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NCT06570239

Evaluation of the Effectiveness of a Spa Treatment for People With Post-Covid 19 Conditions.

Sponsor: Central Hospital, Nancy, France

View on ClinicalTrials.gov

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.

Official title: Efficacy of Spa Management (Hydrokinesitherapy and Crenobalneotherapy) Compared With Usual Management of People With Post-Covid-19 Conditions: a Randomized, Open-label Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-10-01

Completion Date

2026-10-01

Last Updated

2024-08-26

Healthy Volunteers

Conditions

Post COVID-19 Condition

Interventions

PROCEDURE

intervention group

Protocol A combines dry physiotherapy and psychological support. It will be organised on an outpatient basis. Weeks 1, 2 and 3: 8 sessions of "dry" physiotherapy and 3 sessions of psychotherapy. 5 psychotherapy sessions will be given over the following five weeks. Protocol B combines hydro-physiotherapy and hydro-thermal treatments with psychological support. Protocol B begins with 3 weeks in a spa establishment - Care provided during weeks 1, 2 and 3: 8 hydrokinesitherapy sessions, 32 hydrothermal treatments, 3 psychotherapy sessions. 5 psychology sessions will be given over the following five weeks.

Inclusion Criteria: * Person who has received full information about the organisation of the research, who has not * to their participation and the use of their data, and who have given their free and free and informed consent in writing, * Patients aged 18 and over, * Patients with a history of symptomatic Covid-19 infection documented by RTPCR, antigenic test, positive serology in a patient not previously vaccinated or other virological diagnostic test validated at the patient's inclusion date, * A person who has not required hospitalisation for treatment in the initial phase of Covid-19, * Person presenting at least two common symptoms of the post-Covid condition from among fatigue, breathlessness, cognitive dysfunction, appearing de novo and evolving for more than for more than 12 weeks and present for more than 8 weeks, * Initial and prolonged symptoms not explained by another diagnosis with no known link to with Covid-19, * Normal SpO2 at rest not decreasing beyond 4% on exercise, * Membership of a social security scheme or beneficiary of such a scheme. Exclusion Criteria: * Acute cardiovascular disease (acute coronary syndrome, arrhythmia, heart failure, venous thromboembolism venous thromboembolic disease, myocarditis, stroke, acute ischaemia, etc.) less than stroke, acute ischaemia, etc.) less than 3 months old and at risk of recurrence or decompensation, * Respiratory disease: COPD, interstitial fibrosis, exercise-induced desaturation, sleep apnoea * Stroke less than 6 months old, * Pregnant women, * Adults subject to a legal protection measure (guardianship, curatorship, safeguard of justice), * Serious and unstable psychiatric pathology, severe depressive syndrome, delirious decompensation, panic attacks, anxiety-depression syndrome, * Acute and progressive conditions (infectious, cancerous and inflammatory), * Person with a contraindication to hydrokinesitherapy and crenotherapy crenotherapy (infected dermatoses, severe immune deficiencies, inflammatory diseases, faecal or urinary incontinence, presence of a suprapubic or intravenous catheter, colostomy, hydrophobia) * Refusal to sign the free and informed consent form