Assessment of physical capacity of patients diagnosed with bronchial asthma
| ISRCTN | ISRCTN10887245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10887245 |
- Submission date
- 11/07/2023
- Registration date
- 03/08/2023
- Last edited
- 03/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Asthma has a significant impact on the functioning of the patient in society, their physical activity and sports. Typical symptoms of asthma include worsening respiratory symptoms after intense exercise. At the same time, the degree of physical activity is the basic parameter for assessing the degree of disease control. Control of this disease is achieved through appropriate pharmacological treatment and physiotherapeutic activities. The aim of the study is to assess physical capacity in patients diagnosed with bronchial asthma.
Who can participate?
Adult patients aged over 18 years old with bronchial asthma
What does the study involve?
Patients from the research group were qualified for the study on the basis of the results of spirometry tests and bronchial asthma criteria by physicians specializing in allergology and pulmonology. Each subject was informed about the method of conducting the research, the aims of the study and the methods used, and gave written consent.
The protocol of each study includes an interview, instruction on the purpose of the measurements and study procedures. For patients from the research group, the visit protocol consists of a four-part assessment protocol that will look at the subjective feeling of exertion, the severity of dyspnea, quality of life, physical capacity and the degree of physical activity.
The control group patient protocol includes the assessment of the subjective feeling of exertion, the severity of dyspnea, physical capacity and the degree of physical activity.
What are the possible benefits and risks of participating?
Each of the patients who qualify for the study may withdraw from participation at any time. The results of the research will be used to participate in the discussion on the assessment of efficiency, quality of life and the latest forms of therapy used in patients diagnosed with bronchial asthma. There are few risks to participation and for the safety of patients, before and after the six-minute walking test, blood pressure and heart rate, dyspnoea and fatigue will be measured.
Where is the study run from?
Wrocław Medical University (Poland)
When is the study starting and how long is it expected to run for?
November 2018 to February 2019
Who is funding the study?
Wroclaw Medical University (Poland) - SUBZ.E060.23.037
Who is the main contact?
Miss Weronika Bajer, weronika.bajer@umw.edu.pl (Poland)
Contact information
Principal Investigator
Chałubińskiego 3 street
Wroclaw
50-368
Poland
 ORCID ID |
0000-0003-4957-5385 |
|---|---|
| Phone | +48 (0)71 784 28 15 |
| weronika.bajer@umw.edu.pl |
Scientific
Chalubinskiego 3 street
Wroclaw
50-368
Poland
| Phone | +48 (0)71 784 28 15 |
|---|---|
| weronika.bajer@umw.edu.pl |
Public
Chalubinskiego 3 street
Wroclaw
50-368
Poland
| Phone | +48 (0)71 784 28 15 |
|---|---|
| weronika.bajer@umw.edu.pl |
Study information
| Study design | Cross-sectional multicentre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, Other |
| Study type | Other, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Assessment of phySical capacity in patienTs diagnosed with moderate and severe broncHial Asthma (study group) using a 6-minute walk test, the St. George and the International Physical Capacity Questionnaire (IPAQ) - study with a control group |
| Study acronym | ASTHMA |
| Study objectives | The aim of the study is to assess physical capacity and quality of life in patients diagnosed with bronchial asthma and to compare them with patients without cardiopulmonary diseases. |
| Ethics approval(s) |
Approved 25/10/2018, Institutional Review Board at Wroclaw Medical University (ul. J. Mikulicza-Radeckiego 4a, Wrocław, 50-367, Poland; +48 (0)71 784 10 14; bioetyka@umw.edu.pl), ref: KB-568/2018 |
| Health condition(s) or problem(s) studied | Bronchial asthma |
| Intervention | The study will be carried out in two outpatient clinics. Patients diagnosed with bronchial asthma will be examined in the pulmonology clinic and included based on the outcome of spirometric tests carried out by pulmonologists and on the basis of anamnesis, complaints and medical history. Patients without cardiological, pulmonological and orthopedic burdens will be tested as a control group in another clinic. To determine the physical capacity of patients in both groups, a six-minute walk test and measurement of oxygen saturation and blood pressure will be performed. Saturation and blood pressure levels were measured twice, before and after the walk test. To determine the quality of life, the Saint George's Quality of Life Questionnaire will be undertaken for patients with respiratory diseases after prior written consent from the author of the questionnaire. The examination of each patient includes instruction on the purpose of the study and its procedures, consent to participate in the study and the possibility of withdrawing from it, a single diagnostic survey and self-observation. The time of observation, assessment and examination of each patient lasted about 1.5 hours. The results of the research were subjected to statistical analysis. |
| Intervention type | Other |
| Primary outcome measure | 1 Physical capacity measured using the 6-minute walk test (6MWT) at one timepoint 2. Degree of physical activity measured using the International Physical Activity Questionnaire (IPAQ) at one timepoint 3. Quality of life assessments measured using the St. George's Respiratory Questionnaire at one timepoint |
| Secondary outcome measures | Secondary outcome measures are assessed before and after 6MWT: 1. Blood pressure measured using a blood pressure monitor 2. Pulse measured using a pulse oximeter 3. Patient perception of exertion measured using Borg's subjective perception of exertion 4. Dyspnoea measured using the MRC Dyspnoea Scale |
| Overall study start date | 30/09/2018 |
| Completion date | 31/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 63 |
| Key inclusion criteria | 1. Diagnosed with bronchial asthma 2. Current spirometry test performed by a doctor 3. Age >18 years old |
| Key exclusion criteria | 1. Patients with cardiac disease 2. Patients with upper and lower respiratory tract infection in the last 2 weeks 3. Patients with asthma (control group) 3. Patients who do not consent to the research |
| Date of first enrolment | 01/11/2018 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Poland
Study participating centres
Wrocław
54-239
Poland
Saint Catherine
55-010
Poland
Sponsor information
University/education
Wybrzeże L. Pasteura 1
Wroclaw
50-367
Poland
| Phone | +48 (0)71 784 10 11 |
|---|---|
| ewelina.tyczynska@umw.edu.pl | |
| Website | https://www.umw.edu.pl/pl/jednostki/katedra-fizjoterapii |
"ROR" |
https://ror.org/01qpw1b93 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Wroclaw Medical University
- Location
- Poland
Results and Publications
| Intention to publish date | 10/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are available from Miss Weronika Bajer (weronika.bajer@umw.edu.pl) upon request. Raw data (taking into account the anonymity of patients) will become available from the end of the study for 5 years. The research results will be passed on to other researchers in order to compare these results with the results of their own research. |
Editorial Notes
13/07/2023: Trial's existence confirmed by the Institutional Review Board at Wroclaw Medical University (Poland).
