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

NCT04202991 | Completed

• 1 other identifier: 13418ca
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

COPD, balance, gait, pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Berg Balance Scale

  5 minutes (for additional items not featured within the BESTest

• Gait analysis

  10 minutes

Other Outcomes (5)

• 30 second sit to stand test

  30 seconds

• Peak muscle torque (quadriceps, hamstrings, hip abductors and adductors, ankle plantar flexors and dorsiflexors).

  30 minutes

• PiMax

  5 minutes

Study Arms (2)

COPD with pain

People with COPD who also report pain more often than not over the previous 3 months

Other: Exposure - pain

COPD with no pain

People with COPD who do not report pain more often than not over the previous 3 months

Interventions

Exposure - pain OTHER

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

COPD with pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teesside University: lead
• South Tees Hospitals NHS Foundation Trust: collaborator
• North Tees and Hartlepool NHS Foundation Trust: collaborator

Study Sites (2)

South Tees Hospitals NHS Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

North Tees Hospitals NHS Trust

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pain

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Samantha L Harrison, PhD

  Teesside University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Lecturer in Research and Innovation

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: May 1, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once data has been analysed and available indefinitely
• Access Criteria: On request to lead publishing author

Locations

GB (2)