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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • intervention group

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Protocol A: Control groupActive comparator 1 intervention
Group B: Protocol B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at the 2-month visit (V2)

Secondary outcomes

1

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),

Time frame
Utility score (EQ-5D-5L) measured at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)
2

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),

Time frame
Utility score (EQ-5D-5L) measured at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)
3

Return to work

Data on return to work (time taken to return to work part-time and full-time, modified post, etc.),

Time frame
Employment status requested at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)
4

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

Time frame
Number of medical consultations at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: