Clinical trial NCT06624657: High-intensity Interval Training and Vitamin D Effects on Bone Metabolism Among Women Diagnosed With Osteoporosis
Official title: Concurrent Effects of High-intensity Interval Training and Vitamin D Supplementation on Bone Metabolism Among Women Diagnosed With Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Exercise Overtraining
Vitamin D 25-Hydroxylase Deficiency
Keywords: Exercise training, BMD, osteoporosis, Vitamin D deficiency
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: a healthy, no-smoking premenopausal women aged (30-50) years old subjects who diagnosed with osteoporosis based on the clinical features and diagnosis evidence 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 were invited to participate in this study

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anthropometric measurements
timeFrame: 4 month
Secondary outcomes:
measure: Assessments of bone mineral density (BMD)
timeFrame: 4 month
measure: Assessments of bone serum markers and vitamin 25(OH) D
timeFrame: 4 month
Other outcomes:
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