AsthmaNCT04181905
The Relationship Between Kinesiophobia, Physical Activity Level and Quality of Life in Asthma Patients
An observational study of Asthma, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
Asthma is a heterogeneous disease characterized by chronic airway inflammation characterized by time-varying respiratory symptoms such as wheezing, shortness of breath, chest tightness and cough, with limitation of expiratory airflow. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Questionnaire
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Apr 2019to Feb 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The population of the study was the patients diagnosed with asthma. The sample is planned to be composed of 40 people who meet the criteria of reading, read the information form and signed the informed consent form.
Who may be able to join
- Being 18-65 years old T
- Turkish reading, writing, understanding
- Volunteering to participate in the research
Who cannot join
- Having communication problems, not being cooperative, having a psychiatric diagnosis or using medication
- Severe comorbid diseases (heart, respiratory, gastrointestinal, neurological diseases) that may cause movement limitation.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Marmara University
Istanbul, 34000
SEDA KARACA, 00 90 507 ext. 7743857, aisa.sed@gmail.com
- Recruiting
Seda Karaca
Istanbul, 34000
SEDA KARACA, 05077743857, aisa.sed@gmail.com
About this study
Asthma is a heterogeneous disease characterized by chronic airway inflammation characterized by time-varying respiratory symptoms such as wheezing, shortness of breath, chest tightness and cough, with limitation of expiratory airflow. These variations are often triggered by exercise, exposure to allergens or an irritation, weather changes or viral respiratory diseases (Karakış, 2018). Increased respiratory distress decreases the patient's activity, decreases the condition and makes the individual dependent in daily life. In the studies conducted in asthma patients, the cases stated that they perceived their illness as an obstacle against physical activity and thus they were pushed to immobility (Kırtay \& Oğuz, 2011). In the literature, no study on the variable of kinesiophobia in asthma was found. The aim of this study was to investigate the relationship between kinesiophobia and physical activity level and quality of life in asthma patients.
Read the detailed description
Asthma is a chronic inflammatory disease characterized by increased airway sensitivity to various stimuli and reversible airway obstruction (Soyuer et al., 2013). Bronchial hypersensitivity associated with chronic airway inflammation causes wheezing, dyspnea, chest tightness, and cough attacks, especially at midnight or morning. These attacks are associated with varying degrees of airway obstruction and usually improve with treatment or spontaneously (Arslan, 2011). Three mechanisms are responsible for the pathogenesis of asthma. These include reversible airway obstruction, airway inflammation, and increased airway sensitivity (Soyuer et al., 2013). Although it is known that genetic and environmental factors play a role in asthma formation, etiopathogenesis has not been fully explained (Arslan, 2011). Approximately 300 million people worldwide suffer from asthma and this prevalence increases by 50% every ten years. Hospitalization is frequently seen in patients with asthma (Autumn, 2015). It is estimated that approximately 250,000 people die annually due to asthma. No relationship was found between prevalence and mortality (Autumn, 2015). Asthmatic patients have intermittent symptoms such as wheezing, dyspnea, chest tightness, and dry cough. Stimulants such as allergens, air pollution, gastroesophageal reflux, stress and exercise cause these symptoms. 90% of untreated asthmatics develop asthma symptoms during exercise (Dursun et al., 2013). Airway obstruction due to exercise occurs in 40-90% of asthmatics, decreases the ability to exercise and patients prefer a more sedentary lifestyle. Patients with asthma have low physical activity levels because they avoid exercising due to anxiety and depression, inactivity, fatigue, dyspnea (Autumn, 2015). The ability to perform activities and the ability to perform daily living activities are components of quality of life. In many studies, it has been found that quality of life is affected in individuals with chronic lung disease. Quality of life can be assessed with many disease-specific questionnaires. Asthma patients experience problems in many areas in terms of quality of life, including day and night disease symptoms, impaired daily living activities, and reduced quality of life. Asthma is associated with decreased quality of life and morbidity. Asthma symptoms reduce performance at school and at work; affects learning and reduces quality of life. It is stated that asthma has a negative effect on quality of life, physical, physiological and social function (Autumn, 2015).
Airway obstruction due to exercise decreases physical activity in asthmatic patients. This may give rise to fear of movement over time. Avoidance of movement is called kinesiophobia. Kinesiophobia is a condition that occurs when patients want to perform their previous functions, especially in chronic painful disease processes.
Kinesiophobia is an avoidance phenomenon within the cognitive behavioral avoidance model and patients may limit their activity in daily life in case of symptoms of deterioration or the occurrence of symptoms. This may result in emotional problems and life dissatisfaction in later periods (Yumin et al., 2017). Kinesiophobia has been the subject of study in cardiopulmonary cases, but there is no research on kinesiophobia in asthma. In this study, the effect of kinesiophobia on physical activity level and quality of life in asthma will be investigated.
