Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients

NCT06315764 | Completed

• 1 other identifier: Hypertensive patients
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

Reflexology, Insomina Severity Index; Hypertensive patients.

Outcome Measures

Primary Outcomes (3)

• Insomnia severity index

  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.

  four weeks then four weeks( eight weeks)

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

  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

  four weeks then four weeks( eight weeks)

• Blood pressure measurements:

  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.

  four weeks then four weeks( eight weeks)

Study Arms (2)

Aerobic training

EXPERIMENTAL

Each patient in this study did 20 minutes of peddler aerobic training, with the first 5 minutes serving as a warm-up with intensity set at 60 - 65 percent of maximal heart rate, followed by another 10 minutes of peddler training with intensity gradually increased up to 70 - 75 percent, and the last 5 minutes serving as a cooling down with intensity set at 60 - 65 percent of maximal heart rate. After the warm-up and at the end of each training phase, the participants' heart rates were monitored. Finally, if the individual experienced pain, fainting, or shortness of breath, the training was promptly terminated

Procedure: Reflexology

Reflexology

EXPERIMENTAL

This group consisted of twenty female patients suffering from hypertension who received the same drugs as group (A) as well as reflexology three times per week for eight weeks . Following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).Before and after the foot reflexology, blood pressure was checked twice. Around 20 minutes is spent on foot reflexology .

Procedure: Reflexology

Interventions

Reflexology PROCEDURE

Following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).Before and after the foot reflexology, blood pressure was checked twice. Around 20 minutes is spent on foot reflexology . Each patient in this study did 20 minutes of peddler aerobic training, with the first 5 minutes serving as a warm-up with intensity set at 60 - 65 percent of maximal heart rate, followed by another 10 minutes of peddler training with intensity gradually increased up to 70 - 75 percent, and the last 5 minutes serving as a cooling down with intensity set at 60 - 65 percent of maximal heart rate. After the warm-up and at the end of each training phase, the participants' heart rates were monitored. Finally, if the individual experienced pain, fainting, or shortness of breath, the training was promptly terminated as well as reflexology three times each week for eight weeks

Also known as: Aerobic training

Aerobic training; Reflexology

Eligibility Criteria

• Age: 35 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Heba Mousa

Cairo, 11517, Egypt

Location

Related Publications (2)

• Boutcher YN, Boutcher SH. Exercise intensity and hypertension: what's new? J Hum Hypertens. 2017 Mar;31(3):157-164. doi: 10.1038/jhh.2016.62. Epub 2016 Sep 8.

  PMID: 27604656 BACKGROUND

• Gudsoorkar PS, Tobe SW. Changing concepts in hypertension management. J Hum Hypertens. 2017 Dec;31(12):763-767. doi: 10.1038/jhh.2017.57. Epub 2017 Jul 27.

  PMID: 28748919 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• heba mousa

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at the Department of Physical Therapy for Cardiovascular /Respiratory Disorders and Geriatrics Faculty of Physical Therapy

Model Details: Group (A): It consists of twenty female patients suffering from hypertension who underwent medical treatment as well as peddler training three times per week for eight weeks. After four weeks of treatment (post-1) and another four weeks of treatment, the post evaluation was used (post-2). Group (B): This group consisted of twenty female patients suffering from hypertension who received the same drugs as group (A) as well as reflexology three times per week for eight weeks

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2022
• Primary Completion: January 30, 2022
• Study Completion: May 30, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

EG (1)