BronchiectasisNCT02550821
Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
An observational study of Bronchiectasis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of patients with bronchiectasis and healthy subjects.
Who may be able to join
- 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
Who cannot join
- Unstable medical condition
- To have severe neurological, orthopedic problems or severe heart failure.
- The control group will consist of healthy subjects.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bronchiectasis
- Keywords
- Physical activity levels, Bronchiectasis
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps on accelerometer
Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
Measured: Seven days
Energy expenditure on activity monitor
Total energy expenditure will be calculated using activity monitor for seven consecutive days
Measured: 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.
Measured: 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.
Measured: 8th day
Secondary outcomes (4)
Shortness of breath using the Modified Medical Research Council Dyspnea Scale
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.
Measured: 1st day (before using device)
Quality of Life using St. George Respiratory Questionnaire
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.
Measured: 1st day
Peripheral muscle strength test using a hand-held dynamometer
Measurement of peripheral muscle strength
Measured: 8th day (after using device)
Maximal inspiratory and expiratory pressures measurement using a mouthpiece device
Measurement of respiratory muscle strength
Measured: 8th day (after using device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan CAKMAK, Hacettepe University
- Investigators
- ASLIHAN CAKMAK, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550821
- Sponsor's protocol ID
- GO 15/313
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2015
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02550821
- Acronym / sponsor ID
- GO 15/313
- Conditions
- Bronchiectasis
- Keywords
- Physical activity levels, Bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with bronchiectasis and healthy subjects.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unstable medical condition
- To have severe neurological, orthopedic problems or severe heart failure.
- The control group will consist of healthy subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of steps on accelerometer
Time frame: Seven days
Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
Energy expenditure on activity monitor
Time frame: Seven days
Total energy expenditure will be calculated using activity monitor for seven consecutive days
Exercise capacity using 6-minute walk test and incremental shuttle walk test
Time frame: 8th day (after using device)
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.
Physical activity level using International Physical Activity Questionnaire
Time frame: 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.
4 secondary outcomes
Shortness of breath using the Modified Medical Research Council Dyspnea Scale
Time frame: 1st day (before using device)
Quality of Life using St. George Respiratory Questionnaire
Time frame: 1st day
Peripheral muscle strength test using a hand-held dynamometer
Time frame: 8th day (after using device)
Maximal inspiratory and expiratory pressures measurement using a mouthpiece device
Time frame: 8th day (after using device)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ASLIHAN CAKMAK principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps on accelerometer (time frame: Seven days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.