Condition category
Respiratory
Date applied
10/07/2020
Date assigned
23/07/2020
Last edited
23/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://sum.edu.pl/en

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

Publication citations

Additional files

Editorial Notes

10/07/2020: Trial’s existence confirmed by Bioethics Committee of Medical University of Silesia