Physical Activity in Bronchiectasis (PhAB)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01569009
First received: March 16, 2012
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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).


Condition
Bronchiectasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Patterns of Physical Activity Levels in Patients With Bronchiectasis: Cross Sectional Study Using Quantitative Methodology

Further study details as provided by University of Ulster:

Primary Outcome Measures:
  • Number of steps on the ActiGraph GT3X+ activity monitor [ Time Frame: Seven days ] [ Designated as safety issue: No ]
    Participants will wear the ActiGraph GT3X+ activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).


Secondary Outcome Measures:
  • Number of steps on the ActivPAL activity monitor [ Time Frame: Seven days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants will complete the EuroQOL-5D at Visit 2 (Day 8).

  • Quality of Life using the Leicester Cough Questionnaire [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 63
Study Start Date: June 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational
Patients are asked to continue with their normal daily activities.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with bronchiecatsis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569009

Locations
United Kingdom
Craigavon Area Hospital
Portadown, Armagh, United Kingdom, BT63 5QQ
Northern Ireland Regional Respiratory Centre (Belfast City Hospital)
Belfast, Co Antrim, United Kingdom, BT9 7AB
Altnagelvin Area Hospital
Derry, Co Derry, United Kingdom, BT47 6SB
Sponsors and Collaborators
University of Ulster
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
  More Information

No publications provided

Responsible Party: Judy Bradley, Reader in Physiotherapy, University of Ulster
ClinicalTrials.gov Identifier: NCT01569009     History of Changes
Other Study ID Numbers: 11/0085
Study First Received: March 16, 2012
Last Updated: July 24, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Ulster:
Bronchiectasis
Physical activity
Activity monitor
Pedometer

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014