Pain in Individuals With COPD During Pulmonary Rehabilitation

NCT ID: NCT02979379

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-03-03

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.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a systemic disease associated with dyspnea, fatigue, and poor health-related quality of life. COPD is further complicated by the presence of pain which may be attributed to common comorbidities such as musculoskeletal conditions (osteoarthritis, osteoporosis), cardiac disease or diabetes. Pulmonary rehabilitation (PR) is the cornerstone of treatment for COPD however the impact of pain on PR has not been explored. It is unclear whether those experiencing chronic pain achieve a similar, lesser or greater degree of benefit compared to those without pain, or whether exercise training exacerbates symptoms. Gaining a greater understanding of the effects of an outpatient PR program on pain will provide direction into future specific treatment options which may necessary for managing chronic pain as part of PR.

Individuals with COPD who are beginning an out-patient PR program will be enrolled in the study. Those who report the presence of chronic pain will be classed as the pain group; those who report the absence of chronic pain will be classed as the comparator group. All participants will complete a 6-minute walk test and a Chronic Respiratory Disease Questionnaire (CRDQ) at the beginning of the PR program. These measures will be repeated at the end of the 8-week PR program for all participants. All participants will be asked to report their level of pain using a visual analogue scale every two weeks during the PR program.

Participants reporting chronic pain will also complete a series of questionnaires regarding their pain and coping strategies. These include; the Brief Pain Inventory (BPI), Coping Strategies Questionnaire (CSQ), Fear Avoidance Behavior Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Centre for Epidemiological Studies for Depression Survey (CES-D).

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Pain

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

Pain

Intervention Type: OTHER

No Pain

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

Pain

Intervention Type: OTHER

Interventions

Pain

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Park Healthcare Centre

OTHER

Sponsor Role: lead

Responsible Party

Roger Goldstein

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West Park Healthcare Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

16-001-WP

Identifier Type: -

Identifier Source: org_study_id