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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202991
• Other study ID #: 13418ca
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: December 18, 2019

Study information

• Verified date: April 2022
• Source: Teesside University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Balance Impairment
• Chronic Obstructive Pulmonary Disease
• Gait Impairment
• Lung Diseases
• Lung Diseases, Obstructive
• Pain
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Exposure - pain
Groups are defined by their naturally occurring exposure to pain or not

Locations

Country	Name	City	State
United Kingdom	South Tees Hospitals NHS Trust	Middlesbrough
United Kingdom	North Tees Hospitals NHS Trust	Stockton-on-Tees

Sponsors (3)

Lead Sponsor	Collaborator
Teesside University	North Tees and Hartlepool NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	PiMax	Maximum inspiratory pressure measured by a hand held device that participants take an inward breath in to.	5 minutes
Other	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
Other	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
Primary	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	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
Secondary	Gait analysis	Temporospatial gait analysis using the 'Gaitrite' walkway.	10 minutes