NCT05244044Completed
Pulmonary Rehabilitation for Long COVID (Post COVID-19 Condition)
Changes in Functional Exercise Capacity After PUlmonary REhabilitation in Primary Care: a Randomized, Controlled, Multicenter, Pragmatic Trial in 134 Patients With Long COVID (PuRe-COVID)
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
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 (6MWT) and daily life physical activity in patients with long COVID. 134 patients with long COVID, defined by self-reported persistent COVID related symptoms ≥6 weeks after COVID-19 infection and a positive symptom score (CAT score ≥10 or mMRC score ≥2 or CIS-fatigue ≥36 or PCFS score of ≥2), will be recruited and divided into an intervention group or a control group. The intervention group will get twelve weeks of primary care pulmonary rehabilitation (PR) including coaching by primary care physiotherapists. The control group consists of usual care, which does not include a pulmonary rehabilitation program. This study will help determine whether the type of symptoms or affected body system can impact recovery form long covid during rehabilitation and after follow-up. The investigators will analyze determinants and risk factors that characterize non-responders and non-adherers to better understand which patients with long COVID benefit from rehabilitation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 14 Feb 2022
- Start date
- 19 Apr 2022
- Primary completion date
- 18 Dec 2023
- Lead sponsor
- University Hospital, Antwerp
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05244044
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 19 Apr 2022 to the primary completion date, 18 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who have had any organ transplatation in the past, have to undergo any transplantation or are on an active transplantation list.
Other illness
- Patients with known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that make it impossible to participate in pulmonary rehabilitation.
- Patients with predominantly neurological disorders impacting respiratory function will not be eligible for the study.
- Patients with active malignancy and/or (maintenance) treatment for active malignancy or curatively treated carcinoma within the past year.
Other
- Patients that are not able to give informed consent or not able to complete questionnaires.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UHAntwerp Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
Related publications
- Improved functional exercise capacity after primary care pulmonary rehabilitation in patients with long COVID (PuRe-COVID): a pragmatic randomised controlled trial.BMJ Open Respir Res · 2025 · PMID 41253410
This page is information, not medical advice. Discuss any trial with your doctor.