- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07242651
Tension and Trauma Releasing Exercises on Hypertensive Patients
Effect of Tension and Trauma Releasing Exercises on Quality of Life and Sleep in Patients With Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Forty females have had essential hypertension for at least five years. They will be recruited from the outpatient clinic at physical therapy, Cairo university.
The patients of this study will be randomly assigned into 2 equal groups (n=40):
Study Group A: (20 patients) Will receive Tension and Trauma Releasing Exercises in addition to medical treatment programme.
Control Group B: (20 patients) will receive only the Medical treatment programme.
The 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Youmna Gamal Elsayed, B.Sc. in Physical Therapy
- Phone Number: +201223348743 +201273150655
- Email: yomnagamal27@gmail.com
Study Locations
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-
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Giza, Egypt
- faculty of physical therapy ,Cairo University
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Contact:
- Youmna Gamal Elsayed, BSc. in Physical Therapy
- Phone Number: +201273150655
- Email: yomnagamal27@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants will be between 50 and 65 years of age.
- The BMI of patients will range between 30 and 34.9.
- Patients included in the study were diagnosed with essential hypertension for at least five years.
- 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.
Exclusion Criteria:
- Patients suffering from any unstable cardiovascular condition, such as uncontrolled arrhythmias or recent myocardial infarction.
- Patients are diagnosed with secondary hypertension.
- Patients with cognitive or physical impairments that prevent them from following instructions.
e) Patients who are taking beta-blockers and alpha-blockers because these medications may affect heart rate.
f) Individuals with endocrine disorders or any condition known to influence hormonal levels.
g) Patients are smokers. h) Malignant hypertension.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "TRE Exercise Group"
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.
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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. The first exercise: Feet roll gently outward while shifting weight side to side, helping release ankle tension. The second exercise: One foot steps back while the front heel lifts until the calf feels lightly tired, triggering a small shake. The third exercise: A small lunge-like position engages the thighs and hips, leading to natural muscle release. The fourth exercise: A soft bend at the hips with relaxed arms and deep breathing stretches the back and encourages loosening. The 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. The sixth exercise: The body slides into a seated position against a wall to lightly fatigue the |
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No Intervention: "Control Group"
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life ,assessed by SF12
Time Frame: Baseline and after 8 weeks of intervention
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Change in SF-12 physical and mental component summary scores from baseline to 8 weeks.
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Baseline and after 8 weeks of intervention
|
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Sleep quality, assessed by the Pittsburgh Sleep Quality Index (PSQI).
Time Frame: Baseline and 8 weeks after the start of the intervention
|
Change in global PSQI score from baseline to 8 weeks.
PSQI will be administered to assess sleep quality .
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Baseline and 8 weeks after the start of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure - Systolic and Diastolic (mmHg) ,assessed by mercury sphygmomanometer
Time Frame: Baseline and 8 weeks after the start of the intervention
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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.
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Baseline and 8 weeks after the start of the intervention
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Heart rate ,assessed by pulse oximeter
Time Frame: Baseline and 8 weeks after the start of the intervention
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change in resting heart rate measured by pulse oximeter
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Baseline and 8 weeks after the start of the intervention
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Depression and anxiety ,assessed by Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline and 8 weeks after the start of the intervention
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Change in subscale (anxiety and depression) scores from baseline to 8 weeks.
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Baseline and 8 weeks after the start of the intervention
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Rate Pressure Product measurement
Time Frame: Baseline and 8 weeks after the start of the intervention
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Heart rate * systolic blood pressure
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Baseline and 8 weeks after the start of the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: El-Sayed Essam Felaya, Assistant professor, Cairo University
- Study Chair: Salma Elsayed Elsheikh, Lecturer of physical therapy, Cairo University
- Study Chair: Mahmoud Mohamed Ghanema, Lecturer of Internal Medicine, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111995
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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