Investigation of Physical Activity Level, Cardiorespiratory Fitness and Quality of Life in Patients With Asthma

Study Overview
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Brief Summary
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The primary aim of the study is to evaluate the physical activity level in patients with asthma. The secondary aims of the study are assesment of maximal and functional exercise capacity, respiratory functions, respiratory muscle strength and endurance, peripheral muscle strength, depression and anxiety levels, disease specific and respiratory quality of life, sleep and coughing associated quality of life, asthma self-management knowledge level and fatigue severity in patients with asthma.

Detailed Description
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Asthma is an obstructive pulmonary disease and thus it affects respiratory functions. Dyspnea, fatigue and bronchial hyperreactivity symptoms are commonly seen on patients with asthma. It is known that physical activity level of asthmatic patients is reduced. Few researches have investigated asthmatic patients' physical activity level and these researches mainly focused on self reported physical activity level. How differing maximal and submaximal exercise capacity of asthmatic patients is not well known. Because previous researches compared only different severity levels of the disease. It is reported that peripheral muscle strength of asthmatic patients is lower than healthy individuals' peripheral muscle strength. But evidences about this subject are insufficient. Asthmatic patients' respiratory muscle strength is lower than healthy individuals' respiratory muscle strength. But it is not clear if endurance is lower as respiratory muscle strength too, or not. It is reported that quality of life of asthmatic patients is worst than healthy individuals'. According to the sample size analysis 36 patients and 36 healthy individuals with similar demographic characteristics will be included the study. Patients and healthy individuals will be selected according to predetermined inclusion and exclusion criteria. The assessments will be completed in two days. Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck Depression Inventory (Turkish version), anxiety using Beck Anxiety Inventory (Turkish version), disease specific quality of life using Asthma Quality of Life Questionnaire (Turkish version) and St. George Respiratory Questionnaire (Turkish version), cough related quality of life using Leicester Cough Questionnaire (Turkish version), sleep related quality of life using Pittsburgh Sleep Quality Index (Turkish version), asthma control level using Asthma Control Test (Turkish version), disease management knowledge level using Asthma Self-Management Questionnaire (Turkish version).

Official Title
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Investigation of Physical Activity Level, Cardiorespiratory Fitness and Quality of Life in Patients With Asthma

Conditions
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Asthma, Physical Activity

