Post-COVID-19 Syndrome Clinical Trial
Official title:
Effects of Balneotherapy for Patients With Post-COVID Syndrome
Verified date | March 2023 |
Source | Parc de Salut Mar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this randomized controlled study is to evaluate the effects of balneotherapy (BT) and aquatic exercises in patients with post-acute COVID syndrome (PACS). The main question it aims to answer are: • Does BT and aquatic exercises alleviate some of the most prevalent features that characterize post-acute COVID syndrome? Participants allocated to the intervention group will undergo 3 weekly sessions of BT and aquatic exercises on alternate days in groups of 8 during 4 weeks. Prior the beginning of the intervention, patients were asked to complete an array of validated self-reported questionnaires that covered an important part of PACS symptomatology. These patients were asked to complete these same questionnaires immediately after completing the intervention and one month after. They were also asked to report adverse events associated to the intervention. Patients allocated to the control group were asked to complete the same questionnaires at baseline and one and two months post-baseline. They were instructed to not enroll in any kind of BT-related activities during the duration of the study. Questionnaires were analyzed and compared between groups to assess the effects of the intervention.
Status | Completed |
Enrollment | 98 |
Est. completion date | January 31, 2023 |
Est. primary completion date | October 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Individuals =18 years old with a post-acute COVID-19 syndrome diagnosis provided by a physician. Exclusion Criteria: - Patients with preexisting disorders to the acute SARS-CoV-2 infection that displayed an important clinical overlap with PACS i.e., fibromyalgia (FM), chronic fatigue syndrome, chronic pain, and generalized anxiety disorder and/or depression that required pharmacological treatment. Patients with chronic debilitating conditions that required active treatment were also excluded i.e. cancer, chronic viral infections, systemic autoimmune diseases, epilepsy, uncontrolled endocrine disorders, etc. Patients with fear of water, incontinence, severe venous insufficiency, physical disabilities that hindered performance of balneotherapy/aquatic exercises, and those who reported a tendency for symptomatic low blood pressure were also excluded. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar Medical Research Institute | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar | Caldes de Montbui's City Council, Consorcio Centro de Investigación Biomédica en Red (CIBER), European Regional Development Fund |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in questionnaire scores in follow-up time points compared to baseline between both groups | To evaluate the effects of BT we employed an array of validated self-reported questionnaires that covered an important part of PACS symptomatology. The primary outcome of the study was to evaluate differences in questionnaire scores from baseline between both groups. The following scales and questionnaires were employed:
Post-COVID-19 functional status scale (PCFS) mMRC (Modified Medical Research Council) Dyspnoea Scale Short Form-36 Health Survey (SF-36) Pittsburgh Sleep Quality Index (PSQI) Hospital Anxiety and Depression Scale (HADS) Memory failures in everyday life following severe head injury (MFE-30) Visual Analogic Scale (VAS) |
2 months i.e., baseline, post-balneotherapy (or one month post-baseline in the control group), and 1 month post-balneotherapy (or 2 months post-baseline in the control group) | |
Secondary | Differences in the percentage of individuals within each group that showed any improvement in the questionnaires' scores at follow-up time-points compared to baseline | Differences in the percentage of individuals within each group that showed any improvement in the questionnaires' scores at follow-up time-points compared to baseline. The following scales and questionnaires were employed:
Post-COVID-19 functional status scale (PCFS) mMRC (Modified Medical Research Council) Dyspnoea Scale Short Form-36 Health Survey (SF-36) Pittsburgh Sleep Quality Index (PSQI) Hospital Anxiety and Depression Scale (HADS) Memory failures in everyday life following severe head injury (MFE-30) Visual Analogic Scale (VAS) |
2 months i.e., baseline, post-balneotherapy (or one month post-baseline in the control group), and 1 month post-balneotherapy (or 2 months post-baseline in the control group) |
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