disease and patients after thoracic surgery)
Intervention	Lung function tests include: forced oscillation technique, spirometry and bodyplethysmography. All lung function tests will be evaluated before and after completing 3 weeks of pulmonary rehabilitation. All patients will perform also 6MWT and grip strength measurements of both hands. Afterwards all the results obtained before and after the rehabilitation program will be compared. The rehabilitation program will be performed 5 days per week and will include: - exercises on a stabilometric platform (biofeedback): once per day for 20 minutes - breathing exercises: three times per day for 10 minutes (inspiratory muscles training, toughening and strengthening of the diaphragm) - lumbar and cervical stabilization exercises and the equilibrium exercises: once per day for 20 minutes (PNF, strengthening of the abdominal muscles and shoulder girdle stabilization) - general rehabilitation gymnastics once per day for 30 minutes (the elements of stretching exercises, strengthening of the arms and legs and the correction of the body posture) - relaxation: once per day for 30 minutes (autogenic training, music therapy) - a cycle ergometer or a treadmill: once per day for 30 minutes in the range of training heart rate Control group will perform lung function tests (FOT, spirometry and plethysmography) in intervals of 3 weeks without pulmonary rehabilitation.
Intervention type	Behavioural
Primary outcome measure	1. Changes in FOT results (R5, R11, R19, X5, X11, X19, delta X, Fres, measured by oscillometer Resmon Pro Full device) - at baseline and after 3-week rehabilitation (study group)/3-week interval (control group) 2. Changes in distance in 6MWT- at baseline and after 3-week rehabilitation (study group)
Secondary outcome measures	1. Changes in lung plethysmography results (Raw, RV, TLC, measured by MedGraphic Plethysmograph)- at baseline and after 3-week rehabilitation (study group)/ 3-week interval (control group) 2. Changes in spirometry results (FEV1, FVC, FEV1/FVC, measured by spirometer LungTest 1000)- at beseline and after 3-week rehabilitation (study group) 3. Changes in grip strength measured with a Meden-Inmed Baseline hydraulic hand dynamometer of left and right hand- at baseline and after 3-week rehabilitation (study group)/ 3-week interval (control group)
Overall study start date	19/12/2017
Completion date	30/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	240
Key inclusion criteria	1. Patients with different lung diseases admitted to pulmonary rehabilitation ward 2. Informed consent provided 3. Stable period of illness without infection/exacerbation during the last 4 weeks
Key exclusion criteria	1. Unstable angina 2. Respiratory failure 3. Anemia HgB <10g/dl 4. Bone or central nervous system metastasis 5. Low level of physical activity 6. Severe complications of operative treatment
Date of first enrolment	01/10/2018
Date of final enrolment	01/12/2021

Locations

Countries of recruitment

Poland

Study participating centre

Medical University of Silesia

Department of Lung Diseases and Tuberculosis
Koziolka Steet 1
Zabrze
41-803
Poland

Sponsor information

Medical University of Silesia
University/education

Poniatowskiego Street 15
Katowice
40-055
Poland

Phone	+48 32 2083600
Email	rektor@sum.edu.pl
Website	https://sum.edu.pl/en
"ROR"	https://ror.org/005k7hp45

Funders

Funder type

Government

Narodowe Centrum Nauki (No 2016/23/N/NZ7/02002)

No information available

Results and Publications

Intention to publish date	01/06/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	We intend to publish the first part of the trial, results of FOT in patients with different lung diseases admitted to Pulmonary Rehabilitation Ward in 2020 Secondly, we plan to estimate the usefulness of FOT measurements in rehabilitation in patients with idiopathic interstitial pneumonia in comparison with the control group without rehabilitation program (plan to publish in 2020). And thirdly we plan to assess if FOT may be a more useful measurement method in patients after thoracic surgery subjected to an early rehabilitation (plan to publish in 2022).
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. It will be available online immediately following publication and ending 5 years following article publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		24/06/2022	18/08/2023	Yes	No
Results article		28/10/2022	18/08/2023	Yes	No

Editorial Notes

18/08/2023: Publication references added.
10/07/2020: Trial’s existence confirmed by Bioethics Committee of Medical University of Silesia