Clinical trial NCT01569009: Physical Activity in Bronchiectasis
Official title: Patterns of Physical Activity Levels in Patients With Bronchiectasis: Cross Sectional Study Using Quantitative Methodology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Physical activity
Activity monitor
Pedometer
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
name: Western Health and Social Care Trust
name: Southern Health and Social Care Trust
name: Queen's University, Belfast
name: University of Strathclyde
First posted: 2012-04-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bronchiecatsis

Brief summary: The primary aim of this study is to examine the physical activity levels of patients with bronchiectasis.

Subsidiary aims are:

1. To examine whether there is a relationship between the physical activity levels of patients with bronchiectasis and clinical phenotype (disease severity, exercise capacity, quality of life or other symptoms of their disease). The investigators also want to explore the relationship between physical activity levels and readiness to change physical activity behaviour (stages of change, self-efficacy, decisional balance and processes of change).
2. To assess the feasibility and acceptability of the physical activity assessment tools: ActiGraph, ActivPAL, pedometer and the International Physical Activity Questionnaire.

Hypothesis:

Patients with bronchiectasis will have low levels of physical activity, and this is related to their clinical phenotype (disease severity, exercise capacity, quality of life and other symptoms of their disease) and also their readiness to change physical activity behaviour (stages of change, self-efficacy, processes of change and decisional balance).

Detailed description: Bronchiectasis is the presence of abnormal, irreversibly dilated, thick walled bronchi that have not been caused by cystic fibrosis. Promoting physical activity and decreasing inactivity (e.g. sedentary periods of activity such as sitting/lying) has been proposed as a key component of care for chronic disease but there is no research on physical activity in bronchiectasis. There is research describing physical activity in other respiratory populations, however, the disease trajectory and demographic profile of bronchiectasis is sufficiently different to warrant the proposed research specifically in bronchiectasis

The investigators need to explore physical activity in bronchiectasis and also provide specific information on the instruments used to measure physical activity. There are several methods which could be used to assess physical activity including subjective methods (e.g. questionnaires), objective methods (e.g. motion sensors). In this study the investigators are using a range of assessment tools to help determine their usefulness (feasibility and acceptability from the health professional and patient perspective) for quantifying physical activity in bronchiectasis.

This study will also assess patients' readiness to change (stages of change, self efficacy, decisional balance and processes of change). Understanding patients with bronchiectasis readiness to change physical activity behaviour and the links between the other important outcome measures will help to inform a future physical activity intervention specifically in patients with bronchiectasis.

Eligibility criteria: Inclusion Criteria:

* aged ≥18 years diagnosis of bronchiectasis confirmed by HRCT or CT
* clinically stable (no exacerbation and no significant change in symptoms or medication in the last four weeks)
* sputum bacteriology completed over the past three months

Exclusion Criteria:

* clinically unstable (pulmonary exacerbation or any change in symptoms or medication in the last four weeks)
* current severe haemoptysis
* pregnancy or any other concomitant condition that would prevent participation

Primary outcomes:
measure: Number of steps on the ActiGraph GT3X+ activity monitor
timeFrame: Seven days
Secondary outcomes:
measure: Number of steps on the ActivPAL activity monitor
timeFrame: Seven days
measure: Time spent in physical activity and in sitting using the International Physical Activity Questionnaire
timeFrame: Day 8
measure: Number of steps on the Yamax Digiwalker pedometer
timeFrame: Seven days
measure: Exercise Capacity using the Modified Shuttle Test
timeFrame: Day 8
measure: Quality of Life using the Quality of Life Questionnaire - Bronchiectasis
timeFrame: Day 8
measure: Quality of Life using the EuroQOL-5D
timeFrame: Day 8
measure: Quality of Life using the Leicester Cough Questionnaire
timeFrame: Day 8
measure: Stage of change in terms of physical activity using the Stages of Change Questionnaire
timeFrame: Day 8
measure: Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
timeFrame: Day 8
measure: Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
timeFrame: Day 8
measure: Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
timeFrame: Day 8
measure: Perception of the feasibility and acceptability of the physical activity outcome measures.
timeFrame: Day 8
Other outcomes:
Locations:
city: Portadown
country: United Kingdom
facility: Craigavon Area Hospital
state: Armagh
city: Belfast
country: United Kingdom
facility: Northern Ireland Regional Respiratory Centre (Belfast City Hospital)
state: Co Antrim
city: Derry
country: United Kingdom
facility: Altnagelvin Area Hospital
state: Co Derry
Study officials:
affiliation: University of Ulster
name: Judy M Bradley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Neill B, McDonough SM, Wilson JJ, Bradbury I, Hayes K, Kirk A, Kent L, Cosgrove D, Bradley JM, Tully MA. Comparing accelerometer, pedometer and a questionnaire for measuring physical activity in bronchiectasis: a validity and feasibility study? Respir Res. 2017 Jan 14;18(1):16. doi: 10.1186/s12931-016-0497-2.
citation: Wilson JJ, Kirk A, Hayes K, Bradbury I, McDonough S, Tully MA, O'Neill B, Bradley JM. Applying the Transtheoretical Model to Physical Activity Behavior in Individuals With Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2016 Jan;61(1):68-77. doi: 10.4187/respcare.04154. Epub 2015 Dec 8.
citation: Bradley JM, Wilson JJ, Hayes K, Kent L, McDonough S, Tully MA, Bradbury I, Kirk A, Cosgrove D, Convery R, Kelly M, Elborn JS, O'Neill B. Sedentary behaviour and physical activity in bronchiectasis: a cross-sectional study. BMC Pulm Med. 2015 May 13;15:61. doi: 10.1186/s12890-015-0046-7.