- Conditions
- Asthma
- Being tested
- Questionnaire
- Keywords
- Asthma, Kinesiophobia, Physical Activity, Quality of Life
- Medical subject headings
- Asthma, Kinesiophobia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Firstly, demographic information (name-surname, date of birth, gender, age, height, body weight, dominant hand, family structure, social security, educational status, occupation, smoking, alcohol use, assistive device drug use, resume, surname, complaints). Data collection tools will then be applied to patients by face to face interview technique. Evaluation of kinesiophobia Assessment of quality of life in asthma patients with TAMPA questionnaire Assessment of physical activity level with Asthma Quality of Life Questionnaire (AQLQ) Assessment of physical activity level with International Physical Activity Questionnaire-Short Form (IPAQ) is planned.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Kinesiophobia Scale (TSK)
The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain. The TSK consists of 17 questions.A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
Measured: 7 days
International Physical Activity Questionnaire Short Form (IPAQ-SF)
The International Physical Activity Questionnaire short-form (IPAQ-SF) is one of the most widely used self-report questionnaires to assess PA. IPAQ-SF is a self-report questionnaire that assesses PA in the last 7 days [9-10]. Using the IPAQ-SF scoring system, the total number of days and minutes of PA were calculated for each participant as recommended in the IPAQ website [32]. The IPAQ-SF records the activity in four intensity levels: sitting, walking, moderate intensity (e.g., leisure cycling), and vigorous intensity (e.g, running or aerobics). MET method was used to determine the level of physical activity. Standard values for these activities were established. The generated values are expressed as follows; Severe Physical Activity = 8.0 MET, Moderate Severe Physical Activity = 4.0 MET, Walking = 3.3 MET, Sitting = 1.5 MET. Using these values, daily and weekly physical activity levels are calculated.
Measured: 7 days
Asthma Quality of Life Questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma. Participants were asked to score the importance of each of the positively identified problems (0= not important - 4 = very important). The highest scoring problems were the same for both men and women, for patients with a wide range of asthma severity (no medication to oral steroids) and in different age groups.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start21 Apr 2019
- Primary completion18 Dec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aysel Yildiz Ozer, Study chair, Marmara University, Department of Physiotherapy and RehabilitationSeda Karaca, Principal investigator, Marmara University, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181905
- Sponsor's protocol ID
- 21.02.2019/35
- Status last verified
- Nov 2019
- First submitted
- 27 Nov 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Kinesiophobia, Physical Activity Level and Quality of Life in Asthma Patients
- ClinicalTrials.gov ID
- NCT04181905
- Acronym / sponsor ID
- 21.02.2019/35
- Conditions
- Asthma
- Keywords
- Asthma, Kinesiophobia, Physical Activity, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 21 Apr 2019 (actual)
- Primary completion
- 18 Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 2 Dec 2019 (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.
Asthma is a heterogeneous disease characterized by chronic airway inflammation characterized by time-varying respiratory symptoms such as wheezing, shortness of breath, chest tightness and cough, with limitation of expiratory airflow. These variations are often triggered by exercise, exposure to allergens or an irritation, weather changes or viral respiratory diseases (Karakış, 2018). Increased respiratory distress decreases the patient's activity, decreases the condition and makes the individual dependent in daily life. In the studies conducted in asthma patients, the cases stated that they perceived their illness as an obstacle against physical activity and thus they were pushed to immobility (Kırtay \& Oğuz, 2011). In the literature, no study on the variable of kinesiophobia in asthma was found. The aim of this study was to investigate the relationship between kinesiophobia and physical activity level and quality of life in asthma patients.
