Clincosm LogoSign in Get a demo

Resistive Exercise Versus HIIT on Calcium and Vitamin D

Sponsor
Cairo University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05795504
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
4.5
Anticipated Duration (Months)
13.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: resistive exercise
  • Other: high intensity interval training
  • Dietary Supplement: calcium and vitamin D
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Resistive Exercise Versus High Intensity Interval Training on Calcium and Vitamin D in Premenopausal Women: A Randomized Controlled Trial
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: resistive exercises

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

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.,

Dietary Supplement: calcium and vitamin D
they will receive calcium and vitamin D supplements only.
Active Comparator: conventional therapy

Dietary Supplement: calcium and vitamin D
they will receive calcium and vitamin D supplements only.

Outcome Measures

Primary Outcome Measures

  1. Vitamin D serum level [three months]

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

  2. serum calcium level [three months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of physical therapy Giza Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Mai shehata, Faculty of physical therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mai Mohamed Ali Shehata, lecturer of physical therapy for women's health, Cairo University
ClinicalTrials.gov Identifier:
NCT05795504
Other Study ID Numbers:
  • P.T.REC/012/004342
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamin D
Calcium

Study Results

No Results Posted as of Apr 3, 2023