- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06624657
High-intensity Interval Training and Vitamin D Effects on Bone Metabolism Among Women Diagnosed With Osteoporosis
December 26, 2024 updated by: Sami Gabr, King Saud University
Concurrent Effects of High-intensity Interval Training and Vitamin D Supplementation on Bone Metabolism Among Women Diagnosed With Osteoporosis
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
120
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control group
Participants are women with osteoporosis Characterized by normal daily activities and diets
|
subjects exercised by HIIT-exercise for 16 weeks
Other Names:
|
|
Exercise group
Participants are women's with osteoporosis participated in HIIT-exercise program interventions for 16 weeks
|
subjects exercised by HIIT-exercise for 16 weeks
Other Names:
|
|
Vitamin D group
Participants are women's with osteoporosis who received vitamin D 800IU/ day for 16 weeks
|
subjects exercised by HIIT-exercise for 16 weeks
Other Names:
|
|
Concurrent group
Participants are women's with osteoporosis who shared for HIIT exercise program plus vitamin D for 16 weeks
|
subjects exercised by HIIT-exercise for 16 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric measurements
Time Frame: 4 month
|
BMI measurements were evaluated
|
4 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessments of bone mineral density (BMD)
Time Frame: 4 month
|
Before and after training along with vitamin D supplements, BMD of the lumbar spine
|
4 month
|
|
Assessments of bone serum markers and vitamin 25(OH) D
Time Frame: 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.
|
4 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2016
Primary Completion (Actual)
March 30, 2017
Study Completion (Actual)
May 25, 2017
Study Registration Dates
First Submitted
September 29, 2024
First Submitted That Met QC Criteria
October 1, 2024
First Posted (Actual)
October 3, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 26, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRC-2016-028
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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