Activity, Balance and COPD (ABCOPD)

COPD Clinical Trial

— ABCOPD  

Official title:

Activity, Balance and COPD: An Exploratory Study of Physical Activity and Balance in Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04006015
• Other study ID #: IRAS Project ID: 258399
• Status: Recruiting
• Start date: June 24, 2019
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: Imperial College London
• Contact: Keir EJ Philip, MRCP
• Phone: 0044(0)2073528121
• Email: k.philip[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• No intervention being delivered.
No interventions are being delivered.

Locations

Country	Name	City	State
United Kingdom	National Heart and Lung Institute, Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free-living gait stability as assessed by activity monitor	The free-living gait stability parameters derived from the fixed body sensor worn during activity monitoring at home.	7 days.
Secondary	Physical activity assessed by step count using activity monitor	Physical activity assessed using step count (number of steps), as assessed using the activity monitor at home (McRoberts MoveMonitor).	7 days.
Secondary	Clinical balance assessment	Assessed using the miniBESTest in clinical setting.	Assessed during single clinical assessement at baseline.
Secondary	Physical performance assessment	Assessed using the Short Physical Performance Battery (SPPB) in clinical setting.	Assessed during single clinical assessment at baseline.
Secondary	Balance confidence	Assessed using the Activities-specific Balance Confidence (ABC) scale. This is a self completed measure of balance confidence during common activities of daily living. It includes 16 questions which participant give a percentage confidence response with 0% being not confident at all and 100% being completely confident. There is also a total score out from 0% (least confident) to 100% (most confident) for overall balance confidence, which average created by combining the scores given for the separate questions.	Assessed during a single clinical assessment at baseline.
Secondary	Walking distance in metres	Assessed using the six-minute walk test in clinical setting.	Assessed during a single clinical assessment at baseline.
Secondary	Patient experience as assessed by semi-structured interviews	The patients experience assessed by semi-structured interviews in focus group.	1 hour.
Secondary	Physical Activity: Movement intensity (in average body acceleration (g) during activity)	Movement intensity measurement is assessed using the fixed body sensor worn during activity monitoring at home.	7 days.
Secondary	Physical activity: types of activity (time in minutes spent standing, walking, lying, sitting, cycling, running) assessed with activity monitor.	Types of activity (time measured in minutes spent standing, walking, lying, sitting, cycling, running) is assessed using the fixed body sensor worn during activity monitoring at home.	7 days.
Secondary	Timed Up and Go (TUG)	Time in seconds to complete the standard TUG protocol	Assessed during a single clinical assessment at baseline.
Secondary	Functional reach test	Assessed using standard functional reach protocol	Assessed during a single clinical assessment at baseline.