Evaluation of the Effectiveness of a Spa Treatment for People With Post-Covid 19 Conditions.
NCT Number: NCT06570239
Acronym: COVIDTHERM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post COVID-19 Condition
Interventions: PROCEDURE: intervention group
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2026-10-01

Summary:
Following the acute phase of Covid-19, some patients experience persistent or recurrent symptoms. These symptoms can take a number of forms: intense fatigue, cognitive dysfunction, respiratory difficulties, maladaptation to physical exertion, musculoskeletal pain, anxiety-depressive disorders, malnutrition, loss of sense of smell, headaches and so on. These symptoms are known as post-covid-19 disease, defined by the WHO as "a condition occurring in people with a history of probable or confirmed infection with SARS-CoV-2, usually 3 months after the onset of COVID-19 with symptoms that persist for at least 2 months and cannot be explained by another diagnosis. Common symptoms include fatigue, breathlessness and cognitive dysfunction, as well as other symptoms that generally have an impact on daily functioning.

The aim of this interventional research project is to assess the place of a specific spa treatment for people with a post-Covid 19 condition in the primary care pathway.

Primary Outcome Measures: Primary Outcome, The primary endpoint of this study was the change in the utility score derived from the measured by the EQ-5D-5L at 2 months (V2-V0) after inclusion., at the 2-month visit (V2)
Secondary Outcome Measures: Utility score (EQ-5D-5L), Variation in the mean utility score (EQ-5D-5L) calculated in each management group (protocol A and protocol B) between V0 and V2, V3 and V4 (including Vend),, Utility score (EQ-5D-5L) measured at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)|Number of symptoms and symptoms clusters, Variation in the following parameters: number of symptoms and symptoms clusters, scoring by symptom scales and tests (Appendices), asthenia (Chalder fatigue scale ), sleep disorders (Insomnia Severity Index́ (ISI) ), pain (visual analogue pain scale ), anxiety-depression (HAD scale ), post-traumatic stress (PCL-5 scale ), dyspnoea (mMRC - modified Medical Research Council scale) and modified Borg scale , muscle strength in the limbs (standing-sitting test ), balance tests (FUKUDA test, get up and go test), postural balance on a posturography platform, with sensitisation by modification of somato-sensory afferents (foam tray) and visual afferents (goggles virtual realitý goggles),, Utility score (EQ-5D-5L) measured at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)|Return to work, Data on return to work (time taken to return to work part-time and full-time, modified post, etc.),, Employment status requested at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)|Medical consultations, Number of medical consultations, physiotherapy, psychology and other paramedical psychology and other paramedical care, analgesics, anxiolytics, anti-depressants, systemic or inhaled corticosteroids, bronchodilators and antihistamines not included in the protocol, Number of medical consultations at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)