NCT05991050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 6, 2023

Last Update Submit

August 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Anthropometric measurements

    before and after 8 weeks of treatment

Study Arms (2)

Diet regimen group

ACTIVE COMPARATOR

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

whole body vibration group

ACTIVE COMPARATOR

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 dietDevice: Whole body vibration

Interventions

energy-restricted dietDIETARY_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.

Diet regimen groupwhole 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.

whole body vibration group

Eligibility Criteria

Age55 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ahmed M Maged

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 14, 2023

Study Start

August 1, 2023

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations