AsthmaNCT03509311
Investigation of Physical Activity Level, Cardiorespiratory Fitness and Quality of Life in Patients With Asthma
An observational study of Asthma and Physical Activity, run by Gazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Physical Activity
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2018to 30 Jul 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Ankara, 06560
About this study
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.
Read the 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).
- Conditions
- Asthma, Physical Activity
- Keywords
- Asthma, Physical activity, Cardiorespiratory fitness, Quality of life
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Group | 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 | 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 being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
Multi sensor activity monitor
Measured: First Day
Secondary outcomes (14)
Pulmonary Functions
Spirometry
Measured: First Day
Respiratory Muscle Strength
Mouth pressure meter
Measured: First Day
Respiratory Muscle Endurance
Incremental threshold loading test
Measured: First day
Peripheral Muscle Strength
Hand held dynamometer
Measured: 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.
Measured: 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).
Measured: 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.
Measured: First Day
Functional Exercise Capacity
Six minute stepper test
Measured: First Day
Maximal Exercise Capacity
Cardiopulmonary exercise testing (Oxygen consumption measurement during test)
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start20 Apr 2018
- Primary completion30 Jan 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Furkan Ozdemir, PT, Study chair, Gazi UniversityMeral Bosnak Guclu, Assoc. Prof, Study director, Gazi UniversityHanim Eda Goktas, PhD, Principal investigator, Gazi UniversityI. Kivilcim Oguzulgen, MD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509311
- Sponsor's protocol ID
- Gazi University 11
- Status last verified
- May 2021
- First submitted
- 17 Apr 2018
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27495092Shei 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.
PubMed 27094568Ramos 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.
PubMed 25973197Vargas Becerra MH. [Physiopathology of asthma]. Rev Alerg Mex. 2009;56 Suppl 1:S24-8. Spanish.
PubMed 20873050Fitting JW. [Fatigue of the respiratory muscles]. Schweiz Med Wochenschr. 1992 Feb 29;122(9):302-6. French.
PubMed 1546280Cluley 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.
PubMed 11207015Stucky 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.
PubMed 25882804
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Physical Activity Level, Cardiorespiratory Fitness and Quality of Life in Patients With Asthma
- ClinicalTrials.gov ID
- NCT03509311
- Acronym / sponsor ID
- Gazi University 11
- Conditions
- Asthma, Physical Activity
- Keywords
- Asthma, Physical activity, Cardiorespiratory fitness, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Group | – | –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 | – | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical Activity Level
Time frame: First Day
Multi sensor activity monitor
14 secondary outcomes
Pulmonary Functions
Time frame: First Day
Respiratory Muscle Strength
Time frame: First Day
Respiratory Muscle Endurance
Time frame: First day
Peripheral Muscle Strength
Time frame: First Day
Disease Spesific Quality of Life
Time frame: First Day
Fatigue Severity
Time frame: First Day
Asthma Self-Management Knowledge
Time frame: First Day
Functional Exercise Capacity
Time frame: First Day
Maximal Exercise Capacity
Time frame: Second Day
Anxiety
Time frame: Second Day
Depression
Time frame: Second day
Respiratory Associated Quality of Life (respiratory)
Time frame: Second day
Sleep Quality
Time frame: Second day
Cough Related Quality of Life
Time frame: Second day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 27495092Bruno 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.
- Background: PubMed 27094568Shei 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.
- Background: PubMed 25973197Ramos 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.
- Background: PubMed 20873050Vargas Becerra MH. [Physiopathology of asthma]. Rev Alerg Mex. 2009;56 Suppl 1:S24-8. Spanish.
- Background: PubMed 1546280Fitting JW. [Fatigue of the respiratory muscles]. Schweiz Med Wochenschr. 1992 Feb 29;122(9):302-6. French.
- Background: PubMed 11207015Cluley 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.
- Background: PubMed 25882804Stucky 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Furkan Ozdemir, PT study chair
Gazi University
Meral Bosnak Guclu, Assoc. Prof study director
Gazi University
Hanim Eda Goktas, PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Physical Activity, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: First Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509311, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.