BronchiectasisPhABNCT01569009
Physical Activity in Bronchiectasis
An observational study of Bronchiectasis, run by University of Ulster at 3 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- How many people
- 63 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jun 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bronchiecatsis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Northern Ireland Regional Respiratory Centre (Belfast City Hospital)
Belfast, Co Antrim, BT9 7AB
Altnagelvin Area Hospital
Londonderry, Co Derry, BT47 6SB
Craigavon Area Hospital
Portadown, Armagh, BT63 5QQ
About this study
Official title: 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:
Read more
- 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).
Read the 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.
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Physical activity, Activity monitor, Pedometer
- Medical subject headings
- Bronchiectasis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients are asked to continue with their normal daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Seven days
Secondary outcomes (12)
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).
Measured: Seven days
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.
Measured: Day 8
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).
Measured: Seven days
Exercise Capacity using the Modified Shuttle Test
Participants will complete the Modified Shuttle Test at Visit 2 (Day 8).
Measured: Day 8
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).
Measured: Day 8
Quality of Life using the EuroQOL-5D
Participants will complete the EuroQOL-5D at Visit 2 (Day 8).
Measured: Day 8
Quality of Life using the Leicester Cough Questionnaire
Participants will complete the Leicester Cough Questionnaire at Visit 2 (Day 8).
Measured: Day 8
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.
Measured: Day 8
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.
Measured: Day 8
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.
Measured: Day 8
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.
Measured: Day 8
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.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Western Health and Social Care Trust, Southern Health and Social Care Trust, Queen's University, Belfast, University of Strathclyde
- Responsible party
- Principal investigator, Judy Bradley, University of Ulster
- Investigators
- Judy M Bradley, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569009
- Sponsor's protocol ID
- 11/0085
- Acronym
- PhAB
- Status last verified
- Jul 2013
- First submitted
- 16 Mar 2012
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28088206Wilson 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.
PubMed 26647454Bradley 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.
PubMed 25967368
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Physical Activity Levels in Patients With Bronchiectasis: Cross Sectional Study Using Quantitative Methodology
- ClinicalTrials.gov ID
- NCT01569009
- Acronym / sponsor ID
- PhAB / 11/0085
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Physical activity, Activity monitor, Pedometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Western Health and Social Care Trust, Southern Health and Social Care Trust, Queen's University, Belfast, University of Strathclyde
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –Patients are asked to continue with their normal daily activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bronchiecatsis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
12 secondary outcomes
Number of steps on the ActivPAL activity monitor
Time frame: Seven days
Time spent in physical activity and in sitting using the International Physical Activity Questionnaire
Time frame: Day 8
Number of steps on the Yamax Digiwalker pedometer
Time frame: Seven days
Exercise Capacity using the Modified Shuttle Test
Time frame: Day 8
Quality of Life using the Quality of Life Questionnaire - Bronchiectasis
Time frame: Day 8
Quality of Life using the EuroQOL-5D
Time frame: Day 8
Quality of Life using the Leicester Cough Questionnaire
Time frame: Day 8
Stage of change in terms of physical activity using the Stages of Change Questionnaire
Time frame: Day 8
Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
Time frame: Day 8
Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
Time frame: Day 8
Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
Time frame: Day 8
Perception of the feasibility and acceptability of the physical activity outcome measures.
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Derived from this study: PubMed 28088206O'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.
- Derived from this study: PubMed 26647454Wilson 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.
- Derived from this study: PubMed 25967368Bradley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy M Bradley, PhD principal investigator
University of Ulster
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by University of Ulster at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps on the ActiGraph GT3X+ activity monitor (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569009, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.