High-intensity Interval Training and Vitamin D Effects on Bone Metabolism Among Women Diagnosed With Osteoporosis

Completed

• Conditions: Osteoporosis; Exercise Overtraining; Vitamin D 25-Hydroxylase Deficiency

• Registration Number: NCT06624657
• Lead Sponsor: King Saud University

Brief Summary

The effects of 16-week high-intensity interval training (HIIT) and vitamin D supplements on bone mineral density (BMD) in women with osteoporosis. The participants assigned for HITT exercise training with or without vitamin D supplements for 16 weeks, and the levels of serum bone parameters like, Osteocalcin (OC), Ca, and s-BAP were estimated in women with osteoporosis at baseline and after post-training interventions. In addition, the levels of Vitamin D were also identified in all women's accordingly.

Detailed Description

our study aimed to investigate the effects of 16-week high-intensity interval training (HIIT) and vitamin D supplements on bone mineral density (BMD) in women with osteoporosis. thus, Serum levels of 25-Hydroxy-vitamin D (OH-D), Osteocalcin (OC), Ca, and s-BAP were estimated in women with osteoporosis at baseline and after post-training interventions. One-hundred twenty sedentary women aged (30-50 years) were diagnosed with osteoporosis. Patients were classified into four groups, 30 patients in each group; Control group (normal daily activities); Exercise group (HIIT-exercise for 16 weeks); Vitamin D group (vitamin D 800IU/ day for 16 weeks), and Concurrent group (HIIT exercise plus vitamin D for 16 weeks). Anthropometric measurements, BMD, serum levels of vitamin 25-(OH) D, Osteocalcin, s-BAP, and calcium were estimated in all participants' pre- and post-exercise training.

Study Timeline

• Study Start: 2016-07-15
• Primary Completion: 2017-03-30
• Study Completion: 2017-05-25
• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• A healthy non-smoker premenopausal women's
• Age are 30-50 years old
• subjects who diagnosed with osteoporosis based on the clinical features of bone mineral density (BMD) measured from both lumbar spine L2 to L4, and from the right and left sides of the hip region by Dual Energy X-ray Absorptiometry (DEXA, UNIGAMMA PLUS AC 230V 50/60Hz 400w, USA) scan method.

Exclusion Criteria

• Women with; physical disability,
• abnormal hormonal levels
• severe disease complications such as chronic kidney and liver diseases,
• rheumatoid and osteoarthritis diseases
• significant overweight (BMI ≥25) and obesity (≥30 kg/m2) per recommended by the World Health Organization
• history of receiving calcium, multivitamin supplements, corticosteroids, anticonvulsants, and heparin which might affects up on the assessment of bone markers and BMD measurements were excluded from this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anthropometric measurements	4 month	BMI measurements were evaluated

Secondary Outcome Measures

Name	Time	Method
Assessments of bone mineral density (BMD)	4 month	Before and after training along with vitamin D supplements, BMD of the lumbar spine
Assessments of bone serum markers and vitamin 25(OH) D	4 month	Considering the fifth day of the female monthly period (8-10 hours fasting), blood samples were taken from all participants following overnight fasting and within 48 hours before starting the test and just following 16-week exercise training and receiving vitamin D supplements.