Physical Activity in Bronchiectasis (PhAB)

July 24, 2013 updated by: Judy Bradley, University of Ulster

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

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Armagh
      • Portadown, Armagh, United Kingdom, BT63 5QQ
        • Craigavon Area Hospital
    • Co Antrim
      • Belfast, Co Antrim, United Kingdom, BT9 7AB
        • Northern Ireland Regional Respiratory Centre (Belfast City Hospital)
    • Co Derry
      • Derry, Co Derry, United Kingdom, BT47 6SB
        • Altnagelvin Area Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with bronchiecatsis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Observational
Patients are asked to continue with their normal daily activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of steps on the ActiGraph GT3X+ activity monitor
Time Frame: Seven days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of steps on the ActivPAL activity monitor
Time Frame: Seven days
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
Time spent in physical activity and in sitting using the International Physical Activity Questionnaire
Time Frame: Day 8
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
Number of steps on the Yamax Digiwalker pedometer
Time Frame: Seven days
Participants will wear the Yamax Digiwalker pedometer for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
Seven days
Exercise Capacity using the Modified Shuttle Test
Time Frame: Day 8
Participants will complete the Modified Shuttle Test at Visit 2 (Day 8).
Day 8
Quality of Life using the Quality of Life Questionnaire - Bronchiectasis
Time Frame: Day 8
Participants will complete the Quality of Life Questionnaire - Bronchiectasis questionnaire at Visit 2 (Day 8).
Day 8
Quality of Life using the EuroQOL-5D
Time Frame: Day 8
Participants will complete the EuroQOL-5D at Visit 2 (Day 8).
Day 8
Quality of Life using the Leicester Cough Questionnaire
Time Frame: Day 8
Participants will complete the Leicester Cough Questionnaire at Visit 2 (Day 8).
Day 8
Stage of change in terms of physical activity using the Stages of Change Questionnaire
Time Frame: Day 8
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
Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
Time Frame: Day 8
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
Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
Time Frame: Day 8
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
Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
Time Frame: Day 8
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
Perception of the feasibility and acceptability of the physical activity outcome measures.
Time Frame: Day 8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

July 25, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 11/0085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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