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

NCT06570239 | Not Yet Recruiting

• 2 other identifiers: 2021PI1652023-A01261-44
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post COVID-19 Condition

Outcome Measures

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.

  at the 2-month visit (V2)

Secondary Outcomes (4)

• Utility score (EQ-5D-5L)

  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

  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

  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 at the 2-month visit (V2), the six-month visit (V3) and the 12-month visit (V4)

Study Arms (2)

Protocol A: Control group

ACTIVE COMPARATOR

Protocol A combines dry physiotherapy with psychological support. psychological support.

Procedure: intervention group

Protocol B: Intervention group

EXPERIMENTAL

Protocol B combines hydrokinesitherapy and hydrothermal treatments, psychological psychological support.

Procedure: intervention group

Interventions

intervention group PROCEDURE

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.

Protocol A: Control group; Protocol B: Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Officials

• Giséle KANNY, PU-PH

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

• Julie DALCOURT, PH

  Centre Hospitalier Ouest Vosgien CHOV

  PRINCIPAL INVESTIGATOR

• Simon RUDYNSKI, Dr

  Centre Thermal Saint Eloy-Amnéville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfousseyni COLY

CONTACT

0383852985; a.coly@chru-nancy.fr

Giséle KANNY, PU-PH

CONTACT

0383154143; g.kanny@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a regional multicentre randomised controlled open-label study. Control arm : dry support and rehabilitation protocol for 3 weeks Intervention arm: support and rehabilitation protocol in natural mineral water for for 3 weeks.

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08