Clinical trial NCT03509311: Investigation of Physical Activity Level, Cardiorespiratory Fitness and Quality of Life in Patients With Asthma
Official title: Investigation of Physical Activity Level, Cardiorespiratory Fitness and Quality of Life in Patients With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Physical Activity
Keywords: Asthma
Physical activity
Cardiorespiratory fitness
Quality of life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For Asthma Group:

Thirty six patients with asthma will be included in this group

For Healthy Group:

Thirty six healthy volunteer will be included in this group.

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity Level
timeFrame: First Day
Secondary outcomes:
measure: Pulmonary Functions
timeFrame: First Day
measure: Respiratory Muscle Strength
timeFrame: First Day
measure: Respiratory Muscle Endurance
timeFrame: First day
measure: Peripheral Muscle Strength
timeFrame: First Day
measure: Disease Spesific Quality of Life
timeFrame: First Day
measure: Fatigue Severity
timeFrame: First Day
measure: Asthma Self-Management Knowledge
timeFrame: First Day
measure: Functional Exercise Capacity
timeFrame: First Day
measure: Maximal Exercise Capacity
timeFrame: Second Day
measure: Anxiety
timeFrame: Second Day
measure: Depression
timeFrame: Second day
measure: Respiratory Associated Quality of Life (respiratory)
timeFrame: Second day
measure: Sleep Quality
timeFrame: Second day
measure: Cough Related Quality of Life
timeFrame: Second day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Study officials:
affiliation: Gazi University
name: Furkan Ozdemir, PT
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Bosnak Guclu, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Hanim Eda Goktas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: I. Kivilcim Oguzulgen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1080/00913847.2016.1176546. Epub 2016 Apr 26.
citation: Ramos E, de Oliveira LV, Silva AB, Costa IP, Correa 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.
citation: Vargas Becerra MH. [Physiopathology of asthma]. Rev Alerg Mex. 2009;56 Suppl 1:S24-8. Spanish.
citation: Fitting JW. [Fatigue of the respiratory muscles]. Schweiz Med Wochenschr. 1992 Feb 29;122(9):302-6. French.
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. doi: 10.1053/rmed.2000.0968.
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.