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Completed

NCT Number: NCT04202991

The Relationship Between Pain, Balance and Gait 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

South Tees Hospitals NHS Trust, Middlesbrough, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure - pain

Other

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

Primary outcomes

  1. Balance Evaluations Systems Test (BESTest)

    Time frame: 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 outcomes

  1. Berg Balance Scale

    Time frame: 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.

  2. Gait analysis

    Time frame: 10 minutes

    Temporospatial gait analysis using the 'Gaitrite' walkway.

Other outcomes

  1. 30 second sit to stand test

    Time frame: 30 seconds

    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.

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

    Time frame: 30 minutes

    Muscle strength testing using the Biodex dynamometer. A higher peak torque in Nm indicates better muscle strength.

  3. PiMax

    Time frame: 5 minutes

    Maximum inspiratory pressure measured by a hand held device that participants take an inward breath in to.

  4. Brief Pain Inventory Short Form

    Time frame: 5 minutes

    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. Physical Activity Scale for the Elderly

    Time frame: 5 minutes

    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.

Sponsors and collaborators

Lead sponsor

Teesside University

Other

Collaborators

  • North Tees and Hartlepool NHS Foundation Trust
  • South Tees Hospitals NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2019
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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