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Completed

NCT Number: NCT02979379

Pain in Individuals With COPD During Pulmonary Rehabilitation

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pain

Other

Primary outcomes

  1. Change in qualities of pain (intensity, location, interference)

    Time frame: Change from Baseline to end of 8-Week PR program

Secondary outcomes

  1. Change in coping ability specific to pain and fear avoidance

    Time frame: Change from Baseline to end of 8-Week PR program

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

West Park Healthcare Centre

Other

Registry information

Official study title

Does Pulmonary Rehabilitation Aggravate or Relieve Symptoms of Pain in Individuals With COPD

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Dec 1, 2016
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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