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Completed

NCT Number: NCT04249388

Characteristics of People With Advanced Chronic Obstructive Pulmonary Disease (COPD) - A Multicenter Study

Pulmonary rehabilitation (PR) is a cornerstone of care for people with COPD. There is robust evidence that PR improves exercise capacity, enhances health-related quality of life (QoL) and reduces healthcare utilization. PR is strongly recommended in guidelines for COPD management. Despite the compelling evidence for its benefits, PR is delivered to less than 30% of people with COPD. Access is particularly challenging, an especially for those with the most progressed disease stages.

We recently completed a randomized clinical trial, showing that approximately 1.100 patients annually are offered conventional hospital-based PR during routine consultations in the Capital Region of Denmark, but at least 700 patients declines participation.

No major cohort studies have been published from people with severe and advanced COPD who opt out of traditional pulmonary rehabilitation. By establishing such cohort study, objective and qualitative knowledge from assessments and patient interviews is collected in patients we have very limited access to and knowledge of. Additionally, the collected data will give a deeper insight and understanding and possibly enable us to design new delivery models to be tested in proper study designs.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg and Frederiksberg University Hospital, Copenhagen, Copenhagen North West, Denmark

Loading trial locations.

About this study

Objective This cohort study aims to describe and understand differences and similarities in characteristics among people with severe and advanced COPD who opt-in or opt out of PR services.

The study includes data from: socio-demographic, anthropometric, physical (function, activity, muscle strength, balance) characteristics as well as self-reported symptoms of anxiety, depression, fatigue, pain, lung symptoms, quality of life, sleep-quality, mortality, hospitaladmissions, length of stay and qualitative patient interviews.

Data from our completed trial study (NCT02667171) will be used as the opt-in PR comparison cohort.

Who can participate

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

Inclusion criteria

  • Clinical diagnosis of COPD defined as a ratio of forced expiratory volume at one second (FEV1) to forced vital capacity < 0.70
  • FEV1 <50%, corresponding to severe or very severe COPD
  • Symptoms equivalent to the Medical Research Council (MRC) from 2 to 5
  • Declines to participate in a conventional out-patient hospital-based PR program

Exclusion criteria

  • Concurrent participation in or recent completion of pulmonary rehabilitation within the last twelve months.
  • Dementia/ Cognitive impairment or uncontrolled psychiatric illness,
  • An impaired hearing and / or vision which causes the instructions in the assessment is not understood.
  • language difficulties which causes inability to follow instruction or complete patient reported outcome measures (PROM.)
  • Any comorbidity that are contraindicated to the assesment protocol.

Treatment and study plan

No intervention, just observation

Other

No Intervention, just observation

Primary outcomes

  1. COPD Assessment Test (CAT)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in points. Lower score indicates improvement

Secondary outcomes

  1. 6-Minute Walk Test Distance (6MWD)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes i meters. High is better

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in point. Low score is better

  3. Euro-Qol (EQ5D)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in Visual analogue scale (VAS). Higher VAS is better

  4. Brief Pain Inventory (BPI)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in points. Low is better

  5. Multidimensional Fatigue Inventory (MFI-20)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)

    Observation of changes in points. Low is better

  6. Short Physical Performance Battery (SPPB)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in point. High is better

  7. Hand-Grip Strength (JAMAR)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in kilo. High is better

  8. 30 seconds sit-to-stand test (30sec-STS)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in repetitions. High is better

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in point. Low score is better

  10. Number of hospital admissions (respiratory and all-cause)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in actual numbers. Low is better

  11. Length of hospital admissions (respiratory and all-cause)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in days. Low is better

  12. Out-patient visits

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in actual number. Low is better

  13. Mortality (respiratory and all-cause)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)

    Observation of changes as number of deaths. Low is better

  14. Timed Up and Go Test

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

    Observation of changes in seconds. Low is better

  15. Activity level (ActivPAL)

    Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) - Worn by the patients around the clock for 5 days

    Observation of changes in steps per day. High is better

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Collaborators

  • Herlev and Gentofte Hospital
  • Hillerod Hospital, Denmark

Registry information

Official study title

Rethink Pulmonary Rehabilitation (REPORT Study)

Acronym: REPORT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2020
Registry last updated
May 10, 2023

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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