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Completed

NCT Number: 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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aslihan Cakmak

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of steps on accelerometer

    Time frame: Seven days

    Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.

  2. Energy expenditure on activity monitor

    Time frame: Seven days

    Total energy expenditure will be calculated using activity monitor for seven consecutive days

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Peripheral muscle strength test using a hand-held dynamometer

    Time frame: 8th day (after using device)

    Measurement of peripheral muscle strength

  4. Maximal inspiratory and expiratory pressures measurement using a mouthpiece device

    Time frame: 8th day (after using device)

    Measurement of respiratory muscle strength

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2015
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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