Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients

NCT ID: NCT06315764

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-05-30

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).

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic training

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

Group Type: EXPERIMENTAL

Reflexology

Intervention Type: 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

Reflexology

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 .

Group Type: EXPERIMENTAL

Reflexology

Intervention Type: 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

Interventions

Reflexology

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

Intervention Type: PROCEDURE

Other Intervention Names

Aerobic training

Eligibility Criteria

Inclusion Criteria

1. Forty hypertensive patients aged 35 to 45 years of both sexes (men and women).

2. Clinical and medically, all of the participants were in good health.

3. The BMI ranged from 30 to 34.9 kg/m2 for all participants.

Exclusion Criteria

1. Close Myocardial infarcts.

2. Heart block or complex ventricular arrhythmia

3. Cerebrovascular disease is a condition in which the blood vessels in the brain become inflamed.

4. Defects in vision or hearing.

5. Significant tightness in the lower limbs and/or a fixed deformity of lower limbs.

6. Balance or mentality-related neurological diseases (e.g. epilepsy).

7. Abnormalities of lower limb that may be congenital or acquired.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Ahmed Mousa Galeb

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

heba mousa

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Heba Mousa

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 27604656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28748919 (View on PubMed)

Other Identifiers

Hypertensive patients

Identifier Type: -

Identifier Source: org_study_id