Hypertension (HTN)NCT07242651
Tension and Trauma Releasing Exercises on Hypertensive Patients
A study testing Tension and trauma releasing exercises in people with Hypertension (HTN), run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Tension and trauma releasing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Nov 2025to 4 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Patients who are taking beta-blockers and alpha-blockers because these medications may affect heart rate.
- Individuals with endocrine disorders or any condition known to influence hormonal levels.
- Patients are smokers. h) Malignant hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tension and Trauma Releasing Exercises on Quality of Life and Sleep in Patients With Hypertension
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.
Read the 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.
- Conditions
- Hypertension (HTN)
- Being tested
- Tension and trauma releasing exercises
- Keywords
- Tension and trauma releasing exercises
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension and trauma releasing exercisesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| "TRE Exercise Group" | Experimental | 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. Receives: Behavioral: Tension and trauma releasing exercises |
| "Control Group" | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life ,assessed by SF12
Change in SF-12 physical and mental component summary scores from baseline to 8 weeks.
Measured: Baseline and after 8 weeks of intervention
Sleep quality, assessed by the Pittsburgh Sleep Quality Index (PSQI).
Change in global PSQI score from baseline to 8 weeks. PSQI will be administered to assess sleep quality .
Measured: Baseline and 8 weeks after the start of the intervention
Secondary outcomes (4)
Blood pressure - Systolic and Diastolic (mmHg) ,assessed by mercury sphygmomanometer
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.
Measured: Baseline and 8 weeks after the start of the intervention
Heart rate ,assessed by pulse oximeter
change in resting heart rate measured by pulse oximeter
Measured: Baseline and 8 weeks after the start of the intervention
Depression and anxiety ,assessed by Hospital Anxiety and Depression Scale (HADS)
Change in subscale (anxiety and depression) scores from baseline to 8 weeks.
Measured: Baseline and 8 weeks after the start of the intervention
Rate Pressure Product measurement
Heart rate * systolic blood pressure
Measured: Baseline and 8 weeks after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start18 Nov 2025
- Primary completion4 Mar 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youmna Gamal Abdelmouty Elsayed, Cairo University
- Investigators
- El-Sayed Essam Felaya, Assistant professor, Study chair, Cairo UniversitySalma Elsayed Elsheikh, Lecturer of physical therapy, Study chair, Cairo UniversityMahmoud Mohamed Ghanema, Lecturer of Internal Medicine, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242651
- Sponsor's protocol ID
- 111995
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tension and Trauma Releasing Exercises on Quality of Life and Sleep in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT07242651
- Acronym / sponsor ID
- 111995
- Conditions
- Hypertension (HTN)
- Keywords
- Tension and trauma releasing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| "TRE Exercise Group" | Experimental | Behavioral: Tension and trauma releasing exercisesParticipants 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. |
| "Control Group" | No intervention | –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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Patients who are taking beta-blockers and alpha-blockers because these medications may affect heart rate.
- Individuals with endocrine disorders or any condition known to influence hormonal levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tension and trauma releasing exercisesTension 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 | Behavioural | "TRE Exercise Group" |
Primary outcome
Quality of life ,assessed by SF12
Time frame: Baseline and after 8 weeks of intervention
Change in SF-12 physical and mental component summary scores from baseline to 8 weeks.
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 .
4 secondary outcomes
Blood pressure - Systolic and Diastolic (mmHg) ,assessed by mercury sphygmomanometer
Time frame: Baseline and 8 weeks after the start of the intervention
Heart rate ,assessed by pulse oximeter
Time frame: Baseline and 8 weeks after the start of the intervention
Depression and anxiety ,assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and 8 weeks after the start of the intervention
Rate Pressure Product measurement
Time frame: Baseline and 8 weeks after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
El-Sayed Essam Felaya, Assistant professor study chair
Cairo University
Salma Elsayed Elsheikh, Lecturer of physical therapy study chair
Cairo University
Mahmoud Mohamed Ghanema, Lecturer of Internal Medicine study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tension and trauma releasing exercises in people with Hypertension (HTN), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life ,assessed by SF12 (time frame: Baseline and after 8 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.