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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05765591
Other study ID # 2021/10072/I
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2022
Est. completion date January 31, 2023

Study information

Verified date March 2023
Source Parc de Salut Mar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Balneotherapy and aquatic exercises
Information has already been included in arm/group descriptions

Locations

Country Name City State
Spain Hospital del Mar Medical Research Institute Barcelona

Sponsors (4)

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

Country where clinical trial is conducted

Spain, 

Outcome

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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