- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06100
- Aslihan Cakmak
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of steps on accelerometer
Time Frame: Seven days
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Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
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Seven days
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Energy expenditure on activity monitor
Time Frame: Seven days
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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
Time Frame: 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
Time Frame: 8th day
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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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shortness of breath using the Modified Medical Research Council Dyspnea Scale
Time Frame: 1st day (before using device)
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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.
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1st day (before using device)
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Quality of Life using St. George Respiratory Questionnaire
Time Frame: 1st day
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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
Time Frame: 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
Time Frame: 8th day (after using device)
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Measurement of respiratory muscle strength
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8th day (after using device)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ASLIHAN CAKMAK, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 15/313
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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