NCT07242651

Brief 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 determine any potential improvements related to the exercise.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Nov 2025Jun 2026

First Submitted

Initial submission to the registry

November 17, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 18, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2026

Expected
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Tension and trauma releasing exercises

Outcome Measures

Primary Outcomes (2)

  • Quality of life ,assessed by SF12

    Change in SF-12 physical and mental component summary scores from baseline to 8 weeks.

    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 .

    Baseline and 8 weeks after the start of the intervention

Secondary Outcomes (4)

  • Blood pressure - Systolic and Diastolic (mmHg) ,assessed by mercury sphygmomanometer

    Baseline and 8 weeks after the start of the intervention

  • Heart rate ,assessed by pulse oximeter

    Baseline and 8 weeks after the start of the intervention

  • Depression and anxiety ,assessed by Hospital Anxiety and Depression Scale (HADS)

    Baseline and 8 weeks after the start of the intervention

  • Rate Pressure Product measurement

    Baseline and 8 weeks after the start of the intervention

Study Arms (2)

"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.

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.

Interventions

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

"TRE Exercise Group"

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbiological females only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy ,Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • 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 CHAIR

Central Study Contacts

Youmna Gamal Elsayed, B.Sc. in Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc. in Physical Therapy, Cairo University, 2018

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

November 18, 2025

Primary Completion

March 4, 2026

Study Completion (Estimated)

June 4, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations