Resistive Exercise Versus HIIT on Calcium and Vitamin D

Resistive Exercise Versus High Intensity Interval Training on Calcium and Vitamin D in Premenopausal Women: A Randomized Controlled Trial

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Vitamin D Deficiency; Premenopause; Calcium
• Intervention / Treatment: Other: resistive exercise; Dietary supplement: calcium and vitamin D; Other: high intensity interval training

Detailed Description

A total of 57% of women were vitamin D deficient with higher vitamin D deficiency found among premenopausal women (64.7%). Concentrations of 25(OH) D, defined as severely deficient (< 12 ng/ml), deficient (12-19 ng/ml), insufficient (20-30 ng/ml) and sufficient (> 30 ng/ml). Both severe vitamin D deficiency and calcium deficiency was significantly more frequent in premenopausal women compared to postmenopausal women. So, it is important to find effective therapeutic approaches to treat vitamin D deficiency among these women

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: resistive exercises; 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 exercise; 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.; Dietary supplement: calcium and vitamin D; they will receive calcium and vitamin D supplements only.
Experimental: high intensity interval training; Premenopausal women in group B will receive high intensity interval training for three times per week in addition to calcium and vitamin D supplementations	Dietary supplement: calcium and vitamin D; they will receive calcium and vitamin D supplements only.; Other: high intensity interval training; They will perform HIIT for three sessions/ week for 12 weeks, 30 minutes/ session in addition to calcium and vitamin D supplements.,
Active Comparator: conventional therapy; Premenopausal women in group C will receive calcium and vitamin D supplementations only.	Dietary supplement: calcium and vitamin D; they will receive calcium and vitamin D supplements only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mai shehata, Faculty of Physical Therapy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium
• Other Study ID Numbers: P.T.REC/012/004342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No