Evaluation of Exercise Capacity and Activity Role Adequacy in Patients With Adult Bronchial Asthma

Asthma Clinical Trial

— ASTHMA  

Official title:

Evaluation of Exercise Capacity and Activity Role Adequacy in Patients With Adult Bronchial Asthma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04051060
• Other study ID #: GO 19/37
• Status: Enrolling by invitation
• Start date: February 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: August 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study was to evaluate exercise capacity and activity role adequacy in patients with adult bronchial asthma.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Activity Role Qualification
• Asthma
• Fear of Movement

Locations

Country	Name	City	State
Turkey	Melda Saglam	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Primary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	1st Day
Secondary	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.	Day 1