Activity, Balance and COPD (ABCOPD) (ABCOPD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Other: No intervention being delivered.

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.

• Study Type: Observational
• Enrollment (Estimated): 82

Contacts and Locations

• Study Contact: Name: Keir EJ Philip, MRCP; Phone Number: 8029 0044(0)2073528121; Email: k.philip@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • National Heart and Lung Institute, Imperial College London
    • Contact: Keir EJ Philip, MRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults with stable chronic lung disease.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main study group; 31 people with COPD and 31 controls in the main study group.	Other: No intervention being delivered.; No interventions are being delivered.
six-minute walk substudy; We will aim to have 40 participants participating in the 6 minute walk sub-study.	Other: No intervention being delivered.; No interventions are being delivered.
Qualitative dance substudy; We will aim for 20 participants.	Other: No intervention being delivered.; No interventions are being delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Clinical balance assessment	Assessed using the miniBESTest in clinical setting.	Assessed during single clinical assessement at baseline.
Physical performance assessment	Assessed using the Short Physical Performance Battery (SPPB) in clinical setting.	Assessed during single clinical assessment at baseline.
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.
Walking distance in metres	Assessed using the six-minute walk test in clinical setting.	Assessed during a single clinical assessment at baseline.
Patient experience as assessed by semi-structured interviews	The patients experience assessed by semi-structured interviews in focus group.	1 hour.
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.
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.
Timed Up and Go (TUG)	Time in seconds to complete the standard TUG protocol	Assessed during a single clinical assessment at baseline.
Functional reach test	Assessed using standard functional reach protocol	Assessed during a single clinical assessment at baseline.

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Nicholas Hopkinson, PhD, Imperial College London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: IRAS Project ID: 258399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No