AsthmaASTHMANCT04051060
Evaluation of Exercise Capacity and Activity Role Adequacy in Patients With Adult Bronchial Asthma
An observational study of Asthma and Activity Role Qualification, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate exercise capacity and activity role adequacy in patients with adult bronchial asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Activity Role Qualification, Fear of Movement
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Jan 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who will participate in the study will have stable bronchial asthma who is diagnosed in Kocaeli University Faculty of Medicine, Department of Chest Diseases or has a clinical condition that comes to routine control of Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.
Who may be able to join
- Be diagnosed with bronchial asthma by a chest physician
- Being between the ages of 18-65
- Being in a stable period
- Work in the last 12 months
Who cannot join
- Severe chronic disease other than bronchial asthma (cancer, chronic obstructive pulmonary disease, chronic heart failure, neurological disease, etc.).
- Any physical disability that prevents walking
- Unable to comply with tests
- lack of reading, speaking and writing in Turkish
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to evaluate exercise capacity and activity role adequacy in patients with adult bronchial asthma.
Read the detailed description
Asthma is a chronic inflammatory disease characterized by increased airway sensitivity to various stimuli and reversible airway obstruction. Asthma is a disease with high morbidity and mortality despite all advances in pathogenesis, diagnosis and treatment in the world. It is estimated that there are approximately 300 million asthmatic patients in the world. In our country, approximately one out of every 12-13 adults and one in 7-8 children have asthma. Clinical symptoms of asthma include shortness of breath, wheezing, coughing. Increased symptoms in asthmatic patients lead to impaired respiratory function. In chronic respiratory problems, participants restrict their activity to avoid shortness of breath. As a result, physical fitness levels are reduced, shortness of breath occurs at earlier workloads, and participants do less activity. In chronic disorders, managing the disease alone may not be enough to optimize normal functioning in daily life. In literature, it is seen that daily life activities, quality of life, school performance and work performance are affected in asthmatic patients. it is thought to be useful in determining the course of treatment to be given to the patient in the course of the disease.
- Conditions
- Asthma, Activity Role Qualification, Fear of Movement
- Medical subject headings
- Asthma, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Bronchial Asthma | Not described | |
| Healthy individuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Exercise Capacity
Exercise capacity will be evaluated with a six-minute walk test (6MWT). The patients will be asked to walk as fast as they can in their own walking tempo for six minutes in a 28-meter straight corridor.6DYT distance value has normal values according to age and sex.
These values will be taken as reference in the interpretation of the measurements.
Measured: Day 1
Evaluation of Activity-Role Adequacy
Activity-role adequacy in asthma patients will be assessed using the "Activity Self-Assessment" questionnaire. The Activity Self-Assessment questionnaire is a person-centered assessment tool designed to determine how illness and disability affect individuals' activities and roles. The Activity Self-Assessment Questionnaire is a person-centered assessment questionnaire consisting of 21 items and importance related to activity-role competence. The Activity Self-Assessment questionnaire asks the individual to score each item and value on two separate 4-point scales for activity adequacy. The points obtained are summed up to obtain two separate total points, namely competence and importance. These scores are converted to scores between 0-100 with the method in the application guide of the scale. As the total score increases, activity self-efficacy and importance increases.
Measured: Day 1
Secondary outcomes (7)
Assessment of Respiratory Functions
Pulmonary function test results will be obtained from hospital records. Pulmonary function test parameters will be expressed as a percentage of expected values by age, height, body weight and gender.
Measured: Day 1
Evaluation of Functional Capacity
The functional capacity of the cases will be evaluated by 30-second sit-up test.The full number of starts is recorded for 30 seconds.
Measured: Day 1
Evaluation of Daily Living Activities
Daily living activities of the patients will be evaluated with the London Chest Daily Living Activities Scale. It is a simple and standardized questionnaire developed for the evaluation of dyspnea caused by activities of daily living in patients with obstructive pulmonary diseases (30). This questionnaire consisting of 15 items; personal care (4 items-dry, dress up upper body, wear shoes / socks, wash hair), housework (make 6 item-bed, change bed linen, window / curtain wash, clean / remove dust, wash dishes, sweep), physical activity (2 items-stair climbing, leaning) and leisure (3 items-walking in the house, socially go out, talk) consists of four components. Each item is given a score ranging from 0 to 5. Higher scores indicate that the limitation in GYA is higher. Scale; total score, component score and question score. The total score can reach up to 75.
Measured: Day 1
Evaluation of Quality of Life
Health-related quality of life will be determined by the Nottingham Health Profile (NHP). The NHP consists of 38 items which one can self-complete without the need for an interviewer. The questionnaire has six subscales: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items) and physical mobility (8 items). For each subsection there is a possible range of points ranging from 0-100 points. Higher scores indicate more limitations in quality of life.
Measured: Day 1
Assessment of Quality of Life in Asthmatic Patients
The Asthma Specific Quality of Life Questionnaire (AQLQ) developed by Juniper et al. The questionnaire consists of 32 questions, 11 of which are activity restriction, 12 are symptoms, 5 are mood and 4 are environmental exposure. Patients are asked to remember their experience during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the average response to 32 questions. In this survey, which is grouped under four main headings, firstly the average score is calculated for each title and then the average of these 4 is considered as the overall quality of life score.
