Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Sabina Kostorz-Nosal
ORCID ID
http://orcid.org/0000-0002-4844-0609
Contact details
Medical University of Silesia
Koziolka Street 1
Zabrze
41-803
Poland
+48 662197798
sabina.kostorz@med.sum.edu.pl
Type
Public
Additional contact
Mrs Sabina Kostorz-Nosal
ORCID ID
http://orcid.org/0000-0002-4844-0609
Contact details
Koziolka Street 1
Zabrze
41-803
Poland
+48 662197798
kostorz.sabina@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2016/23/N/NZ7/0200
Study information
Scientific title
The forced oscillation technique in patients with lung diseases subjected to pulmonary rehabilitation.
Acronym
Study hypothesis
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
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
Study design
Single-centre interventional non-randomized study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
19/12/2017
Overall trial end date
30/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant 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
Recruitment start date
01/10/2018
Recruitment end date
01/12/2021
Locations
Countries of recruitment
Poland
Trial participating centre
Medical University of Silesia
Department of Lung Diseases and Tuberculosis
Koziolka Steet 1
Zabrze
41-803
Poland
Sponsor information
Organisation
Medical University of Silesia
Sponsor details
Poniatowskiego Street 15
Katowice
40-055
Poland
+48 32 2083600
rektor@sum.edu.pl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Narodowe Centrum Nauki (No 2016/23/N/NZ7/02002)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement:
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.
Intention to publish date
01/06/2022
Participant level data
Available on request
Basic results (scientific)
Publication list