Status:
COMPLETED
Pulmonary Rehabilitation for Long COVID (Post COVID-19 Condition)
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Ziekenhuis Oost-Limburg
Universiteit Antwerpen
Conditions:
COVID-19
Long COVID
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In the PuRe COVID study (a randomized, controlled, multicenter, pragmatic trial) the investigators aim to assess the effect of a pulmonary rehabilitation program in primary care on exercise capacity (...
Eligibility Criteria
Inclusion
- Adult patients with status post COVID-19 (positive COVID-19 PCR or an official pharmacy performed antigen test or a self-performed test confirmed by a physician during the acute COVID-19 ≥ 6 weeks ago or positive antibodies before vaccination or positive antibodies before vaccination).
- Persistent COVID related symptoms that were not present pre-COVID-19 or were less severe pre-COVID.
- Symptomatic: quantified by dyspnea on exertion, loss of energy, fatigue or sleep impairment based upon the score of four questionnaires:
- COPD Assessment Test (CAT) ≥10, and/or
- modified Medical Research Council dyspnea scale (mMRC) ≥2, and/or
- CIS-fatigue ≥36, and/or
- post-COVID-19 Functional Status (PCFS) ≥2.
Exclusion
- Patients with known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that make it impossible to participate in pulmonary rehabilitation.
- Prior physiotherapy for long COVID if:
- patients who have completed ≥9 sessions of physiotherapy in total for long COVID.
- patients who completed any physiotherapy session in the previous 12 weeks for long COVID (primary care or hospital based; pulmonary or non-pulmonary).
- Patients with predominantly neurological disorders impacting respiratory function will not be eligible for the study.
- Patients that are not able to give informed consent or not able to complete questionnaires.
- Patients who have had any organ transplatation in the past, have to undergo any transplantation or are on an active transplantation list.
- Patients with active malignancy and/or (maintenance) treatment for active malignancy or curatively treated carcinoma within the past year.
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05244044
Start Date
April 19 2022
End Date
February 29 2024
Last Update
October 1 2024
Active Locations (2)
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1
UHAntwerp
Edegem, Antwerp, Belgium, 2650
2
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600