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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550821
• Other study ID #: GO 15/313
• Status: Completed
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 other disease related symptoms and conditions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis

Locations

Country	Name	City	State
Turkey	Aslihan Cakmak	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of steps on accelerometer	Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.	Seven days
Primary	Energy expenditure on activity monitor	Total energy expenditure will be calculated using activity monitor for seven consecutive days	Seven days
Primary	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)
Primary	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	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.	1st day (before using device)
Secondary	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.	1st day
Secondary	Peripheral muscle strength test using a hand-held dynamometer	Measurement of peripheral muscle strength	8th day (after using device)
Secondary	Maximal inspiratory and expiratory pressures measurement using a mouthpiece device	Measurement of respiratory muscle strength	8th day (after using device)