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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Melda Sağlam

    Ankara

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04051060
Study groupRoleWhat they receive
Patients with Bronchial AsthmaNot described
Healthy individualsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted9 Aug 2019
  2. Study start1 Feb 2019
  3. Primary completion1 Jan 2020 (estimated)
  4. Study completion1 Jan 2020 (estimated)

Resources

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
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

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.

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