Multimodal web-based telerehabilitation for patients with post COVID-19 condition (Mainz PCC TeR Study): Study protocol of a randomized controlled clinical trial (Preprint)

Abstract

Patients affected by post COVID-19 condition have long-term and health-related consequences of severe acute respiratory syndrome coronavirus-2, manifesting as persistent fatigue, dyspnea/hyperventilation, limitations in daily activities, cognitive impairment and mental disorders. Consequences exceed individual health, impacting social systems and the economy. Existing evidence indicates that exercise and respiratory therapy based telerehabilitation has the potential to improve cardiorespiratory fitness and hyperventilation and reduce care costs.

The primary objective of this randomized, controlled clinical trial is to investigate the superiority of our multimodal, web-based telerehabilitation program compared to treatment as usual in terms of cardiorespiratory fitness (VO2peak [ml/min/kg]) and hyperventilation (VE/VCO2 slope [full-slope]) in severely affected post COVID-19 patients. In addition, the clinical and exercise physiological processes associated with the post COVID-19 condition will be investigated.

We designed a waiting list randomized controlled clinical trial with three examination time points and two study phases. Following baseline assessment, patients will be randomly allocated to either the intervention group (IG) or the control group (CG). During the intervention phase (8 weeks), all IG participants receive web-based multimodal and symptom-titrated telerehabilitation program that includes weekly teleconsultations, a pacing approach, exercise and respiratory therapy, while the CG receives treatment as usual (sports medicine consultation about healthy habits and the pacing approach: self-directed management of symptoms and activities). After the primary assessment in the follow-up phase (8 weeks), the IG continued their training but without teleconsultation self-directed, while the CG received the same intervention as the IG followed by follow-up assessment.

Recruitment started in August 2023. It is estimated that the recruitment period will be 12 months. Data collection is planned to be completed in 2024.

This study is the first randomized controlled clinical trial investigating the effects of a multimodal and symptom-titrated TeR in severely affected PCC patients. The integration of various objective diagnostic systems to analyze clinical and exercise physiological processes associated with post COVID-19 condition will provide valuable insights into emerging postviral fatigue syndrome.

https://drks.de/search/de/trial/DRKS00032394. Registered 28 July 2023 prospectively registered in the German Clinical Trials Register (DRKS).