Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
1 other identifier
observational
76
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 13, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 9, 2019
September 1, 2019
11 months
September 13, 2015
September 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of steps on accelerometer
Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
Seven days
Energy expenditure on activity monitor
Total energy expenditure will be calculated using activity monitor for seven consecutive days
Seven days
Exercise capacity using 6-minute walk test and incremental shuttle walk test
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)
Physical activity level using International Physical Activity Questionnaire
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.
8th day
Secondary Outcomes (4)
Shortness of breath using the Modified Medical Research Council Dyspnea Scale
1st day (before using device)
Quality of Life using St. George Respiratory Questionnaire
1st day
Peripheral muscle strength test using a hand-held dynamometer
8th day (after using device)
Maximal inspiratory and expiratory pressures measurement using a mouthpiece device
8th day (after using device)
Eligibility Criteria
The study population will consist of patients with bronchiectasis and healthy subjects.
You may qualify if:
- 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
You may not qualify if:
- Unstable medical condition
- To have severe neurological, orthopedic problems or severe heart failure.
- The control group will consist of healthy subjects.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aslihan Cakmak
Ankara, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ASLIHAN CAKMAK
Hacettepe University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
September 13, 2015
First Posted
September 16, 2015
Study Start
September 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 9, 2019
Record last verified: 2019-09