Efficacy of Spa Management (Hydrokinesitherapy and Crenobalneotherapy) Compared With Usual Management of People With Post-Covid-19 Conditions: a Randomized, Open-label Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Primary Outcome
研究概览
简要总结
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.
详细描述
Justification/context
Most of the studies initially published involved cohorts of patients hospitalized during the initial phase. The French Covid-19 cohort, which studied 1137 patients after hospitalization for SARS-CoV-2 infection, showed that 60% complained of at least one symptom still present at 6 months, 24% three or more persistent symptoms, and that 29% of those with a professional activity had not returned to work (1). At 12 months, 34% of women and 23% of men were still on sick leave (2). The susceptibility of adults seems to increase with age, number of symptoms in the acute phase, body mass index, female sex and absence of vaccination (3). The evolution of post-covid disease fluctuates over time (4).
Studies of cohorts of patients followed up in primary care show that post-covid affliction affects people with both severe and mild forms of the disease. As part of the virtual ambulatory follow-up program (CoviCare), 410 people testing positive for COVID-19 at Geneva University Hospital were followed up 7 to 9 months after diagnosis: 39.0% reported residual symptoms. Analysis of a prospective cohort of 247 Norwegian patients followed at home showed that 52% of young adults aged 16 to 30 had symptoms at 6 months, including loss of taste and/or smell (28%), fatigue (21%), dyspnea (13%), impaired concentration (13%) and memory impairment (11) A literature review of quality of life in post-covid conditions conducted between March 2020 and March 2021 (12 studies involving 4828 patients) showed that the combined prevalence of poor quality of life (EQ-VAS) was estimated at 59%. Meta-regression analysis showed that poor quality of life was significantly higher in patients with ICU admission and fatigue. At 2 months, an alteration in quality of life defined by a 10-point difference on the EQ-5D-5L analog scale was noted in 44% of hospitalized patients. The study by Logues et al, involving 177 patients in the United States, showed that 30% of outpatients had an altered quality of life at 9 months, defined as a 10-point decrease in the EQ-VAS compared with the previous situation, versus 2% of non-infected control subjects. Menges et al studied quality of life using the EQ-5D-5L scale in 431 patients in Zurich, 89% of whom were non-hospitalized. They showed that 53% of participants reported difficulties in at least one dimension of the EQ-5D-5L. The dimensions most frequently affected were pain/discomfort (39%) and anxiety/depression (31%).
Primary objective:
To compare the efficacy of a spa-based rehabilitation and support protocol (Protocol B) versus a conventional primary care rehabilitation and support protocol (Protocol A) on changes in overall quality of life at 2 months in patients suffering from post-Covid-19 symptoms who did not warrant́ hospitalization for treatment of the initial phase of Covid
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Primary Outcome
时间窗: at the 2-month visit (V2)
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.
次要结局
- Medical consultations(Number of medical consultations 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))
- 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))
研究者
KANNY Gisele
Professor
Central Hospital, Nancy, France