Chronic Obstructive Pulmonary DiseaseNCT02979379
Pain in Individuals With COPD During Pulmonary Rehabilitation
An observational study of Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pain
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to 3 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with moderate to severe COPD enrolled in an out-patient pulmonary rehabilitation program
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Pulmonary Rehabilitation Aggravate or Relieve Symptoms of Pain in Individuals With COPD
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.
Read the 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
- Being tested
- Pain
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainOther
| Study group | Role | What they receive |
|---|---|---|
| Pain | Individuals with COPD who experience chronic pain (episodes of daily pain for a duration greater than three months) Receives: Other: Pain | |
| No Pain | Individuals with COPD who do not experience pain on a regular basis. Receives: Other: Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in qualities of pain (intensity, location, interference)
Measured: Change from Baseline to end of 8-Week PR program
Secondary outcomes (3)
Change in coping ability specific to pain and fear avoidance
Measured: 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
Measured: 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
Measured: Change from Baseline to end of 8-Week PR program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979379
- Sponsor's protocol ID
- 16-001-WP
- Status last verified
- Apr 2022
- First submitted
- 1 Sep 2016
- Last updated
- 3 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pulmonary Rehabilitation Aggravate or Relieve Symptoms of Pain in Individuals With COPD
- ClinicalTrials.gov ID
- NCT02979379
- Acronym / sponsor ID
- 16-001-WP
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain | – | Other: PainIndividuals with COPD who experience chronic pain (episodes of daily pain for a duration greater than three months) |
| No Pain | – | Other: PainIndividuals with COPD who do not experience pain on a regular basis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with moderate to severe COPD enrolled in an out-patient pulmonary rehabilitation program
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain | Other | No Pain, Pain |
Primary outcome
Change in qualities of pain (intensity, location, interference)
Time frame: Change from Baseline to end of 8-Week PR program
3 secondary outcomes
Change in coping ability specific to pain and fear avoidance
Time frame: 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in qualities of pain (intensity, location, interference) (time frame: Change from Baseline to end of 8-Week PR program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.