NCT07403305

Brief 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:
  • Lipid profile (cholesterol total, low-density lipoprotein cholesterol (c-LDL), high-density lipoprotein cholesterol (c-HDL), triglycerides)
  • Inflammatory biomarkers: interleukin-6 (IL-6), C-reactive protein (CRP)
  • Glucose metabolisc: fasting plasma glucose, insulin, Hemoglobin A1c (HbA1c)
  • Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, bilirubin, creatinine.
  • Anthropometric and clinical variables: weight, waist to hip ratio, body composition and bone mineral density
  • Systolic and diastolic blood pressure
  • Physical function
  • Lifestyle parameters: sleep quality, quality of life and eating habits

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

February 11, 2026

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

January 5, 2026

Last Update Submit

February 4, 2026

Conditions

Cardiovascular (CV) Risk

Keywords

Thermal WaterWater ExerciseHydropinotherapyLipid ProfileCardiovascular Health

Outcome Measures

Primary Outcomes (1)

  • Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)

    Change in total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglyceride concentrations (mg/dL), measured by enzymatic spectrophotometry, with LDL-C calculated.

    16 weeks

Secondary Outcomes (19)

  • Interleukin-6 (IL-6)

    16 weeks

  • C-reactive protein (CRP)

    16 weeks

  • Plasma Glucose

    16 weeks

  • Insulin

    16 weeks

  • Hemoglobin A1C (HbA1c)

    16 weeks

  • +14 more secondary outcomes

Study Arms (4)

Arm I: Control

NO INTERVENTION

Control

Arm II: WPEP in thermal water

OTHER

Water Physical Exercise Program in thermal water

Behavioral: WPEP in thermal water

Arm III: Hydropinotherapy

OTHER

Hydropinotherapy with thermal water combined with bay leaf (L. nobilis)

Other: Hydropinotherapy

Arm IV: WPEP in thermal water + Hydropinotherapy

OTHER

Water Physical Exercise Program in thermal water in thermal water and hydropinotherapy with thermal water combined with bay leaf (L. nobilis)

Behavioral: WPEP in thermal waterOther: Hydropinotherapy

Interventions

WPEP in thermal waterBEHAVIORAL

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 high-intensity interval training protocol with multi-joint exercises. The session will conclude with a 5-10-minute cool-down period. All sessions will be supervised and led by experienced exercise physiologists and physiotherapists to ensure participant safety and exercise efficacy.

Arm II: WPEP in thermal waterArm IV: WPEP in thermal water + Hydropinotherapy
HydropinotherapyOTHER

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 observed by the research team during ingestion to ensure compliance and safety. The thermal water used in this intervention is natural mineral water from Termas de Chaves, which emerges at a temperature of 77.0°C. It is classified as gasocarbonic, sodium bicarbonate, fluoride-based, and highly mineralized, with bicarbonate, chloride, sodium, and potassium as the predominant ions.

Arm III: HydropinotherapyArm IV: WPEP in thermal water + Hydropinotherapy

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women
  • Age: \>45 years
  • Written informed consent prior to participation
  • Physical condition suitable for participating in physical exercise activities
  • Controlled health conditions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Anna Carolina Cortez Ribeiro Research, PhD

CONTACT

+351938188980anna.cortez@ipb.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 11, 2026

Study Start

January 19, 2026

Primary Completion

May 22, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

February 11, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share