Back to resultsResistive Exercise Versus HIIT on Calcium and Vitamin D
Primary Purpose
Vitamin D Deficiency, Calcium, Premenopause
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
resistive exercise
high intensity interval training
calcium and vitamin D
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin D Deficiency
Eligibility Criteria
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
Sites / Locations
- Faculty of physical therapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
resistive exercises
high intensity interval training
conventional therapy
Arm Description
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.
Premenopausal women in group B will receive high intensity interval training for three times per week in addition to calcium and vitamin D supplementations
Premenopausal women in group C will receive calcium and vitamin D supplementations only.
Outcomes
Primary Outcome Measures
Vitamin D serum level
a blood sample of each participant will be taken to measure serum vitamin D level before and after the study
serum calcium level
a blood sample will be taken from each participant to measure calcium level of each participant before and after the study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05795504
Brief Title
Resistive Exercise Versus HIIT on Calcium and Vitamin D
Official Title
Resistive Exercise Versus High Intensity Interval Training on Calcium and Vitamin D in Premenopausal Women: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Calcium, Premenopause
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
resistive exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
high intensity interval training
Arm Type
Experimental
Arm Description
Premenopausal women in group B will receive high intensity interval training for three times per week in addition to calcium and vitamin D supplementations
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
Premenopausal women in group C will receive calcium and vitamin D supplementations only.
Intervention Type
Other
Intervention Name(s)
resistive exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
high intensity interval training
Intervention Description
They will perform HIIT for three sessions/ week for 12 weeks, 30 minutes/ session in addition to calcium and vitamin D supplements.,
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium and vitamin D
Intervention Description
they will receive calcium and vitamin D supplements only.
Primary Outcome Measure Information:
Title
Vitamin D serum level
Description
a blood sample of each participant will be taken to measure serum vitamin D level before and after the study
Time Frame
three months
Title
serum calcium level
Description
a blood sample will be taken from each participant to measure calcium level of each participant before and after the study.
Time Frame
three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai shehata
Organizational Affiliation
faculty of physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Resistive Exercise Versus HIIT on Calcium and Vitamin D
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