Clinical trial NCT05991050: Effect of Whole Body Vibration on Blood Pressure in Obese Postmenopausal Women.
Official title: Effect of Whole Body Vibration on Blood Pressure in Obese Postmenopausal Women. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.Group B (WBV group):

For 8 weeks, WBV participants completed 3 supervised training sessions a week.

Detailed description: I-Group A (control group):

All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.

II-Group B (WBV group):

For 8 weeks, WBV participants completed 3 supervised training sessions a week. Each participant received an explanation of the WBV device and the treatment protocol. Women stood in upright position and hold on handle bar before switching the WBV device at "on" position.

The exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee ﬂexion "squats with 90° knee angle, semi-squats with 120° knee angle" and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions. All dynamic exercises were performed with slow controlled movements and between each set, there was resting period during which women assumed upright standing position for 1 minute. Total duration of the training session was 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Age 55 -65 years
* BMI 30 to 34.99 Kg / m2
* prehypertension and hypertension stage I

Exclusion Criteria:

* systolic blood pressure exceeding 159 mm Hg and diastolic blood pressure exceeding 99 mm Hg,
* diabetic neuropathy disease,
* patients with mental or psychological disorders,
* skin disorders or bleeding disorders, and
* musculoskeletal disorders that limited WBV.

Primary outcomes:
measure: Blood pressure measurement
timeFrame: before and after 8 weeks of treatment
Secondary outcomes:
measure: Anthropometric measurements
timeFrame: before and after 8 weeks of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Ahmed M Maged
role: PRINCIPAL_INVESTIGATOR
References: