Physical Activity in Bronchiectasis

Bronchiectasis Clinical Trial

— PhAB  

Official title:

Patterns of Physical Activity Levels in Patients With Bronchiectasis: Cross Sectional Study Using Quantitative Methodology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569009
• Other study ID #: 11/0085
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: July 24, 2013
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bronchiectasis

Locations

Country	Name	City	State
United Kingdom	Northern Ireland Regional Respiratory Centre (Belfast City Hospital)	Belfast	Co Antrim
United Kingdom	Altnagelvin Area Hospital	Derry	Co Derry
United Kingdom	Craigavon Area Hospital	Portadown	Armagh

Sponsors (6)

Lead Sponsor	Collaborator
University of Ulster	Belfast Health and Social Care Trust, Queen's University, Belfast, Southern Health and Social Care Trust, University of Strathclyde, Western Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of steps on the ActiGraph GT3X+ activity monitor	Participants will wear the ActiGraph GT3X+ activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).	Seven days	No
Secondary	Number of steps on the ActivPAL activity monitor	A sub-group of participants will wear the ActivPAL (n=20). Participants will wear the ActivPAL activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).	Seven days	No
Secondary	Time spent in physical activity and in sitting using the International Physical Activity Questionnaire	Participants will complete the International Physical Activity Questionnaire at Visit 2 (Day 8). It will be used to measure participants' time spent in physical activity in the last seven days and also to provide self-reported sitting time.	Day 8	No
Secondary	Number of steps on the Yamax Digiwalker pedometer	Participants will wear the Yamax Digiwalker pedometer for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).	Seven days	No
Secondary	Exercise Capacity using the Modified Shuttle Test	Participants will complete the Modified Shuttle Test at Visit 2 (Day 8).	Day 8	No
Secondary	Quality of Life using the Quality of Life Questionnaire - Bronchiectasis	Participants will complete the Quality of Life Questionnaire - Bronchiectasis questionnaire at Visit 2 (Day 8).	Day 8	No
Secondary	Quality of Life using the EuroQOL-5D	Participants will complete the EuroQOL-5D at Visit 2 (Day 8).	Day 8	No
Secondary	Quality of Life using the Leicester Cough Questionnaire	Participants will complete the Leicester Cough Questionnaire at Visit 2 (Day 8).	Day 8	No
Secondary	Stage of change in terms of physical activity using the Stages of Change Questionnaire	Participants will complete the Stages of Change Questionnaire at Visit 2 (Day 8). The Stages of Change Questionnaire is the temporal part of the transtheoretical model. It will be used to determine the current stage of change the participant is at in terms of their physical activity behaviour.	Day 8	No
Secondary	Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire	Participants will complete Marcus's Self-Efficacy Questionnaire at Visit 2 (Day 8). Marcus's Self-Efficacy Questionnaire is a component of the transtheoretical model which will provide more detailed information on each individual's confidence to undertake physical activity in different situations.	Day 8	No
Secondary	Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire	Participants will complete Marcus's Decisional Balance Questionnaire at Visit 2 (Day 8). Marcus's Decisional Balance Questionnaire is a component of the transtheoretical model which will assess each individual's perceptions of the benefits and negative aspects of physical activity.	Day 8	No
Secondary	Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire	Participants will complete Marcus's Processes of Change Questionnaire at Visit 2 (Day 8). Marcus's Processes of Change Questionnaire is a component of the transtheoretical model describing the strategies and techniques individuals use to progress through the different stages of change.	Day 8	No
Secondary	Perception of the feasibility and acceptability of the physical activity outcome measures.	The researcher and the participants will answer the feasibility and acceptability questions at Visit 2 (Day 8). The feasibility and acceptibility questions were designed specifically for this study to assess the researchers' and patients' perspectives of the feasibility and acceptability of the physical activity outcome measures.	Day 8	No