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

NCT ID: NCT04202991

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-12-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease Balance Impairment Gait Impairment Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD with pain

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

Exposure - pain

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exposure - pain

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

North Tees and Hartlepool NHS Foundation Trust

OTHER

Sponsor Role collaborator

Teesside University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Samantha Harrison

Principle Lecturer in Research and Innovation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Samantha L Harrison, PhD

Role: PRINCIPAL_INVESTIGATOR

Teesside University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

South Tees Hospitals NHS Trust

Middlesbrough, , United Kingdom

Site Status

North Tees Hospitals NHS Trust

Stockton-on-Tees, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13418ca

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.