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Physical Activity in Bronchiectasis (PhAB)

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ClinicalTrials.gov Identifier: NCT01569009
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : July 25, 2013
Sponsor:
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
Information provided by (Responsible Party):
Judy Bradley, University of Ulster

Tracking Information
First Submitted Date March 16, 2012
First Posted Date April 2, 2012
Last Update Posted Date July 25, 2013
Study Start Date June 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2012)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 29, 2012)
  • 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).
  • 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.
  • 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).
  • Exercise Capacity using the Modified Shuttle Test [ Time Frame: Day 8 ]
    Participants will complete the Modified Shuttle Test at Visit 2 (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).
  • Quality of Life using the EuroQOL-5D [ Time Frame: Day 8 ]
    Participants will complete the EuroQOL-5D at Visit 2 (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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Physical Activity in Bronchiectasis
Official Title Patterns of Physical Activity Levels in Patients With Bronchiectasis: Cross Sectional Study Using Quantitative Methodology
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with bronchiecatsis
Condition Bronchiectasis
Intervention Not Provided
Study Groups/Cohorts Observational
Patients are asked to continue with their normal daily activities.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2012)
63
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01569009
Other Study ID Numbers 11/0085
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Judy Bradley, University of Ulster
Study Sponsor University of Ulster
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
Investigators
Principal Investigator: Judy M Bradley, PhD University of Ulster
PRS Account University of Ulster
Verification Date July 2013