Long COVID is defined by persistent symptoms after COVID-19 infection and includes symptoms of fatigue, breathlessness and reduced physical functioning. Research is needed to develop evidence-based guidelines for the management of long COVID. Pulmonary rehabilitation (PR) is the use of exercise, education, and behavioural intervention to improve physical functioning and quality of life in chronic lung diseases. Although recommended by experts, there is no evidence of the effect of PR in long COVID. We aim to study the effect of a 12-week PR programme in primary care, with supervision and coaching by primary care physiotherapists, compared to usual care on symptoms, physical functioning and physical activity in long COVID patients. 134 patients will be included in the interventional trial. The primary endpoint of the trial is change in exercise capacity measured by 6-minute walking distance, a valid and easy-to-use test. Other endpoints include symptoms questionnaires, daily physical activity, muscle strength, lung function, anxiety, depression and quality of life. Furthermore, we will study the cost-effectiveness of rehabilitation in long COVID.
| Summary of results |
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| Pulmonary rehabilitation (PR) is the use of exercise, education, and behavioral intervention to improve physical functioning and quality of life in chronic lung diseases, and improves physical status and symptoms in patients with long COVID, but access to specialised centres is challenging. This trial studied the effect of primary care PR on functional exercise capacity and symptoms in patients with long COVID. In this pragmatic RCT patients with long COVID were randomised to a 12-week stepwise PR program in primary care, or to a control group without PR. The primary endpoint was change in six-minute walk distance (6MWD) at twelve weeks. Additional outcomes, measured at 6, 12, 24 and 36 weeks, included patient-reported outcomes, physical activity, maximal inspiratory (MIP) and expiratory (MEP) pressures, and hand grip strength. In total, 76 patients were randomised [PR/control group (n=39/37); mean age 49±13years]. The improvement in 6MWD at twelve weeks was significantly higher in the PR group compared to the control group. Furthermore, a decrease in reported fatigue (as measured by the Checklist Individual Strength (CIS)-questionnaire) was found for the PR group. At 12 weeks, patients in the intervention group were more likely to have a clinically significant improvement in 6MWD, reported fatigue, MIP and dyspnoea score on the mMRC scale. In conclusion, we found that primary care stepwise PR improves functional exercise capacity, fatigue and dyspnoea in patients with long COVID. It should therefore be considered a viable treatment option in primary care for patients with long COVID with fatigue and/or respiratory symptoms. |
| Title | 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). |
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Participants (P) |
Individuals 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 >1 or CIS fatigue ≥36 or PCFS score of ≥2). |
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Intervention (I) |
Twelve weeks of primary care pulmonary rehabilitation (PR) including coaching by primary care physiotherapists. |
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Control (C) |
Control group consisting of usual care, which does not include a pulmonary rehabilitation program. |
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Outcome (O) |
Change in functional exercise capacity measured by 6-minute walking distance (6MWD) from baseline to 12 weeks. |
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Trial Design |
Prospective randomized, controlled, multicenter, pragmatic trial |
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Sample Size |
134 patients with Long COVID |
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Trial duration |
21 months |
| First Patient In | 1/12/2021 |
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Trial Report |
1/09/2023 |
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Budget |
650,000 € |
| Sponsor | Universitair Ziekenhuis Antwerpen (UZA) |
| Chief Investigator | Prof. Therese Lapperre (contact for study : ctc@uza.be) |
| Participating investigators | 2 (UZA and Ziekenhuis Oost-Limburg) and patients can be referred via primary care GP network and via advertisement |
| Protocol | Download protocol BMJ Open |
| Results | Download publication BMJ Open Respiratory Research |
For timelines and recruitment, see dashboard
Clinicaltrials.gov: NCT05244044
