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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
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.
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.
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.
Time frame: 16 weeks
Interleukin-6 (IL-6)
Change in serum interleukin-6 (IL-6) concentration (pg/mL), measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: 16 weeks
C-reactive protein (CRP)
Change in serum C-reactive protein concentration (mg/L) measured by chemiluminescent microparticle immunoassay (CMIA).
Time frame: 16 weeks
Plasma Glucose
Change in fasting plasma glucose concentration (mg/dL), measured using standard laboratory methods.
Time frame: 16 weeks
Insulin
Change in fasting serum insulin concentration (µIU/mL), measured using standard laboratory methods.
Time frame: 16 weeks
Hemoglobin A1C (HbA1c)
Change in glycated hemoglobin (HbA1c, %), measured using standard laboratory methods.
Time frame: 16 weeks
Hepatic enzymes
Change in serum aspartate transaminase (AST) activity (U/L), alanine transaminase (ALT) activity (U/L), measured by enzymatic spectrophotometry.
Time frame: 16 weeks
Bilirubin
Change in total bilirubin concentration (mg/dL), measured by enzymatic spectrophotometry.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 16 weeks
Total energy intake
Change in total energy intake (kcal/day), assessed using a 24-hour dietary recall administered by a trained nutritionist.
Time frame: 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.
Time frame: 16 weeks
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