Menu
Not yet recruiting NCT07403305

The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovascular Health

No phase Interventional Cardiovascular (CV) Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WPEP in thermal water, Hydropinotherapy.
Who it may be relevant to
Registry conditions: Cardiovascular (CV) Risk. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Behavioral WPEP in thermal water
    Water Physical Exercise Program (WPEP) in thermal water The classes will take place in water maintained at 34°C. Training sessions will occur twice a week, with 50 minutes each and classes limited to 20 participants. Dumbbells and flotation devices will be used to increase exercise resistance, focusing on three main areas: upper body, lower body, and cardiorespiratory and abdominal exercises. Each session will begin with a 5-10-minute active warm-up period. The main workout will consist of a hi
  • Other Hydropinotherapy
    The hydropinotherapy intervention consists of the oral ingestion of thermal water combined with bay leaf (Laurus nobilis). Participants assigned to this intervention will ingest 200 mL of Chaves thermal water infused with dried bay leaf (L. nobilis) twice per week. The infusion will be prepared by the research team by adding 5 g of dried bay leaf (L. nobilis) to the thermal water and allowing it to infuse for 15 minutes, followed by filtration through a strainer. All participants will be observe

Primary outcome measures

  • Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides) [Time frame: 16 weeks]
Secondary outcome measures (12)
  • Interleukin-6 (IL-6) [Time frame: 16 weeks]
  • C-reactive protein (CRP) [Time frame: 16 weeks]
  • Plasma Glucose [Time frame: 16 weeks]
  • Insulin [Time frame: 16 weeks]
  • Hemoglobin A1C (HbA1c) [Time frame: 16 weeks]
  • Hepatic enzymes [Time frame: 16 weeks]
  • Bilirubin [Time frame: 16 weeks]
  • Blood pressure [Time frame: 16 weeks]
  • Waist and hip circumferences [Time frame: 16 weeks]
  • Body composition [Time frame: 16 weeks]
  • Bone mineral density [Time frame: 16 weeks]
  • Maximal oxygen uptake (VO₂ max) [Time frame: 16 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07403305 · IPBraganca · UIDB/00690/2020; UIDP/00690 · LA/P/0007/2020 · UIDB/00617/2020, LA/P/0064/202 · PRT/BD/154584/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