Pain in Individuals With COPD During Pulmonary Rehabilitation

NCT02979379 | Completed

• 1 other identifier: 16-001-WP
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed at determining the role of pain in individuals with chronic obstructive pulmonary disease (COPD) who are enrolled in a pulmonary rehabilitation (PR) program. It is not known whether pain interferes with an individuals performance in PR, or whether PR aggravates or relieves pain. Individuals with COPD who report chronic pain and those without pain will be enrolled in the study.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change in qualities of pain (intensity, location, interference)

  Change from Baseline to end of 8-Week PR program

Secondary Outcomes (3)

• Change in coping ability specific to pain and fear avoidance

  Change from Baseline to end of 8-Week PR program

• Relationship between depression and other psychological factors influencing chronic pain, including coping ability and fear avoidance behaviour

  Change from Baseline to end of 8-Week PR program

• Change in functional exercise capacity and health related quality of life between those with chronic pain and those without pain

  Change from Baseline to end of 8-Week PR program

Study Arms (2)

Pain

Individuals with COPD who experience chronic pain (episodes of daily pain for a duration greater than three months)

Other: Pain

No Pain

Individuals with COPD who do not experience pain on a regular basis.

Other: Pain

Interventions

Pain OTHER

No Pain; Pain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with moderate to severe COPD enrolled in an out-patient pulmonary rehabilitation program

You may qualify if:

• individuals with moderate to severe COPD based on international (GOLD) criteria
• clinically stable
• no history of acute exacerbation in the past 6 weeks
• able to provide their own informed consent
• referred to out-patient pulmonary rehabilitation at West Park Healthcare Centre

You may not qualify if:

• primary diagnosis other than COPD
• known cognitive impairment that would interfere with completing surveys
• cardiac, neurological or orthopedic conditions which prevent the ability to undertake exercise safely

Sponsors & Collaborators

• West Park Healthcare Centre: lead

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: December 1, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: March 3, 2020
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

CA (1)