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NCT Number: NCT07403305

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

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

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Key information

Conditions

Cardiovascular (CV) Risk

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WPEP in thermal water

Behavioral

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.

Hydropinotherapy

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Interleukin-6 (IL-6)

    Time frame: 16 weeks

    Change in serum interleukin-6 (IL-6) concentration (pg/mL), measured by enzyme-linked immunosorbent assay (ELISA)

  2. C-reactive protein (CRP)

    Time frame: 16 weeks

    Change in serum C-reactive protein concentration (mg/L) measured by chemiluminescent microparticle immunoassay (CMIA).

  3. Plasma Glucose

    Time frame: 16 weeks

    Change in fasting plasma glucose concentration (mg/dL), measured using standard laboratory methods.

  4. Insulin

    Time frame: 16 weeks

    Change in fasting serum insulin concentration (µIU/mL), measured using standard laboratory methods.

  5. Hemoglobin A1C (HbA1c)

    Time frame: 16 weeks

    Change in glycated hemoglobin (HbA1c, %), measured using standard laboratory methods.

  6. Hepatic enzymes

    Time frame: 16 weeks

    Change in serum aspartate transaminase (AST) activity (U/L), alanine transaminase (ALT) activity (U/L), measured by enzymatic spectrophotometry.

  7. Bilirubin

    Time frame: 16 weeks

    Change in total bilirubin concentration (mg/dL), measured by enzymatic spectrophotometry.

  8. Blood pressure

    Time frame: 16 weeks

    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.

  9. Waist and hip circumferences

    Time frame: 16 weeks

    Change in waist circumference (cm) and hip circumference (cm), measured using a non-elastic measuring tape according to ISAK protocols.

  10. Body composition

    Time frame: 16 weeks

    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).

  11. Bone mineral density

    Time frame: 16 weeks

    Change in bone mineral density (g/cm²) from baseline to 16 weeks, assessed by dual-energy X-ray absorptiometry (DXA).

  12. Maximal oxygen uptake (VO₂ max)

    Time frame: 16 weeks

    Change in maximal oxygen uptake (mL/kg/min), assessed using a graded treadmill exercise test to volitional exhaustion.

  13. Isokinetic muscle strength

    Time frame: 16 weeks

    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.

  14. Sleep quality

    Time frame: 16 weeks

    Change in sleep quality score, assessed by the Pittsburgh Sleep Quality Index (PSQI; score range 0-21, higher scores indicate worse sleep quality).

  15. Health-related quality of life

    Time frame: 16 weeks

    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. Pain intensity

    Time frame: 16 weeks

    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).

  17. Psychosocial risk factors

    Time frame: 16 weeks

    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).

  18. Total energy intake

    Time frame: 16 weeks

    Change in total energy intake (kcal/day), assessed using a 24-hour dietary recall administered by a trained nutritionist.

  19. Macronutrient intake

    Time frame: 16 weeks

    Change in macronutrient intake (g/day: proteins, total fats, carbohydrates, fiber), assessed using a 24-hour dietary recall administered by a trained nutritionist.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Carolina Cortez Ribeiro Research, PhD

CONTACT

[email protected]

+351938188980

Sponsors and collaborators

Lead sponsor

Instituto Politécnico de Bragança

Other

Collaborators

  • Universidade Federal do Paraná
  • Universidade do Porto

Registry information

Acronym: WPEPH

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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