NCT06950463

Brief Summary

This study will be conducted to determine the effect of circuit training on bone mineral density in post menopausal period.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 17, 2025

Last Update Submit

April 25, 2025

Conditions

Keywords

CIRCUIT TRAINING, BONE MINERAL DENSITY, POST MENOPAUSAL PERIOD

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    A dual-energy x-ray absorptiometry (Hologic Delphi Dexa Scanner) (DEXA): It will be used to assess the bone mineral density for all women in both groups (A and B) before and after the end of the study program.

    6 months

Study Arms (1)

All patients will be divided randomly into two equal groups (A & B): Group A (control group)

EXPERIMENTAL

All patients will be divided randomly into two equal groups (A \& B): Group A (control group): It will be consisted of twenty two post menopausal women who will receive daily dosage of vitamin D3 supplement (600 IU/day) (Schleicher et al., 2016), for 6 weeks as prescribed by the gynecologist, in addition to general advices. Group B (Study group): It will be consisted of twenty two post menopausal women who will receive the same prescribed program of group (A) in addition to circuit weight training , 50 to 60 minutes/session ,3 sessions per week, for 6 weeks in total. . All post menopausal women in both groups (A\&B) will be given a full explanation of the study protocol and consent form will be signed by each woman before participating in the study.

Other: Group A (control group): It will be consisted of twenty two post menopausal women who will receive daily dosage of vitamin D3 supplement (600 IU/day) (Schleicher et al., 2016), for 6 weekDevice: 1-Dumbbells (set B08Z7SY6SP ,Gymbit , made in China) :They will be used for the treatment procedures of circuit training for all postmenopausal women in group B. Its surface is coated with vinyl fo

Interventions

1-Dumbbells (set B08Z7SY6SP ,Gymbit , made in China) :They will be used for the treatment procedures of circuit training for all postmenopausal women in group B. Its surface is coated with vinyl for scratch resistance and to provide them with a firm grip, even if their hands are sweaty. This dumbbell set consists of two dumbbells weighing 2 kg each, with dimensions of 21.7 x 15.7 x 8.5 cm; 4 kg.

All patients will be divided randomly into two equal groups (A & B): Group A (control group)

1-Dumbbells (set B08Z7SY6SP ,Gymbit , made in China) :They will be used for the treatment procedures of circuit training for all postmenopausal women in group B. Its surface is coated with vinyl for scratch resistance and to provide them with a firm grip, even if their hands are sweaty. This dumbbell set consists of two dumbbells weighing 2 kg each, with dimensions of 21.7 x 15.7 x 8.5 cm; 4 kg.

All patients will be divided randomly into two equal groups (A & B): Group A (control group)

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Post menopausal women (at least 12 months after cessation of menstruation. Their ages will range from 50 -60 years old. Their body mass index (BMI) will be less than 30 Kg/m2. All of them have vitamin D potential deficiency (insufficiency) from 30nmol to 50nmol .
  • Their T-score on DEXA will range from -1.1 to -2.4 indicates osteopenia or low bone density.
  • They must be able to ambulate independently. All of them must be sedentary life style.

You may not qualify if:

  • All women will be excluded if they have one of the following criteria:
  • Thyroid, kidney and liver dysfunction. Cardiovascular diseases, severe anemia, uncontrolled diabetes mellitus. Any chest surgery, chronic obstructive pulmonary disease, malignancy. Renal failure, myocardial infarction, myasthenia gravis, hyperthyroidism. Hemorrhage, acute viral disease, acute tuberculosis, mental disorders, or those with pacemakers.
  • Musculoskeletal disorders or women who received corticosteroids in the last 6 months prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient-clinic of Gynecology and Obstetrics in Mashtoul Elsouq Central Hospital, Egypt.

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Noha Lotfy ElShater, Bachelor's degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients will be divided randomly into two equal groups (A \& B): Group A (control group): It will be consisted of twenty two post menopausal women who will receive daily dosage of vitamin D3 supplement (600 IU/day) (Schleicher et al., 2016), for 6 weeks as prescribed by the gynecologist, in addition to general advices. Group B (Study group): It will be consisted of twenty two post menopausal women who will receive the same prescribed program of group (A) in addition to circuit weight training , 50 to 60 minutes/session ,3 sessions per week, for 6 weeks in total. . All post menopausal women in both groups (A\&B) will be given a full explanation of the study protocol and consent form will be signed by each woman before participating in the study (Appendix I).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 30, 2025

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations