Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-07 @ 2:18 AM
Study NCT ID:
NCT07242651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tension and Trauma Releasing Exercises on Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study includes two parallel groups: the experimental group performs Tension and Trauma Releasing Exercises (TRE) in addition to medication, while the control group continues medication only.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life ,assessed by SF12', 'timeFrame': 'Baseline and after 8 weeks of intervention', 'description': 'Change in SF-12 physical and mental component summary scores from baseline to 8 weeks.'}, {'measure': 'Sleep quality, assessed by the Pittsburgh Sleep Quality Index (PSQI).', 'timeFrame': 'Baseline and 8 weeks after the start of the intervention', 'description': 'Change in global PSQI score from baseline to 8 weeks. PSQI will be administered to assess sleep quality .'}], 'secondaryOutcomes': [{'measure': 'Blood pressure - Systolic and Diastolic (mmHg) ,assessed by mercury sphygmomanometer', 'timeFrame': 'Baseline and 8 weeks after the start of the intervention', 'description': 'Mean change in systolic and diastolic blood pressure. Measurements will be taken using a mercury sphygmomanometer after a 5-minute rest period, and the average of two consecutive readings will be recorded.'}, {'measure': 'Heart rate ,assessed by pulse oximeter', 'timeFrame': 'Baseline and 8 weeks after the start of the intervention', 'description': 'change in resting heart rate measured by pulse oximeter'}, {'measure': 'Depression and anxiety ,assessed by Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline and 8 weeks after the start of the intervention', 'description': 'Change in subscale (anxiety and depression) scores from baseline to 8 weeks.'}, {'measure': 'Rate Pressure Product measurement', 'timeFrame': 'Baseline and 8 weeks after the start of the intervention', 'description': 'Heart rate \\* systolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tension and trauma releasing exercises'], 'conditions': ['Hypertension (HTN)']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of Tension and Trauma Releasing Exercises (TRE) on the quality of life and sleep in hypertensive patients. Participants will perform a series of supervised TRE sessions, and their sleep quality, and quality of life will be assessed before and after the intervention to determine any potential improvements related to the exercise.', 'detailedDescription': 'Forty females have had essential hypertension for at least five years. They will be recruited from the outpatient clinic at physical therapy, Cairo university.\n\nThe patients of this study will be randomly assigned into 2 equal groups (n=40):\n\nStudy Group A: (20 patients) Will receive Tension and Trauma Releasing Exercises in addition to medical treatment programme.\n\nControl Group B: (20 patients) will receive only the Medical treatment programme.\n\nThe program of treatment for the study group will be applied 30 minutes per session , with a maximum of 15 minutes of neurogenic tremors, 3 times per week for 8 consecutive weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'biological females only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants will be between 50 and 65 years of age.\n2. The BMI of patients will range between 30 and 34.9.\n3. Patients included in the study were diagnosed with essential hypertension for at least five years.\n4. The patients will be in stage 1 hypertension under medical control, characterized by systolic blood pressure ranging from 140 to 159 mmHg and diastolic blood pressure ranging from 90 to 99 mmHg.\n\nExclusion Criteria:\n\n1. Patients suffering from any unstable cardiovascular condition, such as uncontrolled arrhythmias or recent myocardial infarction.\n2. Patients are diagnosed with secondary hypertension.\n3. Patients with cognitive or physical impairments that prevent them from following instructions.\n\ne) Patients who are taking beta-blockers and alpha-blockers because these medications may affect heart rate.\n\nf) Individuals with endocrine disorders or any condition known to influence hormonal levels.\n\ng) Patients are smokers. h) Malignant hypertension.'}, 'identificationModule': {'nctId': 'NCT07242651', 'briefTitle': 'Tension and Trauma Releasing Exercises on Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Tension and Trauma Releasing Exercises on Quality of Life and Sleep in Patients With Hypertension', 'orgStudyIdInfo': {'id': '111995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"TRE Exercise Group"', 'description': 'Participants in this group will perform supervised Tension and Trauma Releasing Exercise (TRE) sessions in addition to their usual medical treatment for hypertension. The TRE sessions will be conducted three times per week for eight weeks, and each session will last approximately 30 minutes. The exercises aim to promote relaxation, reduce tension, and improve sleep quality, and quality of life.', 'interventionNames': ['Behavioral: Tension and trauma releasing exercises']}, {'type': 'NO_INTERVENTION', 'label': '"Control Group"', 'description': 'Participants in this group will continue their usual medical treatment for hypertension without any additional exercise intervention. They will receive the same assessments for sleep quality, and quality of life as the experimental group.'}], 'interventions': [{'name': 'Tension and trauma releasing exercises', 'type': 'BEHAVIORAL', 'description': 'Tension and trauma releasing exercises will be conducted for study group only as follows: The exercises start by slightly fatiguing specific muscle groups to encourage this involuntary shaking, which is considered healthy and calming.\n\nThe first exercise: Feet roll gently outward while shifting weight side to side, helping release ankle tension.\n\nThe second exercise: One foot steps back while the front heel lifts until the calf feels lightly tired, triggering a small shake.\n\nThe third exercise: A small lunge-like position engages the thighs and hips, leading to natural muscle release.\n\nThe fourth exercise: A soft bend at the hips with relaxed arms and deep breathing stretches the back and encourages loosening.\n\nThe fifth exercise: With feet wide and hands on the lower back, the hips push forward slightly while breathing deeply and turning gently side to side.\n\nThe sixth exercise: The body slides into a seated position against a wall to lightly fatigue the', 'armGroupLabels': ['"TRE Exercise Group"']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'contacts': [{'name': 'Youmna Gamal Elsayed, BSc. in Physical Therapy', 'role': 'CONTACT', 'email': 'yomnagamal27@gmail.com', 'phone': '+201273150655'}], 'facility': 'Faculty of physical therapy ,Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Youmna Gamal Elsayed, B.Sc. in Physical Therapy', 'role': 'CONTACT', 'email': 'yomnagamal27@gmail.com', 'phone': '+201273150655', 'phoneExt': '+201223348743'}], 'overallOfficials': [{'name': 'El-Sayed Essam Felaya, Assistant professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Salma Elsayed Elsheikh, Lecturer of physical therapy', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Mahmoud Mohamed Ghanema, Lecturer of Internal Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BSc. in Physical Therapy, Cairo University, 2018', 'investigatorFullName': 'Youmna Gamal Abdelmouty Elsayed', 'investigatorAffiliation': 'Cairo University'}}}}