Forced oscillation as lung function test in pulmonary rehabilitation
| ISRCTN | ISRCTN31987937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31987937 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2016/23/N/NZ7/0200 |
| Sponsor | Medical University of Silesia |
| Funder | Narodowe Centrum Nauki (No 2016/23/N/NZ7/02002) |
- 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
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
Scientific
Medical University of Silesia
Koziolka Street 1
Zabrze
41-803
Poland
 ORCID ID |
0000-0002-4844-0609 |
|---|---|
| Phone | +48 662197798 |
| sabina.kostorz@med.sum.edu.pl |
Public
Koziolka Street 1
Zabrze
41-803
Poland
| ORCID ID |
0000-0002-4844-0609 |
|---|---|
| Phone | +48 662197798 |
| kostorz.sabina@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional non-randomized study |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
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) |
| Key secondary outcome measure(s) |
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) |
| Completion date | 30/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Koziolka Steet 1
Zabrze
41-803
Poland
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 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/08/2023: Publication references added.
10/07/2020: Trial’s existence confirmed by Bioethics Committee of Medical University of Silesia
