Clinical trial NCT06315764: Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients
Official title: Effect of the Reflexology Versus Aerobic Training on Insomnia Severity Index and Quality of Life in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Reflexology, Insomina Severity Index; Hypertensive patients.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Insomnia severity index
timeFrame: four weeks then four weeks( eight weeks)
measure: Short form 36 quality of life questionnaire (SF-36):
timeFrame: four weeks then four weeks( eight weeks)
measure: Blood pressure measurements:
timeFrame: four weeks then four weeks( eight weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Heba Mousa
Study officials:
affiliation: Cairo University
name: heba mousa
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.