NCT02550821

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

September 13, 2015

Last Update Submit

September 5, 2019

Conditions

Keywords

Physical activity levelsBronchiectasis

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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)

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • ASLIHAN CAKMAK

    Hacettepe University

    PRINCIPAL INVESTIGATOR

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

Locations