Clinical trial NCT04006015: Activity, Balance and COPD (ABCOPD)
Official title: Activity, Balance and COPD: An Exploratory Study of Physical Activity and Balance in Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Keywords: COPD
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with stable chronic lung disease.

Brief summary: This research project incorporates a series of studies to investigate the relationship between physical performance (e.g. tests of strength, balance and walking distance) and physical activity (activity measured in day to day life) in people with COPD and other chronic lung diseases.

Detailed description: The research project incorporates the following components:

Study 1) A prospective, observational study, to assess the relationship between a comprehensive set of measures of walking ability, strength and balance, and daily physical activity in people with chronic lung disease. Patients will attend a single assessment session to evaluate physical capacity. They will also wear a physical activity monitor for a week following completing these tests to assess physical activity and aspects of physical performance. Participants will also be invited to return two months later to provide evidence about the repeatability of measurements.

Study 2) A parallel study comparing assessment of performance during six-minute walk tests by an observer to a semi-automated assessment using an activity monitor worn by the patient. This will involve a single visit and be carried out during walking tests carried out as part of routine clinical care.

Study 3) A qualitative study to investigate experiences and perceptions of participants of dance groups for people with chronic lung disease, as a novel form of physical activity. This will be used to inform the design of subsequent trials of dance interventions for chronic lung disease.

Eligibility criteria: Inclusion Criteria:

* Adults with stable chronic lung disease
* Able to understand instructions.
* Age and sex matched healthy controls.

Exclusion Criteria:

* For the main study, the presence of other comorbidities causing a significant reduction in mobility (for example stroke with neurological deficits, severe arthritis, significant peripheral neuropathy, significant visual impairment, dementia etc.).
* exacerbation of lung disease within the last 2 months.

Primary outcomes:
measure: Free-living gait stability as assessed by activity monitor
timeFrame: 7 days.
Secondary outcomes:
measure: Physical activity assessed by step count using activity monitor
timeFrame: 7 days.
measure: Clinical balance assessment
timeFrame: Assessed during single clinical assessement at baseline.
measure: Physical performance assessment
timeFrame: Assessed during single clinical assessment at baseline.
measure: Balance confidence
timeFrame: Assessed during a single clinical assessment at baseline.
measure: Walking distance in metres
timeFrame: Assessed during a single clinical assessment at baseline.
measure: Patient experience as assessed by semi-structured interviews
timeFrame: 1 hour.
measure: Physical Activity: Movement intensity (in average body acceleration (g) during activity)
timeFrame: 7 days.
measure: Physical activity: types of activity (time in minutes spent standing, walking, lying, sitting, cycling, running) assessed with activity monitor.
timeFrame: 7 days.
measure: Timed Up and Go (TUG)
timeFrame: Assessed during a single clinical assessment at baseline.
measure: Functional reach test
timeFrame: Assessed during a single clinical assessment at baseline.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Heart and Lung Institute, Imperial College London
Study officials:
affiliation: Imperial College London
name: Nicholas Hopkinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Philip KEJ, Lewis A, Williams S, Buttery SC, Polkey MI, Man W, Fancourt D, Hopkinson NS. Dance for people with chronic respiratory disease: a qualitative study. BMJ Open. 2020 Oct 13;10(10):e038719. doi: 10.1136/bmjopen-2020-038719.