Detailed description
Asthma is a chronic inflammatory disease characterized by increased airway sensitivity to various stimuli and reversible airway obstruction (Soyuer et al., 2013). Bronchial hypersensitivity associated with chronic airway inflammation causes wheezing, dyspnea, chest tightness, and cough attacks, especially at midnight or morning. These attacks are associated with varying degrees of airway obstruction and usually improve with treatment or spontaneously (Arslan, 2011). Three mechanisms are responsible for the pathogenesis of asthma. These include reversible airway obstruction, airway inflammation, and increased airway sensitivity (Soyuer et al., 2013). Although it is known that genetic and environmental factors play a role in asthma formation, etiopathogenesis has not been fully explained (Arslan, 2011). Approximately 300 million people worldwide suffer from asthma and this prevalence increases by 50% every ten years. Hospitalization is frequently seen in patients with asthma (Autumn, 2015). It is estimated that approximately 250,000 people die annually due to asthma. No relationship was found between prevalence and mortality (Autumn, 2015). Asthmatic patients have intermittent symptoms such as wheezing, dyspnea, chest tightness, and dry cough. Stimulants such as allergens, air pollution, gastroesophageal reflux, stress and exercise cause these symptoms. 90% of untreated asthmatics develop asthma symptoms during exercise (Dursun et al., 2013). Airway obstruction due to exercise occurs in 40-90% of asthmatics, decreases the ability to exercise and patients prefer a more sedentary lifestyle. Patients with asthma have low physical activity levels because they avoid exercising due to anxiety and depression, inactivity, fatigue, dyspnea (Autumn, 2015). The ability to perform activities and the ability to perform daily living activities are components of quality of life. In many studies, it has been found that quality of life is affected in individuals with chronic lung disease. Quality of life can be assessed with many disease-specific questionnaires. Asthma patients experience problems in many areas in terms of quality of life, including day and night disease symptoms, impaired daily living activities, and reduced quality of life. Asthma is associated with decreased quality of life and morbidity. Asthma symptoms reduce performance at school and at work; affects learning and reduces quality of life. It is stated that asthma has a negative effect on quality of life, physical, physiological and social function (Autumn, 2015).
Airway obstruction due to exercise decreases physical activity in asthmatic patients. This may give rise to fear of movement over time. Avoidance of movement is called kinesiophobia. Kinesiophobia is a condition that occurs when patients want to perform their previous functions, especially in chronic painful disease processes.
Kinesiophobia is an avoidance phenomenon within the cognitive behavioral avoidance model and patients may limit their activity in daily life in case of symptoms of deterioration or the occurrence of symptoms. This may result in emotional problems and life dissatisfaction in later periods (Yumin et al., 2017). Kinesiophobia has been the subject of study in cardiopulmonary cases, but there is no research on kinesiophobia in asthma. In this study, the effect of kinesiophobia on physical activity level and quality of life in asthma will be investigated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study was the patients diagnosed with asthma. The sample is planned to be composed of 40 people who meet the criteria of reading, read the information form and signed the informed consent form.
Key inclusion criteria (3 listed)
- Being 18-65 years old T
- Turkish reading, writing, understanding
- Volunteering to participate in the research
Key exclusion criteria (2 listed)
- Having communication problems, not being cooperative, having a psychiatric diagnosis or using medication
- Severe comorbid diseases (heart, respiratory, gastrointestinal, neurological diseases) that may cause movement limitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireFirstly, demographic information (name-surname, date of birth, gender, age, height, body weight, dominant hand, family structure, social security, educational status, occupation, smoking, alcohol use, assistive device drug use, resume, surname, complaints). Data collection tools will then be applied to patients by face to face interview technique. Evaluation of kinesiophobia Assessment of quality of life in asthma patients with TAMPA questionnaire Assessment of physical activity level with Asthma Quality of Life Questionnaire (AQLQ) Assessment of physical activity level with International Physical Activity Questionnaire-Short Form (IPAQ) is planned. | Other | – |
Primary outcome
Tampa Kinesiophobia Scale (TSK)
Time frame: 7 days
The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain. The TSK consists of 17 questions.A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 7 days
The International Physical Activity Questionnaire short-form (IPAQ-SF) is one of the most widely used self-report questionnaires to assess PA. IPAQ-SF is a self-report questionnaire that assesses PA in the last 7 days [9-10]. Using the IPAQ-SF scoring system, the total number of days and minutes of PA were calculated for each participant as recommended in the IPAQ website [32]. The IPAQ-SF records the activity in four intensity levels: sitting, walking, moderate intensity (e.g., leisure cycling), and vigorous intensity (e.g, running or aerobics). MET method was used to determine the level of physical activity. Standard values for these activities were established. The generated values are expressed as follows; Severe Physical Activity = 8.0 MET, Moderate Severe Physical Activity = 4.0 MET, Walking = 3.3 MET, Sitting = 1.5 MET. Using these values, daily and weekly physical activity levels are calculated.
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: 14 days
The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma. Participants were asked to score the importance of each of the positively identified problems (0= not important - 4 = very important). The highest scoring problems were the same for both men and women, for patients with a wide range of asthma severity (no medication to oral steroids) and in different age groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Aysel Yildiz Ozer study chair
Marmara University, Department of Physiotherapy and Rehabilitation
Seda Karaca principal investigator
Marmara University, Department of Physiotherapy and Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Marmara University at 2 sites 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEDA KARACA (05077743857, aisa.sed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Kinesiophobia Scale (TSK) (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2020.