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

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ClinicalTrials.gov Identifier: NCT03509311
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Meral Boşnak Güçlü, Gazi University

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.

Condition or disease
Asthma Physical Activity

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 72 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Investigation of Physical Activity Level, Cardiorespiratory Fitness and Quality of Life in Patients With Asthma
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Physical Activity Level [ Time Frame: First Day ]
    Multi sensor activity monitor


Secondary Outcome Measures :
  1. Pulmonary Functions [ Time Frame: First Day ]
    Spirometry

  2. Respiratory Muscle Strength [ Time Frame: First Day ]
    Mouth pressure meter

  3. Respiratory Muscle Endurance [ Time Frame: First day ]
    Incremental threshold loading test

  4. Peripheral Muscle Strength [ Time Frame: First Day ]
    Hand held dynamometer

  5. Disease Spesific Quality of Life [ Time Frame: First Day ]
    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.

  6. Fatigue Severity [ Time Frame: First Day ]
    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).

  7. Asthma Self-Management Knowledge [ Time Frame: First Day ]
    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.

  8. Functional Exercise Capacity [ Time Frame: First Day ]
    Six minute stepper test

  9. Maximal Exercise Capacity [ Time Frame: Second Day ]
    Cardiopulmonary exercise testing (Oxygen consumption measurement during test)

  10. Anxiety [ Time Frame: Second Day ]
    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).

  11. Depression [ Time Frame: Second day ]
    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.

  12. Respiratory Associated Quality of Life (respiratory) [ Time Frame: Second day ]
    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).

  13. Sleep Quality [ Time Frame: Second day ]
    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.

  14. Cough Related Quality of Life [ Time Frame: Second day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509311


Contacts
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Contact: Meral Bosnak Guclu, Assoc. Prof. +90-312-2162929 bosnakmeral@hotmail.com
Contact: Furkan Ozdemir, PT +90-538-326-48 55 furkan.ozdemir.ank@gmail.com

Locations
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Turkey
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic Recruiting
Ankara, Turkey, 06560
Contact: Meral Bosnak Guclu, PhD    +90-3122162929    bosnakmeral@hotmail.com   
Contact: Furkan Ozdemir, PT    +90-538-326-48 55    furkan.ozdemir.ank@gmail.com   
Sponsors and Collaborators
Gazi University
Investigators
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Study Chair: Furkan Ozdemir, PT Gazi University
Study Director: Meral Bosnak Guclu, Assoc. Prof Gazi University
Principal Investigator: Hanim Eda Goktas, PhD Gazi University
Principal Investigator: I. Kivilcim Oguzulgen, MD Gazi University

Additional Information:

Publications:
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Responsible Party: Meral Boşnak Güçlü, Assoc. Prof., Gazi University
ClinicalTrials.gov Identifier: NCT03509311     History of Changes
Other Study ID Numbers: Gazi University 11
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meral Boşnak Güçlü, Gazi University:
Asthma
Physical activity
Cardiorespiratory fitness
Quality of life
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases