New approaches to pulmonary rehabilitation for COPD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of pulmonary tele-rehabilitation (PTR) and home-based pulmonary rehabilitation (HPR) for patients with Chronic Obstructive Pulmonary Disease (COPD) who cannot access traditional rehabilitation programs. It employs a three-arm randomized controlled trial design, comparing PTR and HPR against a control group receiving no intervention. The primary outcome is respiratory symptom relief measured by the CAT score, with secondary outcomes also assessed. The study aims to determine if these emerging rehabilitation models can provide significant benefits to a previously underserved patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Indication for pulmonary rehabilitation according to Danish national guidelines
* Unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation
* A 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 exacerbations
* Able 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 hand

Exclusion Criteria:

* Participation in conventional PR in the past 24 months
* Cognitive impairment - unable to follow instructions
* Impaired hearing or vision - unable to see or hear instruction from a tablet
* Unable to understand and speak Danish
* Comorbidities where the exercise content is contraindicated (e.g. treatment for diabetic foot ulcer, active cancer treatment, life expectancy \<12-months)

Where it's running

• Copenhagen University Hospital Amager
  Copenhagen, Greater Copenhagen, Denmark Recruiting
• Copenhagen University Hospital Bispebjerg-Frederiksberg
  Copenhagen, Greater Copenhagen, Denmark Recruiting
• Copenhagen University Hospital Herlve-Gentofte
  Gentofte, Greater Copenhagen, Denmark Recruiting
• Copenhagen University Hospital Nordsjaelland
  Hillerød, Greater Copenhagen, Denmark Recruiting
• Copenhagen University Hospital Hvidovre
  Hvidovre, Greater Copenhagen, Denmark Recruiting
• Municipality of Copenhagen
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Henrik Hansen, PhD — Dept. of Respiratory Medicine, University Hospital Hvidovre
• Study coordinator: Henrik Hansen, PhD
• Email: henrik.hansen.09@regionh.dk
• Phone: +4528946780

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.