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

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

Study Overview

• Status: Unknown
• Conditions: Asthma; Activity Role Qualification; Fear of Movement

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Melda Sağlam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy individuals
Patients with Bronchial Asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: MELDA SAĞLAM, PhD, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: April 21, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: GO 19/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No