Effect of Whole Body Vibration on Blood Pressure in Obese Postmenopausal Women.

Effect of Whole Body Vibration on Blood Pressure in Obese Postmenopausal Women. A Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: energy-restricted diet; Device: Whole body vibration

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Maged; Phone Number: +201005227404; Email: Ahmedmaged@cu.edu.eg
• Study Contact Backup: Name: Wafaa Kamal; Phone Number: 01006914119; Email: wafaa_kamal37@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 12111
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet regimen group; 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.	Dietary supplement: energy-restricted diet; 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.
Active Comparator: whole body vibration group; For 8 weeks, WBV participants completed 3 supervised training sessions a week. 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.	Dietary supplement: energy-restricted diet; 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.; Device: Whole body vibration; For 8 weeks, WBV participants completed 3 supervised training sessions a week. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure measurement	The auscultatory method of measuring both systolic and diastolic blood pressure was used with a sphygmomanometer properly calibrated and validated	before and after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurements	using standardized equipment (Weight and height scale). Height of all participants were measured in standing position without footwear. Body mass index was then calculated	before and after 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed M Maged, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 70

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No