Balneotherapy for Patients With Post-acute Coronavirus Disease (COVID) Syndrome

NCT05765591 | Completed

• 1 other identifier: 2021/10072/I
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-COVID-19 Syndrome

Keywords

Balneotherapy; Post-COVID-19 syndrome; Patient Reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

• 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: 1. Post-COVID-19 functional status scale (PCFS) 2. mMRC (Modified Medical Research Council) Dyspnoea Scale 3. Short Form-36 Health Survey (SF-36) 4. Pittsburgh Sleep Quality Index (PSQI) 5. Hospital Anxiety and Depression Scale (HADS) 6. Memory failures in everyday life following severe head injury (MFE-30) 7. 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 Outcomes (1)

• 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

  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)

Study Arms (2)

Balneotherapy group

EXPERIMENTAL

The patients allocated to the Balneotherapy group were subject to 3 weekly sessions of Balneotherapy together with an structured program of aquatic exercises on alternate days in groups of 8 during 4 weeks. The weekly planning was structured as following: 1. st day: Pool, shower, inhalation and aquatic exercises 2. nd day: Pool, shower, inhalation. 3. rd day: Pool, shower, inhalation and aquatic exercises

Other: Balneotherapy and aquatic exercises

Control group

NO INTERVENTION

Patients from the control group were instructed to not participate in any BT-related activity during the duration of the study and to continue with usual care and activities

Interventions

Balneotherapy and aquatic exercises OTHER

Information has already been included in arm/group descriptions

Balneotherapy group

Eligibility Criteria

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

You may qualify if:

• Individuals ≥18 years old with a post-acute COVID-19 syndrome diagnosis provided by a physician.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Caldes de Montbui's City Council: collaborator
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• European Regional Development Fund: collaborator

Study Sites (1)

Hospital del Mar Medical Research Institute

Barcelona, 08003, Spain

Location

Related Publications (1)

• Ovejero D, Ribes A, Villar-Garcia J, Trenchs-Rodriguez M, Lopez D, Nogues X, Guerri-Fernandez R, Garcia-Giralt N. Balneotherapy for the treatment of post-COVID syndrome: a randomized controlled trial. BMC Complement Med Ther. 2025 Feb 4;25(1):37. doi: 10.1186/s12906-025-04784-3.

  PMID: 39905419 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Balneology

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Translational Clinical Research Program Coordinator

Model Details: Randomized controlled longitudinal interventional study

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 13, 2023
• Study Start: March 29, 2022
• Primary Completion: October 29, 2022
• Study Completion: January 31, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)