NCT05795504

Brief Summary

A comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

March 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

March 21, 2023

Last Update Submit

August 19, 2024

Conditions

Vitamin D DeficiencyCalciumPremenopause

Outcome Measures

Primary Outcomes (2)

  • Vitamin D serum level

    a blood sample of each participant will be taken to measure serum vitamin D level before and after the study

    three months

  • serum calcium level

    a blood sample will be taken from each participant to measure calcium level of each participant before and after the study.

    three months

Study Arms (3)

resistive exercises

EXPERIMENTAL

Premenopausal women in group A will perform resistive exercise for upper and lower limbs, three times per week in addition to calcium and vitamin d supplementations.

Other: resistive exerciseDietary Supplement: calcium and vitamin D

high intensity interval training

EXPERIMENTAL

Premenopausal women in group B will receive high intensity interval training for three times per week in addition to calcium and vitamin D supplementations

Other: high intensity interval trainingDietary Supplement: calcium and vitamin D

conventional therapy

ACTIVE COMPARATOR

Premenopausal women in group C will receive calcium and vitamin D supplementations only.

Dietary Supplement: calcium and vitamin D

Interventions

resistive exerciseOTHER

They will perform combined upper and lower resistive exercises, 30 min, 3 sessions / week for 12 weeks in addition to calcium and vitamin D supplements.

resistive exercises
high intensity interval trainingOTHER

They will perform HIIT for three sessions/ week for 12 weeks, 30 minutes/ session in addition to calcium and vitamin D supplements.,

high intensity interval training
calcium and vitamin DDIETARY_SUPPLEMENT

they will receive calcium and vitamin D supplements only.

conventional therapyhigh intensity interval trainingresistive exercises

Eligibility Criteria

Age40 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women having reduced calcium level (less than 500mg) intake as recorded by 24 hours' dietary recall method and vitamin D deficiency (12-19 ng/ml).
  • Their ages will range from 40 to 45 years.
  • Their BMI will range from 25-30 kg/m2.
  • Don't receive hormonal replacement therapy.

You may not qualify if:

  • Smoking.
  • History of chronic disease (uncontrolled hypertension, diabetes mellitus)
  • Osteoporosis.
  • severe musculoskeletal disorders
  • cardiovascular disease, thyroid dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Egypt

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

High-Intensity Interval TrainingCalciumVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Mai shehata

    faculty of physical therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for women's health

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

March 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 15, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)