Clinical trial NCT05984498: Understanding Balance Impairment in COPD
Official title: An Investigation of the Physiological and Psychosocial Mechanisms Underpinning Balance Impairment in People With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Healthy Volunteers
Keywords: Chronic, Obstructive Pulmonary Disease
Balance
Falls
Nerve Function
Muscle Function
Lived Experience
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

Detailed 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.

Eligibility criteria: 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 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 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
* Vasovagal syncope
* Living in a care home or in prison

Primary outcomes:
measure: Balance Evaluation Systems Test (BESTest)
timeFrame: baseline only
Secondary outcomes:
measure: The Activities- Specific Balance Confidence Scale (ABC)
timeFrame: baseline only
measure: The Elderly Falls Screening Test
timeFrame: baseline only
measure: Incremental Shuttle Walk Test
timeFrame: baseline only
measure: COPD Assessment Test
timeFrame: baseline only
measure: Medical Research Council Dyspnoea Scale
timeFrame: baseline only
measure: Lung function testing (spirometry) Forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FEV1/FVC)
timeFrame: baseline only
measure: Patient Health Questionnaire-9 (depression)
timeFrame: baseline only
measure: Generalised Anxiety Disorder-7 Questionnaire (anxiety)
timeFrame: baseline only
measure: Brief Pain Inventory
timeFrame: baseline only
measure: Somatosensory accuracy
timeFrame: baseline only
measure: Maximal Voluntary Contraction Strength
timeFrame: baseline only
measure: Voluntary Activation Test
timeFrame: baseline only
measure: Hoffman's Reflex
timeFrame: baseline only
measure: Maximum grip strength
timeFrame: baseline only
measure: Physical Activity Monitor
timeFrame: baseline through to 7 days
measure: EuroQOL-5D-5Level
timeFrame: baseline only
measure: Bioelectrical impendence analysis to record whole body composition of muscle, bone and fat
timeFrame: baseline only
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University
Study officials:
affiliation: Teesside University
name: Samantha L Harrison, PhD
role: STUDY_CHAIR
References: