Cardiovascular (CV) RiskWPEPHNCT07403305
The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovascular Health
A study testing WPEP in thermal water and Hydropinotherapy in people with Cardiovascular (CV) Risk, run by Instituto Politécnico de Bragança.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular (CV) Risk
- What is being tested?
- WPEP in thermal water and Hydropinotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women
- Age: >45 years
- Written informed consent prior to participation
- Physical condition suitable for participating in physical exercise activities
- Controlled health conditions
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- 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) Secondary parameters:
- 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
- Conditions
- Cardiovascular (CV) Risk
- Being tested
- WPEP in thermal water, Hydropinotherapy
- Keywords
- Thermal Water, Water Exercise, Hydropinotherapy, Lipid Profile, Cardiovascular Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WPEP in thermal waterBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Control | No intervention | Control |
| Arm II: WPEP in thermal water | Other | Water Physical Exercise Program in thermal water Receives: Behavioral: WPEP in thermal water |
| Arm III: Hydropinotherapy | Other | Hydropinotherapy with thermal water combined with bay leaf (L. nobilis) Receives: 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) Receives: Behavioral: WPEP in thermal water; Other: Hydropinotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (19)
Interleukin-6 (IL-6)
Change in serum interleukin-6 (IL-6) concentration (pg/mL), measured by enzyme-linked immunosorbent assay (ELISA)
Measured: 16 weeks
C-reactive protein (CRP)
Change in serum C-reactive protein concentration (mg/L) measured by chemiluminescent microparticle immunoassay (CMIA).
Measured: 16 weeks
Plasma Glucose
Change in fasting plasma glucose concentration (mg/dL), measured using standard laboratory methods.
Measured: 16 weeks
Insulin
Change in fasting serum insulin concentration (µIU/mL), measured using standard laboratory methods.
Measured: 16 weeks
Hemoglobin A1C (HbA1c)
Change in glycated hemoglobin (HbA1c, %), measured using standard laboratory methods.
Measured: 16 weeks
Hepatic enzymes
Change in serum aspartate transaminase (AST) activity (U/L), alanine transaminase (ALT) activity (U/L), measured by enzymatic spectrophotometry.
Measured: 16 weeks
Bilirubin
Change in total bilirubin concentration (mg/dL), measured by enzymatic spectrophotometry.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 16 weeks
Total energy intake
Change in total energy intake (kcal/day), assessed using a 24-hour dietary recall administered by a trained nutritionist.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start19 Jan 2026 (estimated)
- Primary completion22 May 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular (CV) RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Bragança
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto, Universidade Federal do Paraná
- Responsible party
- Principal investigator, Anna Carolina Cortez Ribeiro, Instituto Politécnico de Bragança
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403305
- Sponsor's protocol ID
- IPBraganca
- Other IDs
- UIDB/00690/2020; UIDP/00690, LA/P/0007/2020, UIDB/00617/2020, LA/P/0064/202, PRT/BD/154584/2023
- Acronym
- WPEPH
- Status last verified
- Nov 2025
- First submitted
- 5 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT07403305
- Acronym / sponsor ID
- WPEPH / IPBraganca
- Conditions
- Cardiovascular (CV) Risk
- Keywords
- Thermal Water, Water Exercise, Hydropinotherapy, Lipid Profile, Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto Politécnico de BragançaUniversity, hospital or other
- Collaborators
- Universidade do Porto, Universidade Federal do Paraná
- Study start
- 19 Jan 2026 (estimated)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) Secondary parameters:
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I: Control | No intervention | –Control |
| Arm II: WPEP in thermal water | Other | Behavioral: WPEP in thermal waterWater Physical Exercise Program in thermal water |
| Arm III: Hydropinotherapy | Other | Other: HydropinotherapyHydropinotherapy with thermal water combined with bay leaf (L. nobilis) |
| Arm IV: WPEP in thermal water + Hydropinotherapy | Other | Behavioral: WPEP in thermal water, Other: HydropinotherapyWater Physical Exercise Program in thermal water in thermal water and hydropinotherapy with thermal water combined with bay leaf (L. nobilis) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women
- Age: >45 years
- Written informed consent prior to participation
- Physical condition suitable for participating in physical exercise activities
- Controlled health conditions
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WPEP in thermal waterWater 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. | Behavioural | Arm II: WPEP in thermal water, Arm IV: WPEP in thermal water + Hydropinotherapy |
| HydropinotherapyThe 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 III: Hydropinotherapy, Arm IV: WPEP in thermal water + Hydropinotherapy |
Primary outcome
Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)
Time frame: 16 weeks
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.
19 secondary outcomes
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
Isokinetic muscle strength
Time frame: 16 weeks
Sleep quality
Time frame: 16 weeks
Health-related quality of life
Time frame: 16 weeks
Pain intensity
Time frame: 16 weeks
Psychosocial risk factors
Time frame: 16 weeks
Total energy intake
Time frame: 16 weeks
Macronutrient intake
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing WPEP in thermal water and Hydropinotherapy in people with Cardiovascular (CV) Risk, run by Instituto Politécnico de Bragança.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Carolina Cortez Ribeiro Research, PhD (+351938188980, anna.cortez@ipb.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.