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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular (CV) Risk
• Intervention / Treatment: Behavioral: WPEP in thermal water; Other: Hydropinotherapy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Carolina Cortez Ribeiro Research, PhD; Phone Number: +351938188980; Email: anna.cortez@ipb.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm I: Control; Control
Other: Arm II: WPEP in thermal water; Water Physical Exercise Program in thermal water	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 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.
Other: Arm III: Hydropinotherapy; Hydropinotherapy with thermal water combined with bay leaf (L. nobilis)	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 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.
Other: Arm IV: WPEP in thermal water + Hydropinotherapy; 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 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 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.; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-6 (IL-6)	Change in serum interleukin-6 (IL-6) concentration (pg/mL), measured by enzyme-linked immunosorbent assay (ELISA)	16 weeks
C-reactive protein (CRP)	Change in serum C-reactive protein concentration (mg/L) measured by chemiluminescent microparticle immunoassay (CMIA).	16 weeks
Plasma Glucose	Change in fasting plasma glucose concentration (mg/dL), measured using standard laboratory methods.	16 weeks
Insulin	Change in fasting serum insulin concentration (µIU/mL), measured using standard laboratory methods.	16 weeks
Hemoglobin A1C (HbA1c)	Change in glycated hemoglobin (HbA1c, %), measured using standard laboratory methods.	16 weeks
Hepatic enzymes	Change in serum aspartate transaminase (AST) activity (U/L), alanine transaminase (ALT) activity (U/L), measured by enzymatic spectrophotometry.	16 weeks
Bilirubin	Change in total bilirubin concentration (mg/dL), measured by enzymatic spectrophotometry.	16 weeks
Blood pressure	Change in systolic and diastolic blood pressure (mmHg), measured using a digital blood pressure monitor following a standardized seated protocol, with the average of two readings recorded.	16 weeks
Waist and hip circumferences	Change in waist circumference (cm) and hip circumference (cm), measured using a non-elastic measuring tape according to ISAK protocols.	16 weeks
Body composition	Change in total fat mass (kg), truncal fat mass (kg), abdominal fat mass (kg), lean body mass (kg), assessed by dual-energy X-ray absorptiometry (DXA).	16 weeks
Bone mineral density	Change in bone mineral density (g/cm²) from baseline to 16 weeks, assessed by dual-energy X-ray absorptiometry (DXA).	16 weeks
Maximal oxygen uptake (VO₂ max)	Change in maximal oxygen uptake (mL/kg/min), assessed using a graded treadmill exercise test to volitional exhaustion.	16 weeks
Isokinetic muscle strength	Change in peak torque (Nm) of knee flexors and extensors, hip flexors/extensors and abductors/adductors, and ankle dorsiflexors and plantarflexors, assessed using isokinetic dynamometry.	16 weeks
Sleep quality	Change in sleep quality score, assessed by the Pittsburgh Sleep Quality Index (PSQI; score range 0-21, higher scores indicate worse sleep quality).	16 weeks
Health-related quality of life	Change in health-related quality of life score from baseline to 16 weeks, assessed by the Short Form-36 Health Survey (SF-36; score range 0-100, higher scores indicate better health status).	16 weeks
Pain intensity	Change in pain intensity score from baseline to 16 weeks, assessed by the Numeric Rating Scale (NRS; score range 0-10, higher scores indicate worse pain).	16 weeks
Psychosocial risk factors	Change in psychosocial risk classification from baseline to 16 weeks, assessed by the Start Back Screening Tool (SBST; score range 0-9, higher scores indicate higher psychosocial risk).	16 weeks
Total energy intake	Change in total energy intake (kcal/day), assessed using a 24-hour dietary recall administered by a trained nutritionist.	16 weeks
Macronutrient intake	Change in macronutrient intake (g/day: proteins, total fats, carbohydrates, fiber), assessed using a 24-hour dietary recall administered by a trained nutritionist.	16 weeks

Collaborators and Investigators

• Sponsor: Instituto Politécnico de Bragança
• Collaborators: Universidade do Porto; Universidade Federal do Paraná

Study record dates

Study Major Dates

• Study Start (Estimated): January 19, 2026
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular Health; Lipid Profile; Water Exercise; Thermal Water; Hydropinotherapy
• Other Study ID Numbers: IPBraganca; UIDB/00690/2020; UIDP/00690 (Other Grant/Funding Number: Fundação para Ciência e Tecnologia); LA/P/0007/2020 (Other Grant/Funding Number: Fundação para Ciência e Tecnologia); UIDB/00617/2020, LA/P/0064/202 (Other Grant/Funding Number: Fundação para Ciência e Tecnologia (FCT)); PRT/BD/154584/2023 (Other Grant/Funding Number: Fundação para Ciência e Tecnologia (FCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No