Participation Criteria
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Eligibility Criteria
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Inclusion criteria for asthma group: Patients who are; Between 18-65 years Diagnosed with asthma Receiving standard medical treatment Asthma Control Test score ≥ 20 point No smoker or ex-smoker (if ex-smoker, smoke exposure below 10 packyears) Willing to participate in the study Exclusion criteria for asthma group: Patients who are; Have cooperation difficulty Have pulmonary disease (except asthma for asthma group) Have any cardiac, neurological or orthopedic disease that affects functional capacity Have pneumonia or acute infection (at last one month) Have been used oral corticosteroids at last one year Have any psychiatric diseases Refusing to participate Received or are receiving non-standard medical treatment will be excluded from study. Inclusion criteria for healthy group: Participants who are; Between 18-65 years without any diagnosed disease No smoker or ex-smoker (if ex-smoker, smoke exposure below 10 packyears) Willing to participate in the study will be included in healthy group.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma Group<br>That group consists from patients who had diagnosed as asthma by doctors from Chest Diseases Department of Gazi University Hospital. Physical activity level assesment, maximal and submaximal exercise capacity assesment, respiratory function assesment, respiratory muscle strength assesment, respiratory muscle endurance assesment, peripheral muscle strength assesment, quality of life assesment about disease specific, respiratory, sleep and cough associated, fatigue severity assesment, depression and anxiety level assesment and asthma management knowledge assesment apply to this group. | |
| Healthy Group<br>That group consists from participants who do not have any diagnosed disease. Physical activity level assesment, maximal and submaximal exercise capacity assesment, respiratory function assesment, respiratory muscle strength assesment, respiratory muscle endurance assesment, peripheral muscle strength assesment, quality of life assesment about disease specific, respiratory, sleep and cough associated, fatigue severity assesment and depression and anxiety level assesment apply to this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Level | Multi sensor activity monitor | First Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Functions | Spirometry | First Day | 
| Respiratory Muscle Strength | Mouth pressure meter | First Day | 
| Respiratory Muscle Endurance | Incremental threshold loading test | First day | 
| Peripheral Muscle Strength | Hand held dynamometer | First Day | 
| Disease Spesific Quality of Life | Asthma Quality of Life Questionnaire (Turkish version) (disease specific) - Asthma Quality of Life Questionnaire (AQLQ) is a self-reported questionnaire. AQLQ evaluates disease spesific quality of life. This questionnaire includes 32 items and 4 subcategories [Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items)] . Score range for each item from 1 to 7 point (7-point Likert scale). Higher scores show fine quality of life. | First Day | 
| Fatigue Severity | Fatigue Severity Scale (Turkish version) - Fatigue Severity Scale (FSS) is a self-reported questionnaire. FSS evaluates patient's fatigue severity. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue). | First Day | 
| Asthma Self-Management Knowledge | Asthma Self-Management Knowledge Questionnaire (Turkish version) - Asthma Self-Management Knowledge Questionnaire (AKQ) is a self-reported questionnaire. AKQ evaluates patients' knowledge level about disease management. This questionnaire includes 24 items about general asthma knowledge, asthma medications, asthma exacerbations, and environmental triggers, with responses of true or false. This questionnaire scored as counting correct answers. As scoring this questionnaire more correct answer indicates higher knowledge about self-management of disease. | First Day | 
| Functional Exercise Capacity | Six minute stepper test | First Day | 
| Maximal Exercise Capacity | Cardiopulmonary exercise testing (Oxygen consumption measurement during test) | Second Day | 
| Anxiety | Beck Anxiety Inventory (Turkish version) - Beck Anxiety Inventory (BAI) is a self-reported questionnaire. BAI evaluates patients' anxiety level. This questionnaire includes 21 items. Each item scores from 0 to 3 point (higher scores shows more severe anxiety). The BAI scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63). | Second Day | 
| Depression | Beck Depression Inventory (Turkish version) - Beck Depression Inventory (BDI) is a self-reported questionnaire. BDI evaluates patients' depression level. This questionnaire includes 21 items. Each item scores from 0 to 3 point (higher scores shows patient ). The BAI scores are classified as depression over 17 points. | Second day | 
| Respiratory Associated Quality of Life (respiratory) | St. George Respiratory Questionnaire (Turkish version) (respiratory) - St. George Respiratory Questionnaire (SGRQ) is a self-reported questionnaire. SGRQ evaluates patients' respiratory disease associated quality of life. This questionnaire includes 2 part (part one is about symptoms (one subsection) and part two is about activity (seven subsection)) and 50 items. Some items scored as Likert scale and others scored as dichotomous (true/false). | Second day | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Turkish version) - Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire. PSQI evaluates patients' sleep quality. The scale includes 24 questions overall, with 19 questions answered by the person him/ herself and the remaining 5 answered by his/her bed partner or roommate. The first 19 self-answered questions evaluate 7 subscales, subjective sleep quality, sleep latency, duration of sleep, routine sleep activity, sleep disorders, the use of drugs for sleeping, and daytime dysfunction. Each item in the scale is scored between 0 and 3 (no difficulty to severe difficulty). The sum of the 7 subscale scores gives the overall PSQI score. Lower scores show better sleep quality. | Second day | 
| Cough Related Quality of Life | Leicester Cough Questionnaire (Turkish version) - Leicester Cough Questionnaire (LCQ) is a self-reported questionnaire. LCQ evaluates patients' quality of life about cough symptom. This questionnaire includes 19 items and score range for each item from 1 to 7 point (7-point Likert scale). Higher scores show better quality of life about cough symptom. | Second day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Physical activity, Cardiorespiratory fitness, Quality of life