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Completed

NCT Number: NCT01569009

Physical Activity in Bronchiectasis

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).

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Key information

Conditions

Bronchiectasis Behavior Bronchial Diseases Motor Activity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Craigavon Area Hospital, Portadown, Armagh, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. Exercise Capacity using the Modified Shuttle Test

    Time frame: Day 8

    Participants will complete the Modified Shuttle Test at Visit 2 (Day 8).

  5. 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).

  6. Quality of Life using the EuroQOL-5D

    Time frame: Day 8

    Participants will complete the EuroQOL-5D at Visit 2 (Day 8).

  7. Quality of Life using the Leicester Cough Questionnaire

    Time frame: Day 8

    Participants will complete the Leicester Cough Questionnaire at Visit 2 (Day 8).

  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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: PhAB

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2012
Registry last updated
Jul 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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