- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01569009
Physical Activity in Bronchiectasis (PhAB)
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:
- 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).
- 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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Armagh
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Portadown, Armagh, United Kingdom, BT63 5QQ
- Craigavon Area Hospital
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Co Antrim
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Belfast, Co Antrim, United Kingdom, BT9 7AB
- Northern Ireland Regional Respiratory Centre (Belfast City Hospital)
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Co Derry
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Derry, Co Derry, United Kingdom, BT47 6SB
- Altnagelvin Area Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Observational
Patients are asked to continue with their normal daily activities.
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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
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Participants will wear the ActiGraph GT3X+ activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
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Seven days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of steps on the ActivPAL activity monitor
Time Frame: Seven days
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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).
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Seven days
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Time spent in physical activity and in sitting using the International Physical Activity Questionnaire
Time Frame: Day 8
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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.
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Day 8
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Number of steps on the Yamax Digiwalker pedometer
Time Frame: Seven days
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Participants will wear the Yamax Digiwalker pedometer for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
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Seven days
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Exercise Capacity using the Modified Shuttle Test
Time Frame: Day 8
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Participants will complete the Modified Shuttle Test at Visit 2 (Day 8).
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Day 8
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Quality of Life using the Quality of Life Questionnaire - Bronchiectasis
Time Frame: Day 8
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Participants will complete the Quality of Life Questionnaire - Bronchiectasis questionnaire at Visit 2 (Day 8).
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Day 8
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Quality of Life using the EuroQOL-5D
Time Frame: Day 8
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Participants will complete the EuroQOL-5D at Visit 2 (Day 8).
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Day 8
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Quality of Life using the Leicester Cough Questionnaire
Time Frame: Day 8
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Participants will complete the Leicester Cough Questionnaire at Visit 2 (Day 8).
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Day 8
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Stage of change in terms of physical activity using the Stages of Change Questionnaire
Time Frame: Day 8
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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.
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Day 8
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Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
Time Frame: Day 8
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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.
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Day 8
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Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
Time Frame: Day 8
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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.
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Day 8
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Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
Time Frame: Day 8
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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.
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Day 8
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Perception of the feasibility and acceptability of the physical activity outcome measures.
Time Frame: Day 8
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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.
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Day 8
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Judy M Bradley, PhD, University of Ulster
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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