Understanding Balance Impairment in COPD

Phase

N/A

Condition

Healthy Volunteers

Treatment

N/A

Clinical Study ID

NCT05984498

2022 Aug 10959 Harrison

NIHR300856

Ages > 55
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: COPD

Have a spirometry confirmed diagnosis of COPD as per GOLD guidelines
Stable COPD (six weeks clear of exacerbation)
55 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)
55 years or over at the point of recruitment
Able to communicate with good verbal English or use adaptive equipment to
Communicate
Male or female

Exclusion

Exclusion Criteria: 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 orchronic 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 equalto greater than 70%)
Under 55 years of age at the point of recruitment
Any neurological or musculoskeletal impairment that would significantly affect balanceimpacting 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
Vasovagal syncope
Living in a care home or in prison

Study Design

July 17, 2023

May 01, 2024

Study Description

Chronic obstructive pulmonary disease (COPD) is a progressive condition that affects around 1.2million people in the UK. Breathlessness is the main symptom but people with COPD are also more likely to fall than healthy people of the same age. Falling has emotional consequences, such as feelings of shame, embarrassment and fear of falling in public which leads to avoidance of outdoor activities. Researchers do not know why people with COPD fall more but they have poor balance which may, in part, be due to problems with sensory and muscle responses that would usually maintain balance. Symptoms of breathlessness and pain, plus inactivity, may further impact balance. Physical and social environments may also have a role in falls risk, but this has yet to be investigated. Pulmonary Rehabilitation (PR) which includes stamina and strength exercises, alongside education and emotional support is standard treatment for COPD but it does not include any balance exercises, meaning people with COPD who are at a greater risk of falling do not receive any routine treatment to improve balance. This study aims to investigate the physical, psychological, social and environmental factors impacting on balance in people with COPD by comparing them to older adults without COPD. The study will recruit from local hospital services (people with COPD and their carers without COPD) and within the community (healthy older adults). Balance, muscle function (size, strength and speed of nerve conduction) and physical activity will be measured, and the two groups compared. Researchers will also observe patients in their own homes and do follow up interviews to understand what it is like to live with COPD and the challenges people face. The information from this study will be used in conjunction with stakeholders to co design an intervention to improve balance in people with COPD.

Connect with a study center

Teesside University
Middlesbrough, TS1 3BX
United Kingdom
Active - Recruiting

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