NCT04080583

Brief Summary

Short Actives Lives Survey is a common tool used to measure physical activity in the UK population. Self-reported measures such as the Short Active Lives Survey can be prone to bias. As such, during project evaluations, benefits may be exaggerated due to over-reporting of physical activity or downplayed due to underreporting of physical activity. There is also a lack of research reporting the typical short-term and long-term changes in physical activity (measured by the Short Active Lives Survey) in people with chronic lung conditions who are not receiving support to become active (i.e. usual care, control groups). Accelerometers are small lightweight activity monitors that can be worn on the waist. These monitors are known to provide accurate and reliable objective assessment of physical activity in people with lung conditions. This research study will recruit a cohort of inactive people with lung conditions and determine changes in physical activity measured by both the Short Active Lives Survey and one of the most valid accelerometers used in people with lung conditions (Actigraph GT3X). The study will also evaluate how these physical activity measures relate to general health (health status and health care use) of people with lung conditions over 12 months. This study will provide information on the usefulness of using the Short Active Lives Survey in the future for measuring physical activity in people with lung conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 27, 2021

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

September 3, 2019

Last Update Submit

April 26, 2021

Conditions

Keywords

Physical activityHealth Status

Outcome Measures

Primary Outcomes (1)

  • Minutes of self-reported moderate intensity equivalent physical activity per week

    Short Active Lives Survey

    Baseline to 12 months

Secondary Outcomes (10)

  • Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity

    Baseline to 12 months

  • Accelerometer measured physical activity: time (minutes per week) spent in light activity

    Baseline to 12 months

  • Accelerometer measured physical activity including: time (minutes per week) spent in vigorous activity

    Baseline to 12 months

  • Accelerometer measured physical activity: time (minutes per day) spent in sedentary state

    Baseline to 12 months

  • Accelerometer measured physical activity: average daily steps

    Baseline to 12 months

  • +5 more secondary outcomes

Study Arms (1)

Usual Care

People with a chronic lung condition who are physically inactive

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The eligibility criteria has been designed to be as broad as possible so that findings can be generalisable to the wider population of inactive people with lung conditions. The main study population will be recruited via convenience sampling at the participant identification centres within Lincolnshire Community Health Services, South Lincolnshire CCG, South West Lincolnshire CCG, Lincolnshire East CCG, Lincolnshire West CCG and United Lincolnshire Hospitals NHS Trust.

You may qualify if:

  • Diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
  • Physically inactive defined as completing less than 30 minutes ore more of moderate intensity equivalent physical activity per week (measured by the Short Active Lives Survey)

You may not qualify if:

  • Adults without a diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
  • Age \< 18 Years
  • Completing 30 minutes or more of moderate intensity equivalent (MIE) physical activity per week
  • Inability or unwillingness to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lincoln

Lincoln, Lincolnshire, LN6 7TS, United Kingdom

Location

MeSH Terms

Conditions

Lung DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBehavior

Study Officials

  • Arwel W Jones, PhD

    University of Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

August 1, 2019

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

April 27, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations