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Clinical Trials/NCT06315764
NCT06315764
Completed
Not Applicable

Effect of the Reflexology Versus Aerobic Training on Insomnia Severity Index and Quality of Life in Hypertensive Patients

Cairo University1 site in 1 country40 target enrollmentJanuary 1, 2022
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Cairo University
Enrollment
40
Locations
1
Primary Endpoint
Blood pressure measurements:
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life.

Detailed Description

The participated subjects were enrolled based on the inclusion and exclusion criteria , In this study, forty hypertensive female patients between 35 and 45 were divided to two equal groups (A and B). Twenty female patients in group (A) got medications and peddling training, while twenty female patients in group (B) had the exact treatment as group (A) as well as reflexology. Insomina severity index and a short form 36 quality of life questionnaire were used to assess the patients who took part in the study (ISI). They were assessed before and after the eight-week treatment program, which consisted of three sessions each week; following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
May 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heba Ahmed Mousa Galeb

Lecturer at the Department of Physical Therapy for Cardiovascular /Respiratory Disorders and Geriatrics Faculty of Physical Therapy

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Forty hypertensive patients aged 35 to 45 years of both sexes (men and women).
  • Clinical and medically, all of the participants were in good health.
  • The BMI ranged from 30 to 34.9 kg/m2 for all participants.

Exclusion Criteria

  • Close Myocardial infarcts.
  • Heart block or complex ventricular arrhythmia
  • Cerebrovascular disease is a condition in which the blood vessels in the brain become inflamed.
  • Defects in vision or hearing.
  • Significant tightness in the lower limbs and/or a fixed deformity of lower limbs.
  • Balance or mentality-related neurological diseases (e.g. epilepsy).
  • Abnormalities of lower limb that may be congenital or acquired.

Outcomes

Primary Outcomes

Blood pressure measurements:

Time Frame: four weeks then four weeks( eight weeks)

it consisted of systolic blood pressure which measures the pressure in arteries when heart beats and diastolic blood pressure which measures the pressure in arteries when heart rests between beats.

Insomnia severity index

Time Frame: four weeks then four weeks( eight weeks)

The Insomnia severity index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The higher score is the worse outcome.

Short form 36 quality of life questionnaire (SF-36):

Time Frame: four weeks then four weeks( eight weeks)

it is used for measuring health-related quality of life (HRQL) which consists of 36 questions (SF-36) (limitations on physical functioning because of health problems), it was done personal interviewing using Arabic version

Study Sites (1)

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