Understanding Balance Impairment in COPD

NCT05984498 | Unknown DMC

• 2 other identifiers: 2022 Aug 10959 HarrisonNIHR300856
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational study investigating the mechanisms of balance problems in people with COPD and how COPD impacts them living their daily lives. The main objectives of this study are:

• To quantify the relationship between balance and aspects of neuromuscular function in individuals with COPD, and compared to age-matched healthy controls
• To understand the lived experience of people with COPD and their carers Participants will attend an appointment at the University rehab lab to:
• Complete a balance test
• Fill out some questionnaires on mood, health status and balance and falls
• Complete some walking tests
• Have their body composition measured
• Have the function and strength of their leg nerves and muscles tested Researchers will compare people with COPD and healthy controls (older adults without COPD or other conditions known to impact balance) to see if any of the things measured are impacting the balance of people with COPD more than their peers without COPD.
• For 10 people with COPD only they will be visited at home to observe how they carry out everyday tasks and 5 of those 10 will have a follow up interview. Researchers will take notes and record interviews and look for similarities and interesting points in the notes and transcripts of the interviews to build a picture of what living with COPD is like.

Conditions

Chronic Obstructive Pulmonary Disease; Healthy Volunteers

Keywords

Chronic, Obstructive Pulmonary Disease; Balance; Falls; Nerve Function; Muscle Function; Lived Experience

Outcome Measures

Primary Outcomes (1)

• Balance Evaluation Systems Test (BESTest)

  27 functional tasks scored on a 0-3 scale to give an overall percentage out from a maximum of 108 points. Higher scores indicate better balance.

  baseline only

Secondary Outcomes (17)

• The Activities- Specific Balance Confidence Scale (ABC)

  baseline only

• The Elderly Falls Screening Test

  baseline only

• Incremental Shuttle Walk Test

  baseline only

• COPD Assessment Test

  baseline only

• Medical Research Council Dyspnoea Scale

  baseline only

Study Arms (2)

COPD group

People with a spirometry confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

Healthy Controls

Older adults over the age of 55 who do not have COPD

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with COPD and people without COPD living in community settings in the North East of England, UK

You may qualify if:

• COPD
• Have a spirometry confirmed diagnosis of COPD as per GOLD guidelines
• Stable COPD (six weeks clear of exacerbation)
• years or over at the point of recruitment
• Able to communicate with good verbal English or use adaptive equipment to communicate
• Male or female Controls
• Free from a diagnosis of COPD (confirmed by spirometry)
• years or over at the point of recruitment
• Able to communicate with good verbal English or use adaptive equipment to
• Communicate
• Male or female

You may not qualify if:

• COPD
• Recent exacerbation of COPD (within the last six weeks)
• Under 55 years of age at the point of recruitment
• Any neurological or musculoskeletal diagnoses (e.g., strokes, Parkinson's disease or chronic pain that interferes with ability to safely complete the tests
• Unable to provide written informed consent
• Unable to speak English or no translation options available
• Diagnosed but not corrected visual, vestibular disturbance and peripheral neuropathy
• Vasovagal syncope
• Not independent living (e.g., living in a care home or prison) Controls
• Abnormal lung function (FEV1 and FVC equal to or greater than 80% and FEV1/FVC equal to greater than 70%)
• Under 55 years of age at the point of recruitment
• Any neurological or musculoskeletal impairment that would significantly affect balance impacting ability to safely complete the assessments
• Unable to provide written informed consent
• Unable to speak English or no translation options available
• Any uncorrected visual or somatosensory disturbance

Sponsors & Collaborators

• Teesside University: lead

Study Sites (1)

Teesside University

Middlesbrough, TS1 3BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samantha L Harrison, PhD

  Teesside University

  STUDY CHAIR

Central Study Contacts

Kirsti J Loughran, PhD

CONTACT

01642 342934; k.loughran@tees.ac.uk

Samantha L Harrison, PhD

CONTACT

01642 738412; s.l.harrison@tees.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Rehabilitation

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 9, 2023
• Study Start: July 17, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

GB (1)