Chronic Obstructive Pulmonary DiseaseNCT04202991
The Relationship Between Pain, Balance and Gait in People With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Balance Impairment, run by Teesside University at 2 sites in United Kingdom.
Trial summary
The balance, gait and pain in Chronic Obstructive Pulmonary Disease (COPD) study will aim to investigate the link between balance and gait impairment, and high rates of pain in people with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Balance Impairment, Gait Impairment
- What is being tested?
- Exposure - pain
- How many people
- 43 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 May 2019to 18 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with COPD referred to, or attending, Pulmonary Rehabilitation at local National Health Service Hospitals/Clinics
Who may be able to join
- Have a spirometry confirmed diagnosis of COPD as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
- Be 18 years or over at the point of recruitment
- Be able to communicate with good verbal English or use adaptive equipment to communicate.
- Be able to complete test procedures
- Stable COPD (six weeks clear of exacerbation)
- No uncorrected visual or somatosensory disturbance
Who cannot join
- No other conditions that may affect balance or gait e.g. neurological or vestibular conditions
- Recent exacerbation of COPD (within the last six weeks)
- Unable to provide written informed consent
- Unable to speak English or no translation options available
- Any other acute health conditions that would make activity unsafe e.g. acute infection, unstable cardiac disease.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
South Tees Hospitals NHS Trust
Middlesbrough, TS4 3BW
North Tees Hospitals NHS Trust
Stockton-on-Tees, TS19 8PE
About this study
Official title: An Investigation of the Relationship of Pain With Balance and Gait Impairment in People With Chronic Obstructive Pulmonary Disease
The balance, gait and pain in Chronic Obstructive Pulmonary Disease (COPD) study will aim to investigate the link between balance and gait impairment, and high rates of pain in people with COPD. This cross-sectional observational study will compare balance and gait outcomes for people with COPD who have pain, to those who are pain free.
- Being tested
- Exposure - pain
- Keywords
- COPD, balance, gait, pain
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure - painOther
Groups are defined by their naturally occurring exposure to pain or not
| Study group | Role | What they receive |
|---|---|---|
| COPD with pain | People with COPD who also report pain more often than not over the previous 3 months Receives: Other: Exposure - pain | |
| COPD with no pain | People with COPD who do not report pain more often than not over the previous 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Evaluations Systems Test (BESTest)
BESTest is a quantitative assessment tool that identifies disordered systems underlying postural control that are responsible for poor functional balance. It was developed for clinicians to differentiate balance problems into six underlying systems that may constrain balance. It was developed from the theoretical understanding of balance control systems based on Bernstein's concept that postural control results from a set of interacting systems. It has 36 items that evaluate performance of 6 balance systems: bio-mechanical constraints, stability limits/verticality, anticipatory responses, postural responses, sensory orientation, and stability in gait. A higher score indicates better balance.
Measured: 20-30 minutes
Secondary outcomes (2)
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. A total score of 56 is available, higher scores indicate better balance.
Measured: 5 minutes (for additional items not featured within the BESTest
Gait analysis
Temporospatial gait analysis using the 'Gaitrite' walkway.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 May 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust, North Tees and Hartlepool NHS Foundation Trust
- Responsible party
- Principal investigator, Samantha Harrison, Teesside University
- Investigators
- Samantha L Harrison, PhD, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202991
- Sponsor's protocol ID
- 13418ca
- Status last verified
- Apr 2022
- First submitted
- 16 Dec 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be retained indefinitely in anonymised format and shared on reasonable request
Publications
Loughran KJ, Trewartha G, Martin D, Fernandes-James C, Shea R, Dixon J, Tough D, Harrison SL. Persistent pain is associated with poorer balance and gait performance for people with Chronic Obstructive Pulmonary Disease. Respir Med. 2025 Jul;243:108133. doi: 10.1016/j.rmed.2025.108133. Epub 2025 Apr 28.
PubMed 40306330
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Relationship of Pain With Balance and Gait Impairment in People With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04202991
- Acronym / sponsor ID
- 13418ca
- Keywords
- COPD, balance, gait, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust, North Tees and Hartlepool NHS Foundation Trust
- Study start
- 1 May 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 18 Dec 2019 (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.
The balance, gait and pain in Chronic Obstructive Pulmonary Disease (COPD) study will aim to investigate the link between balance and gait impairment, and high rates of pain in people with COPD. This cross-sectional observational study will compare balance and gait outcomes for people with COPD who have pain, to those who are pain free.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD with pain | – | Other: Exposure - painPeople with COPD who also report pain more often than not over the previous 3 months |
| COPD with no pain | – | –People with COPD who do not report pain more often than not over the previous 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with COPD referred to, or attending, Pulmonary Rehabilitation at local National Health Service Hospitals/Clinics
Key inclusion criteria (6 listed)
- Have a spirometry confirmed diagnosis of COPD as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
- Be 18 years or over at the point of recruitment
- Be able to communicate with good verbal English or use adaptive equipment to communicate.
- Be able to complete test procedures
- Stable COPD (six weeks clear of exacerbation)
Key exclusion criteria (5 listed)
- No other conditions that may affect balance or gait e.g. neurological or vestibular conditions
- Recent exacerbation of COPD (within the last six weeks)
- Unable to provide written informed consent
- Unable to speak English or no translation options available
- Any other acute health conditions that would make activity unsafe e.g. acute infection, unstable cardiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure - painGroups are defined by their naturally occurring exposure to pain or not | Other | COPD with pain |
Primary outcome
Balance Evaluations Systems Test (BESTest)
Time frame: 20-30 minutes
BESTest is a quantitative assessment tool that identifies disordered systems underlying postural control that are responsible for poor functional balance. It was developed for clinicians to differentiate balance problems into six underlying systems that may constrain balance. It was developed from the theoretical understanding of balance control systems based on Bernstein's concept that postural control results from a set of interacting systems. It has 36 items that evaluate performance of 6 balance systems: bio-mechanical constraints, stability limits/verticality, anticipatory responses, postural responses, sensory orientation, and stability in gait. A higher score indicates better balance.
2 secondary outcomes
Berg Balance Scale
Time frame: 5 minutes (for additional items not featured within the BESTest
Gait analysis
Time frame: 10 minutes
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 27 Apr 2022.
- Derived from this study: PubMed 40306330Loughran KJ, Trewartha G, Martin D, Fernandes-James C, Shea R, Dixon J, Tough D, Harrison SL. Persistent pain is associated with poorer balance and gait performance for people with Chronic Obstructive Pulmonary Disease. Respir Med. 2025 Jul;243:108133. doi: 10.1016/j.rmed.2025.108133. Epub 2025 Apr 28.
- Individual participant dataSharing planned: Yes. Data will be retained indefinitely in anonymised format and shared on reasonable request
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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 principal investigator
Teesside University
2 sites 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 Balance Impairment, run by Teesside University at 2 sites 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 6 inclusion and 5 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Evaluations Systems Test (BESTest) (time frame: 20-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202991, which also lists 1 linked publication.
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 27 Apr 2022.