- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02979379
Pain in Individuals With COPD During Pulmonary Rehabilitation
Does Pulmonary Rehabilitation Aggravate or Relieve Symptoms of Pain in Individuals With COPD
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6M 2J5
- West Park Healthcare Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pain
Individuals with COPD who experience chronic pain (episodes of daily pain for a duration greater than three months)
|
|
No Pain
Individuals with COPD who do not experience pain on a regular basis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in qualities of pain (intensity, location, interference)
Time Frame: Change from Baseline to end of 8-Week PR program
|
Change from Baseline to end of 8-Week PR program
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in coping ability specific to pain and fear avoidance
Time Frame: Change from Baseline to end of 8-Week PR program
|
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
Time Frame: Change from Baseline to end of 8-Week PR program
|
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
Time Frame: Change from Baseline to end of 8-Week PR program
|
Change from Baseline to end of 8-Week PR program
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-001-WP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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