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

Completed

• Conditions: Balance Impairment; Pain; Chronic Obstructive Pulmonary Disease; Gait Impairment
• Interventions: Other: Exposure - pain

• Registration Number: NCT04202991
• Lead Sponsor: Teesside University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Primary Completion: 2019-12-18
• Study Completion: 2019-12-18
• Study First Posted: 2019-12-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD with pain	Exposure - pain	People with COPD who also report pain more often than not over the previous 3 months

Primary Outcome Measures

Name	Time	Method
Balance Evaluations Systems Test (BESTest)	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.

Secondary Outcome Measures

Name	Time	Method
Gait analysis	10 minutes	Temporospatial gait analysis using the 'Gaitrite' walkway.
Berg Balance Scale	5 minutes (for additional items not featured within the BESTest	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.

Trial Locations

Locations (2)

North Tees Hospitals NHS Trust; 🇬🇧 Stockton-on-Tees, United Kingdom

South Tees Hospitals NHS Trust; 🇬🇧 Middlesbrough, United Kingdom