Measured: Day 1
Evaluation of fear of motion
Kinesiophobia will be determined using the Tampa Kinesiophobia Scale. The Tampa Kinesiophobia Scale is a checklist of 17 questions. The scale uses a 4-point Likert score (1 = Strongly disagree, 4 = Strongly agree). The person gets a total score between 17-68. The higher the score of the person on the scale, the higher the kinesiophobia.
Measured: 1st Day
Psychosocial Assessment
Psychosocial status of asthmatic patients will be evaluated using Hospital Anxiety and Depression (HAD) Scale. The survey's validity and reliability study in Turkey Aydemir et al. (1997). This scale is used for diagnosing anxiety and depression in a short time and for determining the risk group, not for diagnosing patients with physical illnesses and those applying to primary health care services. The scale consists of a total of 14 items and the items are 4-point Likert type. HAD-A evaluates anxiety with 7 questions and HAD-D evaluates depression with 7 questions. The lowest score that the patients could get from both subscales was 0 and the highest score was 21. The cut-off points of the HADS Scale were 10 for the anxiety subscale (HAD-A) and 7 for the depression subscale.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Feb 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HÜSNA GÜZEL, Hacettepe University
- Investigators
- MELDA SAĞLAM, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051060
- Sponsor's protocol ID
- GO 19/37
- Acronym
- ASTHMA
- Status last verified
- Aug 2019
- First submitted
- 21 Apr 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exercise Capacity and Activity Role Adequacy in Patients With Adult Bronchial Asthma
- ClinicalTrials.gov ID
- NCT04051060
- Acronym / sponsor ID
- ASTHMA / GO 19/37
- Conditions
- Asthma, Activity Role Qualification, Fear of Movement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate exercise capacity and activity role adequacy in patients with adult bronchial asthma.
Detailed description
Asthma is a chronic inflammatory disease characterized by increased airway sensitivity to various stimuli and reversible airway obstruction. Asthma is a disease with high morbidity and mortality despite all advances in pathogenesis, diagnosis and treatment in the world. It is estimated that there are approximately 300 million asthmatic patients in the world. In our country, approximately one out of every 12-13 adults and one in 7-8 children have asthma. Clinical symptoms of asthma include shortness of breath, wheezing, coughing. Increased symptoms in asthmatic patients lead to impaired respiratory function. In chronic respiratory problems, participants restrict their activity to avoid shortness of breath. As a result, physical fitness levels are reduced, shortness of breath occurs at earlier workloads, and participants do less activity. In chronic disorders, managing the disease alone may not be enough to optimize normal functioning in daily life. In literature, it is seen that daily life activities, quality of life, school performance and work performance are affected in asthmatic patients. it is thought to be useful in determining the course of treatment to be given to the patient in the course of the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Bronchial Asthma | – | – |
| Healthy individuals | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who will participate in the study will have stable bronchial asthma who is diagnosed in Kocaeli University Faculty of Medicine, Department of Chest Diseases or has a clinical condition that comes to routine control of Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.
Key inclusion criteria (4 listed)
- Be diagnosed with bronchial asthma by a chest physician
- Being between the ages of 18-65
- Being in a stable period
- Work in the last 12 months
Key exclusion criteria (4 listed)
- Severe chronic disease other than bronchial asthma (cancer, chronic obstructive pulmonary disease, chronic heart failure, neurological disease, etc.).
- Any physical disability that prevents walking
- Unable to comply with tests
- lack of reading, speaking and writing in Turkish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Exercise Capacity
Time frame: Day 1
Exercise capacity will be evaluated with a six-minute walk test (6MWT). The patients will be asked to walk as fast as they can in their own walking tempo for six minutes in a 28-meter straight corridor.6DYT distance value has normal values according to age and sex. These values will be taken as reference in the interpretation of the measurements.
Evaluation of Activity-Role Adequacy
Time frame: Day 1
Activity-role adequacy in asthma patients will be assessed using the "Activity Self-Assessment" questionnaire. The Activity Self-Assessment questionnaire is a person-centered assessment tool designed to determine how illness and disability affect individuals' activities and roles. The Activity Self-Assessment Questionnaire is a person-centered assessment questionnaire consisting of 21 items and importance related to activity-role competence. The Activity Self-Assessment questionnaire asks the individual to score each item and value on two separate 4-point scales for activity adequacy. The points obtained are summed up to obtain two separate total points, namely competence and importance. These scores are converted to scores between 0-100 with the method in the application guide of the scale. As the total score increases, activity self-efficacy and importance increases.
7 secondary outcomes
Assessment of Respiratory Functions
Time frame: Day 1
Evaluation of Functional Capacity
Time frame: Day 1
Evaluation of Daily Living Activities
Time frame: Day 1
Evaluation of Quality of Life
Time frame: Day 1
Assessment of Quality of Life in Asthmatic Patients
Time frame: Day 1
Evaluation of fear of motion
Time frame: 1st Day
Psychosocial Assessment
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MELDA SAĞLAM, PhD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Activity Role Qualification, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Exercise Capacity (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.