No intervention, just observation
OtherNo Intervention, just observation
NCT Number: NCT04249388
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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Notify Me18 year and older
All sexes
Observational
Bispebjerg and Frederiksberg University Hospital, Copenhagen, Copenhagen North West, Denmark
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No Intervention, just observation
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in points. Lower score indicates improvement
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes i meters. High is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in point. Low score is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in Visual analogue scale (VAS). Higher VAS is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in points. Low is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
Observation of changes in points. Low is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in point. High is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in kilo. High is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in repetitions. High is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in point. Low score is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in actual numbers. Low is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in days. Low is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in actual number. Low is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
Observation of changes as number of deaths. Low is better
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in seconds. Low is better
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
University Hospital Bispebjerg and Frederiksberg
Other
Rethink Pulmonary Rehabilitation (REPORT Study)
Acronym: REPORT
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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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