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Recruiting
NCT05664945
Rethinking Pulmonary Rehabilitation
Conditions: Chronic Obstructive Pulmonary Disease
Sex: All
Ages: 40 Years – N/A
Phase: NA
Enrollment: 180
Sponsor: Copenhagen University Hospital, Hvidovre
Location: Denmark
Summary
Pulmonary rehabilitation (PR) is one of the cornerstones of care for people with COPD together with smoking cessation and medical treatment.
Despite the compelling evidence for its benefits, pulmonary rehabilitation is delivered to less than 30% of patients with COPD.
Access to PR are particularly challenging, and especially for those with the most progressed stages of the disease.Pulmonary Tele-rehabilitation (PTR) and Home-based pulmonary rehabilitation (HPR) are two emerging models using health-care supportive technology that have proven equivalent to the conventional PR programs in patients with COPD who are able and willing to participate in conventional PR.However, much remain unknown regarding patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation.
No studies have been conducted to specifically intervene towards this group.
Response from emerging rehabilitation models for this specific group is a black box with no substantial research.To fulfill its potential of relevance, results from emerging models, such as Pulmonary Telerehabilitation and Home-based pulmonary rehabilitation must be of clinical relevance, and superior to the current 'usual care' (medication and scheduled follow-up control) in patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation.
Eligibility Criteria
Inclusion Criteria:Indication for pulmonary rehabilitation according to Danish national guidelinesUnable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultationA post-bronchodilator ratio FEV1/FVC <70% (confirmed physician diagnosis of COPD)A post-bronchodilator FEV1 <80% (degree of airway obstruction) corresponding to GOLD grade 2-4 (moderate to very severe)GOLD group B, C, D corresponding to severe respiratory symptoms and/or frequent acute exacerbationsAble to stand up from a chair (height 44-46cm) and walk 10 meters independently (with or without a walking aid)Able to lift both arms to a horizontal level with a minimum of 1 kilogram's dumbbells in each handExclusion Criteria:Participation in conventional PR in the past 24 monthsCognitive impairment - unable to follow instructionsImpaired hearing or vision - unable to see or hear instruction from a tabletUnable to understand and speak DanishComorbidities where the exercise content is contraindicated (e.g.
treatment for diabetic foot ulcer, active cancer treatment, life expectancy <12-months)
Source: ClinicalTrials.gov (NCT05664945). StuddyBuddy aggregates publicly available trial information.