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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509311
• Other study ID #: Gazi University 11
• Status: Completed
• Start date: April 20, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: May 2021
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Physical Activity

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Bruno A, Uasuf CG, Insalaco G, Barazzoni R, Ballacchino A, Gjomarkaj M, Pace E. Nutritional status and physical inactivity in moderated asthmatics: A pilot study. Medicine (Baltimore). 2016 Aug;95(31):e4485. doi: 10.1097/MD.0000000000004485. — View Citation

Cluley S, Cochrane GM. Psychological disorder in asthma is associated with poor control and poor adherence to inhaled steroids. Respir Med. 2001 Jan;95(1):37-9. — View Citation

Fitting JW. [Fatigue of the respiratory muscles]. Schweiz Med Wochenschr. 1992 Feb 29;122(9):302-6. Review. French. — View Citation

Ramos E, de Oliveira LV, Silva AB, Costa IP, Corrêa JC, Costa D, Alves VL, Donner CF, Stirbulov R, Arena R, Sampaio LM. Peripheral muscle strength and functional capacity in patients with moderate to severe asthma. Multidiscip Respir Med. 2015 Jan 21;10(1):3. doi: 10.1186/2049-6958-10-3. eCollection 2015. — View Citation

Shei RJ, Paris HL, Wilhite DP, Chapman RF, Mickleborough TD. The role of inspiratory muscle training in the management of asthma and exercise-induced bronchoconstriction. Phys Sportsmed. 2016 Nov;44(4):327-334. Epub 2016 Apr 26. Review. — View Citation

Stucky BD, Sherbourne CD, Edelen MO, Eberhart NK. Understanding asthma-specific quality of life: moving beyond asthma symptoms and severity. Eur Respir J. 2015 Sep;46(3):680-7. doi: 10.1183/09031936.00225014. Epub 2015 Apr 16. — View Citation

Vargas Becerra MH. [Physiopathology of asthma]. Rev Alerg Mex. 2009;56 Suppl 1:S24-8. Review. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Level	Multi sensor activity monitor	First Day
Secondary	Pulmonary Functions	Spirometry	First Day
Secondary	Respiratory Muscle Strength	Mouth pressure meter	First Day
Secondary	Respiratory Muscle Endurance	Incremental threshold loading test	First day
Secondary	Peripheral Muscle Strength	Hand held dynamometer	First Day
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional Exercise Capacity	Six minute stepper test	First Day
Secondary	Maximal Exercise Capacity	Cardiopulmonary exercise testing (Oxygen consumption measurement during test)	Second Day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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