Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:18 AM
Study NCT ID:
NCT07403305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovascular Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)', 'timeFrame': '16 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6 (IL-6)', 'timeFrame': '16 weeks', 'description': 'Change in serum interleukin-6 (IL-6) concentration (pg/mL), measured by enzyme-linked immunosorbent assay (ELISA)'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': '16 weeks', 'description': 'Change in serum C-reactive protein concentration (mg/L) measured by chemiluminescent microparticle immunoassay (CMIA).'}, {'measure': 'Plasma Glucose', 'timeFrame': '16 weeks', 'description': 'Change in fasting plasma glucose concentration (mg/dL), measured using standard laboratory methods.'}, {'measure': 'Insulin', 'timeFrame': '16 weeks', 'description': 'Change in fasting serum insulin concentration (µIU/mL), measured using standard laboratory methods.'}, {'measure': 'Hemoglobin A1C (HbA1c)', 'timeFrame': '16 weeks', 'description': 'Change in glycated hemoglobin (HbA1c, %), measured using standard laboratory methods.'}, {'measure': 'Hepatic enzymes', 'timeFrame': '16 weeks', 'description': 'Change in serum aspartate transaminase (AST) activity (U/L), alanine transaminase (ALT) activity (U/L), measured by enzymatic spectrophotometry.'}, {'measure': 'Bilirubin', 'timeFrame': '16 weeks', 'description': 'Change in total bilirubin concentration (mg/dL), measured by enzymatic spectrophotometry.'}, {'measure': 'Blood pressure', 'timeFrame': '16 weeks', 'description': '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.'}, {'measure': 'Waist and hip circumferences', 'timeFrame': '16 weeks', 'description': 'Change in waist circumference (cm) and hip circumference (cm), measured using a non-elastic measuring tape according to ISAK protocols.'}, {'measure': 'Body composition', 'timeFrame': '16 weeks', 'description': '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).'}, {'measure': 'Bone mineral density', 'timeFrame': '16 weeks', 'description': 'Change in bone mineral density (g/cm²) from baseline to 16 weeks, assessed by dual-energy X-ray absorptiometry (DXA).'}, {'measure': 'Maximal oxygen uptake (VO₂ max)', 'timeFrame': '16 weeks', 'description': 'Change in maximal oxygen uptake (mL/kg/min), assessed using a graded treadmill exercise test to volitional exhaustion.'}, {'measure': 'Isokinetic muscle strength', 'timeFrame': '16 weeks', 'description': '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.'}, {'measure': 'Sleep quality', 'timeFrame': '16 weeks', 'description': 'Change in sleep quality score, assessed by the Pittsburgh Sleep Quality Index (PSQI; score range 0-21, higher scores indicate worse sleep quality).'}, {'measure': 'Health-related quality of life', 'timeFrame': '16 weeks', 'description': '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).'}, {'measure': 'Pain intensity', 'timeFrame': '16 weeks', 'description': '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).'}, {'measure': 'Psychosocial risk factors', 'timeFrame': '16 weeks', 'description': '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).'}, {'measure': 'Total energy intake', 'timeFrame': '16 weeks', 'description': 'Change in total energy intake (kcal/day), assessed using a 24-hour dietary recall administered by a trained nutritionist.'}, {'measure': 'Macronutrient intake', 'timeFrame': '16 weeks', 'description': 'Change in macronutrient intake (g/day: proteins, total fats, carbohydrates, fiber), assessed using a 24-hour dietary recall administered by a trained nutritionist.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thermal Water', 'Water Exercise', 'Hydropinotherapy', 'Lipid Profile', 'Cardiovascular Health'], 'conditions': ['Cardiovascular (CV) Risk']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants will be randomizate into four arms:\n\n* Arm I: Control\n* Arm II: Water Physical Exercise Program (WPEP) in thermal water\n* Arm III: Hydropinotherapy with thermal water combined with bay leaf (L. nobilis)\n* Arm IV: WPEP in thermal water and hydropinotherapy with thermal water combined with bay leaf (L. nobilis)\n\nPrimary outcome:\n\n1. Lipid profile (cholesterol total, low-density lipoprotein cholesterol (c-LDL), high-density lipoprotein cholesterol (c-HDL), triglycerides)\n\n Secondary parameters:\n2. Inflammatory biomarkers: interleukin-6 (IL-6), C-reactive protein (CRP)\n3. Glucose metabolisc: fasting plasma glucose, insulin, Hemoglobin A1c (HbA1c)\n4. Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, bilirubin, creatinine.\n5. Anthropometric and clinical variables: weight, waist to hip ratio, body composition and bone mineral density\n6. Systolic and diastolic blood pressure\n7. Physical function\n8. Lifestyle parameters: sleep quality, quality of life and eating habits'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women\n* Age: \\>45 years\n* Written informed consent prior to participation\n* Physical condition suitable for participating in physical exercise activities\n* Controlled health conditions\n\nExclusion Criteria:\n\n* History of chronic or severe diseases that may affect study outcomes or limit study participation, such as:\n* Decompensated cardiovascular disease, renal insufficiency, or severe liver disease\n* Conditions preventing the ability in physical activity (e.g., severe respiratory issues, reduced mobility, severe arthritis)\n* Severe psychiatric or cognitive disorders that could affect comprehension or adherence to the study\n* Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or corticosteroids\n* Pregnancy or lactation\n* Less than 80% attendance at the 16-week aquatic exercise program'}, 'identificationModule': {'nctId': 'NCT07403305', 'acronym': 'WPEPH', 'briefTitle': 'The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovascular Health', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Politécnico de Bragança'}, 'officialTitle': 'The Effect of Water Physical Exercise Program in Thermal Water and Hydropinotherapy on Cardiovascular Health', 'orgStudyIdInfo': {'id': 'IPBraganca'}, 'secondaryIdInfos': [{'id': 'UIDB/00690/2020; UIDP/00690', 'type': 'OTHER_GRANT', 'domain': 'Fundação para Ciência e Tecnologia'}, {'id': 'LA/P/0007/2020', 'type': 'OTHER_GRANT', 'domain': 'Fundação para Ciência e Tecnologia'}, {'id': 'UIDB/00617/2020, LA/P/0064/202', 'type': 'OTHER_GRANT', 'domain': 'Fundação para Ciência e Tecnologia (FCT)'}, {'id': 'PRT/BD/154584/2023', 'type': 'OTHER_GRANT', 'domain': 'Fundação para Ciência e Tecnologia (FCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm I: Control', 'description': 'Control'}, {'type': 'OTHER', 'label': 'Arm II: WPEP in thermal water', 'description': 'Water Physical Exercise Program in thermal water', 'interventionNames': ['Behavioral: WPEP in thermal water']}, {'type': 'OTHER', 'label': 'Arm III: Hydropinotherapy', 'description': 'Hydropinotherapy with thermal water combined with bay leaf (L. nobilis)', 'interventionNames': ['Other: Hydropinotherapy']}, {'type': 'OTHER', 'label': 'Arm IV: WPEP in thermal water + Hydropinotherapy', 'description': 'Water Physical Exercise Program in thermal water in thermal water and hydropinotherapy with thermal water combined with bay leaf (L. nobilis)', 'interventionNames': ['Behavioral: WPEP in thermal water', 'Other: Hydropinotherapy']}], 'interventions': [{'name': 'WPEP in thermal water', 'type': 'BEHAVIORAL', 'description': '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.\n\nEach 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.', 'armGroupLabels': ['Arm II: WPEP in thermal water', 'Arm IV: WPEP in thermal water + Hydropinotherapy']}, {'name': 'Hydropinotherapy', 'type': 'OTHER', 'description': '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.\n\nThe 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.', 'armGroupLabels': ['Arm III: Hydropinotherapy', 'Arm IV: WPEP in thermal water + Hydropinotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anna Carolina Cortez Ribeiro Research, PhD', 'role': 'CONTACT', 'email': 'anna.cortez@ipb.pt', 'phone': '+351938188980'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Politécnico de Bragança', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade do Porto', 'class': 'OTHER'}, {'name': 'Universidade Federal do Paraná', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Carolina Cortez Ribeiro', 'investigatorAffiliation': 'Instituto Politécnico de Bragança'}}}}