NCT01569009

Brief Summary

The primary aim of this study is to examine the physical activity levels of patients with bronchiectasis. Subsidiary aims are:

  1. 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. 2.To assess the feasibility and acceptability of the physical activity assessment tools: ActiGraph, ActivPAL, pedometer and the International Physical Activity Questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

March 16, 2012

Last Update Submit

July 24, 2013

Conditions

Bronchiectasis

Keywords

BronchiectasisPhysical activityActivity monitorPedometer

Outcome Measures

Primary Outcomes (1)

  • 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).

    Seven days

Secondary Outcomes (12)

  • Number of steps on the ActivPAL activity monitor

    Seven days

  • Time spent in physical activity and in sitting using the International Physical Activity Questionnaire

    Day 8

  • Number of steps on the Yamax Digiwalker pedometer

    Seven days

  • Exercise Capacity using the Modified Shuttle Test

    Day 8

  • Quality of Life using the Quality of Life Questionnaire - Bronchiectasis

    Day 8

  • +7 more secondary outcomes

Study Arms (1)

Observational

Patients are asked to continue with their normal daily activities.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with bronchiecatsis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Craigavon Area Hospital

Portadown, Armagh, BT63 5QQ, United Kingdom

Location

Northern Ireland Regional Respiratory Centre (Belfast City Hospital)

Belfast, Co Antrim, BT9 7AB, United Kingdom

Location

Altnagelvin Area Hospital

Londonderry, Co Derry, BT47 6SB, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 28088206DERIVED

  • 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.

    PMID: 26647454DERIVED

  • 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.

    PMID: 25967368DERIVED

MeSH Terms

Conditions

BronchiectasisMotor Activity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Judy M Bradley, PhD

    University of Ulster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Physiotherapy

Study Record Dates

First Submitted

March 16, 2012

First Posted

April 2, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

GB(3)