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出境医 / 临床实验 / Activity, Balance and COPD (ABCOPD) (ABCOPD)

Activity, Balance and COPD (ABCOPD) (ABCOPD)

Study Description
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.

Condition or disease Intervention/treatment
COPD 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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 82 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Activity, Balance and COPD: An Exploratory Study of Physical Activity and Balance in Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : March 2022
Arms 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.

Outcome Measures
Primary Outcome Measures :
  1. Free-living gait stability as assessed by activity monitor [ Time Frame: 7 days. ]
    The free-living gait stability parameters derived from the fixed body sensor worn during activity monitoring at home.


Secondary Outcome Measures :
  1. Physical activity assessed by step count using activity monitor [ Time Frame: 7 days. ]
    Physical activity assessed using step count (number of steps), as assessed using the activity monitor at home (McRoberts MoveMonitor).

  2. Clinical balance assessment [ Time Frame: Assessed during single clinical assessement at baseline. ]
    Assessed using the miniBESTest in clinical setting.

  3. Physical performance assessment [ Time Frame: Assessed during single clinical assessment at baseline. ]
    Assessed using the Short Physical Performance Battery (SPPB) in clinical setting.

  4. Balance confidence [ Time Frame: Assessed during a single clinical assessment at baseline. ]
    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.

  5. Walking distance in metres [ Time Frame: Assessed during a single clinical assessment at baseline. ]
    Assessed using the six-minute walk test in clinical setting.

  6. Patient experience as assessed by semi-structured interviews [ Time Frame: 1 hour. ]
    The patients experience assessed by semi-structured interviews in focus group.

  7. Physical Activity: Movement intensity (in average body acceleration (g) during activity) [ Time Frame: 7 days. ]
    Movement intensity measurement is assessed using the fixed body sensor worn during activity monitoring at home.

  8. Physical activity: types of activity (time in minutes spent standing, walking, lying, sitting, cycling, running) assessed with activity monitor. [ Time Frame: 7 days. ]
    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.

  9. Timed Up and Go (TUG) [ Time Frame: Assessed during a single clinical assessment at baseline. ]
    Time in seconds to complete the standard TUG protocol

  10. Functional reach test [ Time Frame: Assessed during a single clinical assessment at baseline. ]
    Assessed using standard functional reach protocol


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with stable chronic lung disease.
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.
Contacts and Locations

Contacts
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Contact: Keir EJ Philip, MRCP 0044(0)2073528121 ext 8029 k.philip@imperial.ac.uk

Locations
Layout table for location information
United Kingdom
National Heart and Lung Institute, Imperial College London Recruiting
London, United Kingdom
Contact: Keir EJ Philip, MRCP         
Sponsors and Collaborators
Imperial College London
Investigators
Layout table for investigator information
Principal Investigator: Nicholas Hopkinson, PhD Imperial College London
Tracking Information
First Submitted Date June 24, 2019
First Posted Date July 2, 2019
Last Update Posted Date December 17, 2019
Actual Study Start Date June 24, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
Free-living gait stability as assessed by activity monitor [ Time Frame: 7 days. ]
The free-living gait stability parameters derived from the fixed body sensor worn during activity monitoring at home.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2019)
  • Physical activity assessed by step count using activity monitor [ Time Frame: 7 days. ]
    Physical activity assessed using step count (number of steps), as assessed using the activity monitor at home (McRoberts MoveMonitor).
  • Clinical balance assessment [ Time Frame: Assessed during single clinical assessement at baseline. ]
    Assessed using the miniBESTest in clinical setting.
  • Physical performance assessment [ Time Frame: Assessed during single clinical assessment at baseline. ]
    Assessed using the Short Physical Performance Battery (SPPB) in clinical setting.
  • Balance confidence [ Time Frame: Assessed during a single clinical assessment at baseline. ]
    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.
  • Walking distance in metres [ Time Frame: Assessed during a single clinical assessment at baseline. ]
    Assessed using the six-minute walk test in clinical setting.
  • Patient experience as assessed by semi-structured interviews [ Time Frame: 1 hour. ]
    The patients experience assessed by semi-structured interviews in focus group.
  • Physical Activity: Movement intensity (in average body acceleration (g) during activity) [ Time Frame: 7 days. ]
    Movement intensity measurement is assessed using the fixed body sensor worn during activity monitoring at home.
  • Physical activity: types of activity (time in minutes spent standing, walking, lying, sitting, cycling, running) assessed with activity monitor. [ Time Frame: 7 days. ]
    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.
  • Timed Up and Go (TUG) [ Time Frame: Assessed during a single clinical assessment at baseline. ]
    Time in seconds to complete the standard TUG protocol
  • Functional reach test [ Time Frame: Assessed during a single clinical assessment at baseline. ]
    Assessed using standard functional reach protocol
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with stable chronic lung disease.
Condition COPD
Intervention Other: No intervention being delivered.
No interventions are being delivered.
Study Groups/Cohorts
  • Main study group
    31 people with COPD and 31 controls in the main study group.
    Intervention: Other: No intervention being delivered.
  • six-minute walk substudy
    We will aim to have 40 participants participating in the 6 minute walk sub-study.
    Intervention: Other: No intervention being delivered.
  • Qualitative dance substudy
    We will aim for 20 participants.
    Intervention: Other: No intervention being delivered.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 1, 2019)
82
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Keir EJ Philip, MRCP 0044(0)2073528121 ext 8029 k.philip@imperial.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04006015
Other Study ID Numbers IRAS Project ID: 258399
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor Imperial College London
Collaborators Not Provided
Investigators
Principal Investigator: Nicholas Hopkinson, PhD Imperial College London
PRS Account Imperial College London
Verification Date December 2019