Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects

September 5, 2019 updated by: Aslihan CAKMAK, Hacettepe University

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

Completed

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

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06100
        • Aslihan Cakmak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will consist of patients with bronchiectasis and healthy subjects.

Description

Inclusion Criteria:

Inclusion criteria of the Bronchiectasis Group:

  1. Diagnosis of bronchiectasis
  2. Being 18 years of age or older
  3. Able and willing to complete the informed consent process.
  4. Able to walk and co-operate

Exclusion Criteria:

Exclusion criteria of Bronchiectasis Group:

  1. Unstable medical condition
  2. To have severe neurological, orthopedic problems or severe heart failure.

The control group will consist of healthy subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
Seven days
Energy expenditure on activity monitor
Time Frame: Seven days
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
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.

8th day (after using device)
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.
8th day

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)
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
Time Frame: 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.
1st day
Peripheral muscle strength test using a hand-held dynamometer
Time Frame: 8th day (after using device)
Measurement of peripheral muscle strength
8th day (after using device)
Maximal inspiratory and expiratory pressures measurement using a mouthpiece device
Time Frame: 8th day (after using device)
Measurement of respiratory muscle strength
8th day (after using device)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ASLIHAN CAKMAK, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 9, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

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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