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

NCT ID: NCT05991050

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-03-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

energy-restricted diet

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: ACTIVE_COMPARATOR

energy-restricted diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Whole body vibration

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Maged

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Central Contacts

Ahmed M Maged

Role: CONTACT

Ahmedmaged@cu.edu.eg

+201005227404

Wafaa Kamal

Role: CONTACT

wafaa_kamal37@yahoo.com

01006914119

Other Identifiers

70

Identifier Type: -

Identifier Source: org_study_id