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The Relationship Between Pain, Balance and Gait in People With Chronic Obstructive Pulmonary Disease

An Investigation of the Relationship of Pain With Balance and Gait Impairment in People With Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04202991
Enrollment
43
Registered
2019-12-18
Start date
2019-05-01
Completion date
2019-12-18
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance Impairment, Chronic Obstructive Pulmonary Disease, Gait Impairment, Pain

Keywords

COPD, balance, gait, pain

Brief 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. This cross-sectional observational study will compare balance and gait outcomes for people with COPD who have pain, to those who are pain free.

Interventions

OTHERExposure - pain

Groups are defined by their naturally occurring exposure to pain or not

Sponsors

South Tees Hospitals NHS Foundation Trust
CollaboratorOTHER
North Tees and Hartlepool NHS Foundation Trust
CollaboratorOTHER
Teesside University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Balance Evaluations Systems Test (BESTest)20-30 minutesBESTest 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.

Secondary

MeasureTime frameDescription
Berg Balance Scale5 minutes (for additional items not featured within the BESTestThe 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.
Gait analysis10 minutesTemporospatial gait analysis using the 'Gaitrite' walkway.

Other

MeasureTime frameDescription
Brief Pain Inventory Short Form5 minutesThe Brief Pain Inventory is a pain questionnaire which measures the severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. Each item is measured on 0-10 scale, 0 being no pain and 10 being the maximum pain score available.
30 second sit to stand test30 secondsThe 30 Second Sit to Stand Test is also known as 30 second chair stand test, and tests leg strength and endurance in older adults. A higher number of completed sit to stands in 30 seconds indicates better lower limb endurance.
Physical Activity Scale for the Elderly5 minutesThe Physical Activity Scale for the Elderly (PASE) is a questionnaire that combines information on leisure, household and occupational activity. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.
Peak muscle torque (quadriceps, hamstrings, hip abductors and adductors, ankle plantar flexors and dorsiflexors).30 minutesMuscle strength testing using the Biodex dynamometer. A higher peak torque in Nm indicates better muscle strength.
PiMax5 minutesMaximum inspiratory pressure measured by a hand held device that participants take an inward breath in to.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026