The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)
研究概览
简要总结
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: 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •Age: >45 years
- •Written informed consent prior to participation
- •Physical condition suitable for participating in physical exercise activities
- •Controlled health conditions
排除标准
- •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
研究组 & 干预措施
Arm I: Control
Control
Arm II: WPEP in thermal water
Water Physical Exercise Program in thermal water
干预措施: WPEP in thermal water (Behavioral)
Arm III: Hydropinotherapy
Hydropinotherapy with thermal water combined with bay leaf (L. nobilis)
干预措施: Hydropinotherapy (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)
干预措施: Hydropinotherapy (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)
干预措施: WPEP in thermal water (Behavioral)
结局指标
主要结局
Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)
时间窗: 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.
次要结局
- Sleep quality(16 weeks)
- Isokinetic muscle strength(16 weeks)
- Health-related quality of life(16 weeks)
- Pain intensity(16 weeks)
- Psychosocial risk factors(16 weeks)
- Total energy intake(16 weeks)
- Macronutrient intake(16 weeks)
- Hepatic enzymes(16 weeks)
- Bilirubin(16 weeks)
- Blood pressure(16 weeks)
- Waist and hip circumferences(16 weeks)
- Body composition(16 weeks)
- Bone mineral density(16 weeks)
- Maximal oxygen uptake (VO₂ max)(16 weeks)
- Interleukin-6 (IL-6)(16 weeks)
- C-reactive protein (CRP)(16 weeks)
- Plasma Glucose(16 weeks)
- Insulin(16 weeks)
- Hemoglobin A1C (HbA1c)(16 weeks)
研究者
Anna Carolina Cortez Ribeiro
Principal Investigator
Instituto Politécnico de Bragança