Asthma Clinical Trial
Official title:
Investigation of Physical Activity Level, Cardiorespiratory Fitness and Quality of Life in Patients With Asthma
Verified date | May 2021 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|