NCT07683286

Brief Summary

This study aims to compare the effect of pilates exercises versus intermittent fasting diet on physical and metabolic aging parameters in obese perimenopausal women.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress16%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

June 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2027

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 28, 2026

Last Update Submit

June 28, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (8)

  • Body weight

    Weight will be measured in kilograms by weight-height scale for all participants before and after treatment program.

    12 weeks

  • Body mass index

    It will be measured by weight-height scale by dividing body weight in kilograms by height meter square.

    12 weeks

  • Waist circumference

    The waist circumference will be measured in centimeters at the narrowest point between xipho-sternum and the iliac crest at the end of a gentle expiration.

    12 weeks

  • Hip circumference

    Hip circumference will be measured in centimeters at the maximum circumference at the level of the femoral trochanter.

    12 weeks

  • Waist-hip ratio

    It will be calculated by dividing waist circumference by hip circumference for all participants before and after treatment.

    12 weeks

  • Resting Heart Rate Measurement

    Resting heart rate (RHR) is the number of heartbeats per minute (bpm) when a person is at complete rest. It is a simple indicator of cardiovascular health. it will be measured by pulse oximeter. Normal Range: Adults: 60-100 bpm

    12 weeks

  • Maximum Heart Rate

    It will be calculated through equation: 220- age

    12 weeks

  • Maximum oxygen consumption (VO2 max)

    It will be calculated through the equation:VO2 max = 15.3 x (maximum heart rate / resting heart rate).

    12 weeks

Secondary Outcomes (6)

  • Assessment of the health-related quality of life

    12 weeks

  • Total cholesterol (TC)

    12 weeks

  • Triglycerides

    Normal: <150 mg/dL (<1.7 mmol/L)

  • High-density lipoprotein

    12 weeks

  • Low-density lipoprotein

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Pilates exercise group

EXPERIMENTAL

The participants will be treated with Pilates exercises, 4 times per week, 60 minutes per session, for 12 weeks.

Other: Pilates exercise

Intermittent Fasting Diet

EXPERIMENTAL

The participants will follow intermittent fasting diet for 12 weeks.

Other: Intermittent Fasting Diet

Interventions

Pilates exerciseOTHER

Each exercise will be ranged from 1 to 3 minutes, with a break of 10 seconds. The exercises include: Flat Abs: Pilates Hundred; Flat Abs: Roll-Up; Obliques: Twist and Reach; Lower Back: Shoulder Bridge; Lower Body: Kneeling Side Kicks; Lower Body: Leg Swings; Stamina: Wall Chair.

Pilates exercise group
Intermittent Fasting DietOTHER

This fasting regimen involves fasting for 16 hours each day and limiting eating to an 8-hour window. The 16:8 intermittent fasting protocol is relatively straightforward. It divides the day into two main periods: the fasting period which is 16 hours and the 8 hours eating window .

Intermittent Fasting Diet

Eligibility Criteria

Age40 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Their body mass index will be ranged from 30 to 35 kg/m2.
  • Waist hip ratio will be \> 1.
  • Total cholesterol (TC) will be \> 200 mg/dl.
  • Triglycerides (TG) will be \> 150 mg/dl.
  • Low-density lipoprotein (LDL) will be \> 100 mg/dl.
  • High-density lipoprotein (HDL) will be \< 40 mg/dl.

You may not qualify if:

  • Diabetes type I.
  • Concomitant cardiac disorders.
  • Pregnant or breastfeeding.
  • Eating disorders as Anorexia.
  • Thyroid disorders.
  • Kidney disorders.
  • Severe joint issues as arthritis and post-joint replacement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadeel Adil Mohamed

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Doaa Osman, As Professor

    Cairo University

    STUDY DIRECTOR

  • Mohamed Awad, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Hadeel Mohammed, Master

CONTACT

01065489193hadeltv@yahoo.com

Mohamed Abo Eleinien, PHD

CONTACT

01001414404Drfawzygyna61@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 28, 2026

First Posted

July 6, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 16, 2027

Last Updated

July 6, 2026

Record last verified: 2026-06

Locations

EG(1)