- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02550821
Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
The purpose of this study is to compare physical activity levels between patients with bronchiectasis and healthy subjects.
We hypothesize that patients with bronchiectasis will have lower levels of physical activity, since physical activity levels is affected by reduced exercise tolerance, severity of disease and other disease related symptoms and conditions.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Physical activity limitation in chronic respiratory diseases is caused by many factors including respiratory, hemodynamic, and peripheral muscle weakness. Bronchiectasis is characterized by irreversible widening of the medium-sized airways, with inflammation, chronic bacterial infection and destruction of the bronchial walls. In addition to pulmonary function worsening, extra pulmonary features such as reduced peripheral muscle endurance can be a significant physical problem which causing a decrease in physical activity levels.
Despite physical activity is considered to be essential for the management of chronic respiratory diseases, there is a lack of scientific study, which compares physical activity levels between patients with bronchiectasis and healthy subjects.
This study will assess physical activity level, exercise capacity, quality of life and peripheral muscle strength in patients with bronchiectasis compared to healthy subjects.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ankara, Kalkun, 06100
- Aslihan Cakmak
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Inclusion criteria of the Bronchiectasis Group:
- Diagnosis of bronchiectasis
- Being 18 years of age or older
- Able and willing to complete the informed consent process.
- Able to walk and co-operate
Exclusion Criteria:
Exclusion criteria of Bronchiectasis Group:
- Unstable medical condition
- To have severe neurological, orthopedic problems or severe heart failure.
The control group will consist of healthy subjects.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of steps on accelerometer
Tidsramme: Seven days
|
Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
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Seven days
|
Energy expenditure on activity monitor
Tidsramme: Seven days
|
Total energy expenditure will be calculated using activity monitor for seven consecutive days
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Seven days
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Exercise capacity using 6-minute walk test and incremental shuttle walk test
Tidsramme: 8th day (after using device)
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6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded. The incremental shuttle walk test will be performed in an enclosed corridor. Patients are required to walk back and forth, turning around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients will follow the rhythm dictated by the audio signal. |
8th day (after using device)
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Physical activity level using International Physical Activity Questionnaire
Tidsramme: 8th day
|
Instrument to obtain internationally comparable data on health related physical activity This measure assesses the types of intensity of physical activity and sitting time in daily life and estimates total physical activity in MET-min/week and time spent sitting.
It comprises open-ended questions surrounding individuals' last 7-day recall of physical activity.
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8th day
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Shortness of breath using the Modified Medical Research Council Dyspnea Scale
Tidsramme: 1st day (before using device)
|
Scale is used to establish functional impairment due to dyspnea attributable to respiratory disease.
The scoring ranges from 0 to 4. The higher scores indicate higher perception of dyspnea.
|
1st day (before using device)
|
Quality of Life using St. George Respiratory Questionnaire
Tidsramme: 1st day
|
It measures the health impairment.
The questionnaire consist of 50 items, 2 parts (3 components).
The name of categories/domains were stated as follows: Part 1: Symptoms component (frequency&severity), Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease).
The scores range from 0 to 100, with higher scores indicating more limitations.
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1st day
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Peripheral muscle strength test using a hand-held dynamometer
Tidsramme: 8th day (after using device)
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Measurement of peripheral muscle strength
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8th day (after using device)
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Maximal inspiratory and expiratory pressures measurement using a mouthpiece device
Tidsramme: 8th day (after using device)
|
Measurement of respiratory muscle strength
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8th day (after using device)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: ASLIHAN CAKMAK, Hacettepe University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GO 15/313
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