The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovasc… (NCT07403305) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovascular Health
80 participantsStarted 2026-01-19
Plain-language summary
The goal of this randomized four-arm clinical trial is to determine the effect of 16-week water physical exercise program in thermal water and hydroponotherapy on lipide profile in middle-aged and elderly people, with controlled health conditions.
Participants will be randomizate into four arms:
* Arm I: Control
* Arm II: Water Physical Exercise Program (WPEP) in thermal water
* Arm III: Hydropinotherapy with thermal water combined with bay leaf (L. nobilis)
* Arm IV: WPEP in thermal water and hydropinotherapy with thermal water combined with bay leaf (L. nobilis)
Primary outcome:
1. Lipid profile (cholesterol total, low-density lipoprotein cholesterol (c-LDL), high-density lipoprotein cholesterol (c-HDL), triglycerides)
Secondary parameters:
2. Inflammatory biomarkers: interleukin-6 (IL-6), C-reactive protein (CRP)
3. Glucose metabolisc: fasting plasma glucose, insulin, Hemoglobin A1c (HbA1c)
4. Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, bilirubin, creatinine.
5. Anthropometric and clinical variables: weight, waist to hip ratio, body composition and bone mineral density
6. Systolic and diastolic blood pressure
7. Physical function
8. Lifestyle parameters: sleep quality, quality of life and eating habits
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women
* Age: \>45 years
* Written informed consent prior to participation
* Physical condition suitable for participating in physical exercise activities
* Controlled health conditions
Exclusion Criteria:
* History of chronic or severe diseases that may affect study outcomes or limit study participation, such as:
* Decompensated cardiovascular disease, renal insufficiency, or severe liver disease
* Conditions preventing the ability in physical activity (e.g., severe respiratory issues, reduced mobility, severe arthritis)
* Severe psychiatric or cognitive disorders that could affect comprehension or adherence to the study
* Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or corticosteroids
* Pregnancy or lactation
* Less than 80% attendance at the 16-week aquatic exercise program
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.