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

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 Overview

• Status: Completed
• Conditions: Pain; Chronic Obstructive Pulmonary Disease; Balance Impairment; Gait Impairment
• Intervention / Treatment: Other: Exposure - pain

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesbrough, United Kingdom, TS4 3BW
    • South Tees Hospitals NHS Trust
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • North Tees Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People with COPD referred to, or attending, Pulmonary Rehabilitation at local National Health Service Hospitals/Clinics

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD with pain; People with COPD who also report pain more often than not over the previous 3 months	Other: Exposure - pain; Groups are defined by their naturally occurring exposure to pain or not
COPD with no pain; People with COPD who do not report pain more often than not over the previous 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20-30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes (for additional items not featured within the BESTest
Gait analysis	Temporospatial gait analysis using the 'Gaitrite' walkway.	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 second sit to stand test	The 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.	30 seconds
Peak muscle torque (quadriceps, hamstrings, hip abductors and adductors, ankle plantar flexors and dorsiflexors).	Muscle strength testing using the Biodex dynamometer. A higher peak torque in Nm indicates better muscle strength.	30 minutes
PiMax	Maximum inspiratory pressure measured by a hand held device that participants take an inward breath in to.	5 minutes
Brief Pain Inventory Short Form	The 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.	5 minutes
Physical Activity Scale for the Elderly	The 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.	5 minutes

Collaborators and Investigators

• Sponsor: Teesside University
• Collaborators: South Tees Hospitals NHS Foundation Trust; North Tees and Hartlepool NHS Foundation Trust
• Investigators: Principal Investigator: Samantha L Harrison, PhD, Teesside University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: COPD, balance, gait, pain
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 13418ca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be retained indefinitely in anonymised format and shared on reasonable request
• IPD Sharing Time Frame: Once data has been analysed and available indefinitely
• IPD Sharing Access Criteria: On request to lead publishing author
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No