Chronic Obstructive Pulmonary DiseaseNCT05984498
Understanding Balance Impairment in COPD
An observational study of Chronic Obstructive Pulmonary Disease and Healthy Volunteers, run by Teesside University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Healthy Volunteers
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People living with COPD and people without COPD living in community settings in the North East of England, UK
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of the Physiological and Psychosocial Mechanisms Underpinning Balance Impairment in People With Chronic Obstructive Pulmonary Disease
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:
Read more
- 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.
Read the 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.
- Keywords
- Chronic, Obstructive Pulmonary Disease, Balance, Falls, Nerve Function, Muscle Function, Lived Experience
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline only
Secondary outcomes (17)
The Activities- Specific Balance Confidence Scale (ABC)
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).
Measured: baseline only
The Elderly Falls Screening Test
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.
Measured: baseline only
Incremental Shuttle Walk Test
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.
Measured: baseline only
COPD Assessment Test
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.
Measured: baseline only
Medical Research Council Dyspnoea Scale
A one question scale (0-4) of the impact of breathlessness with higher scores indicating greater impact of symptoms.
Measured: baseline only
Lung function testing (spirometry) Forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FEV1/FVC)
A measure of lung function used to define COPD. Participants blow into a handheld spirometry device. FEV1 and FEV1 / FVC will be recorded.
Measured: baseline only
Patient Health Questionnaire-9 (depression)
A one page questionnaire that measures symptoms of depression and low mood. Scored out of 27 with higher scores indicated greater symptoms of depression.
Measured: baseline only
Generalised Anxiety Disorder-7 Questionnaire (anxiety)
A one page questionnaire that measures symptoms of anxiety. Scored out of 21 with higher scores indicating worse symptoms of depression.
Measured: baseline only
Brief Pain Inventory
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.
Measured: baseline only
Somatosensory accuracy
Vibration sensation perception will be measured with a neurothesiometer device on both big toes.
Measured: baseline only
Maximal Voluntary Contraction Strength
The maximal strength that participants can generate in their thigh and calf muscles will be measured with a biodex dynamometer
Measured: baseline only
Voluntary Activation Test
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)
Measured: baseline only
Hoffman's Reflex
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.
Measured: baseline only
Maximum grip strength
Participants hold a handheld dynamometer in their hands and squeeze the device to measure grip strength.
Measured: baseline only
Physical Activity Monitor
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
Measured: baseline through to 7 days
EuroQOL-5D-5Level
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.
Measured: baseline only
Bioelectrical impendence analysis to record whole body composition of muscle, bone and fat
A bioelectrical impedance device (Tanita BIA) will record measures of body composition
Measured: baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start17 Jul 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Harrison, Teesside University
- Investigators
- Samantha L Harrison, PhD, Study chair, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984498
- Sponsor's protocol ID
- 2022 Aug 10959 Harrison
- Other IDs
- NIHR300856
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Physiological and Psychosocial Mechanisms Underpinning Balance Impairment in People With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05984498
- Acronym / sponsor ID
- 2022 Aug 10959 Harrison
- Keywords
- Chronic, Obstructive Pulmonary Disease, Balance, Falls, Nerve Function, Muscle Function, Lived Experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People living with COPD and people without COPD living in community settings in the North East of England, UK
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Balance Evaluation Systems Test (BESTest)
Time frame: 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.
17 secondary outcomes
The Activities- Specific Balance Confidence Scale (ABC)
Time frame: baseline only
The Elderly Falls Screening Test
Time frame: baseline only
Incremental Shuttle Walk Test
Time frame: baseline only
COPD Assessment Test
Time frame: baseline only
Medical Research Council Dyspnoea Scale
Time frame: baseline only
Lung function testing (spirometry) Forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FEV1/FVC)
Time frame: baseline only
Patient Health Questionnaire-9 (depression)
Time frame: baseline only
Generalised Anxiety Disorder-7 Questionnaire (anxiety)
Time frame: baseline only
Brief Pain Inventory
Time frame: baseline only
Somatosensory accuracy
Time frame: baseline only
Maximal Voluntary Contraction Strength
Time frame: baseline only
Voluntary Activation Test
Time frame: baseline only
Hoffman's Reflex
Time frame: baseline only
Maximum grip strength
Time frame: baseline only
Physical Activity Monitor
Time frame: baseline through to 7 days
EuroQOL-5D-5Level
Time frame: baseline only
Bioelectrical impendence analysis to record whole body composition of muscle, bone and fat
Time frame: baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha L Harrison, PhD study chair
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Healthy Volunteers, run by Teesside University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Evaluation Systems Test (BESTest) (time frame: baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.