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

Completed

• Conditions: Bronchiectasis

• Registration Number: NCT02550821
• Lead Sponsor: Hacettepe University

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.

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-13
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Energy expenditure on activity monitor	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	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.
Number of steps on accelerometer	Seven days	Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
Physical activity level using International Physical Activity Questionnaire	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 Outcome Measures

Name	Time	Method
Quality of Life using St. George Respiratory Questionnaire	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.
Peripheral muscle strength test using a hand-held dynamometer	8th day (after using device)	Measurement of peripheral muscle strength
Shortness of breath using the Modified Medical Research Council Dyspnea Scale	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.
Maximal inspiratory and expiratory pressures measurement using a mouthpiece device	8th day (after using device)	Measurement of respiratory muscle strength

Trial Locations

Locations (1)

Aslihan Cakmak; 🇹🇷 Ankara, Turkey