Understanding Balance Impairment in COPD

Sponsor

Teesside University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05984498

Collaborator

(none)

Enrollment

Location

9.5

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Healthy Volunteers

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

An Investigation of the Physiological and Psychosocial Mechanisms Underpinning Balance Impairment in People With Chronic Obstructive Pulmonary Disease

Actual Study Start Date :

Jul 17, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Balance Evaluation Systems Test (BESTest) [baseline only]
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.

Secondary Outcome Measures

The Activities- Specific Balance Confidence Scale (ABC) [baseline only]
A questionnaire that assesses confidence for performing 16 activities without a loss of balance. Scores for each item range between 0 (not confident) and 100% (completely confident). The total score for each item is divided by the number of items (16).
The Elderly Falls Screening Test [baseline only]
A questionnaire and test that involves three questions relating to falls history in the previous 12-months and a gait speed and pattern assessment over a 5-meter course to establish falls risk. Score out of 5 with higher scores indicating a greater risk of falls.
Incremental Shuttle Walk Test [baseline only]
A walking test where participants walk between two cones that are 10 meters apart to a increasingly frequent paced beep to measure exercise capacity. The diatnace walked is reported to the nearest 10m.
COPD Assessment Test [baseline only]
A questionnaire measuring COPD health related quality of life. Scored between 0 and 40 with higher scores indicating the greatest impact of COPD on quality of life.
Medical Research Council Dyspnoea Scale [baseline only]
A one question scale (0-4) of the impact of breathlessness with higher scores indicating greater impact of symptoms.
Lung function testing (spirometry) Forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FEV1/FVC) [baseline only]
A measure of lung function used to define COPD. Participants blow into a handheld spirometry device. FEV1 and FEV1 / FVC will be recorded.
Patient Health Questionnaire-9 (depression) [baseline only]
A one page questionnaire that measures symptoms of depression and low mood. Scored out of 27 with higher scores indicated greater symptoms of depression.
Generalised Anxiety Disorder-7 Questionnaire (anxiety) [baseline only]
A one page questionnaire that measures symptoms of anxiety. Scored out of 21 with higher scores indicating worse symptoms of depression.
Brief Pain Inventory [baseline only]
A two page questionnaire that records pain, pain intensity, pain location and pain interference. It consists of 9 items which are rated 0-10 with higher scores indicating a greater severity of pain.
Somatosensory accuracy [baseline only]
Vibration sensation perception will be measured with a neurothesiometer device on both big toes.
Maximal Voluntary Contraction Strength [baseline only]
The maximal strength that participants can generate in their thigh and calf muscles will be measured with a biodex dynamometer
Voluntary Activation Test [baseline only]
The amount of muscle available on top of a voluntary contraction in the quadriceps muscle will be measured using the biodex dynamometer and an electrical stimulus over the thigh muscles (Interpolated Twitch Technique)
Hoffman's Reflex [baseline only]
The speed and size of nerve response to a stimulus that mimics balance reactions will be measured in the tibial nerve by placing a small bar over the back of the knee that gives an electrical stimulus to the nerve.
Maximum grip strength [baseline only]
Participants hold a handheld dynamometer in their hands and squeeze the device to measure grip strength.
Physical Activity Monitor [baseline through to 7 days]
Participants will be asked to wear a watch sized device (Actigraph Physical Activity Monitor) on their wrists for 7 days. The actigraph device measures levels of physical activity
EuroQOL-5D-5Level [baseline only]
The EQ-5D-5L descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION) and each dimension has five response levels (no problems to unable/severe problems). Responses form a 5 digit code. no problems, slight problems, moderate problems, severe problems, unable to /extreme problems.
Bioelectrical impendence analysis to record whole body composition of muscle, bone and fat [baseline only]
A bioelectrical impedance device (Tanita BIA) will record measures of body composition

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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