Effect of Exercise Intensity on Vitamin D

Vitamin D Deficiency Clinical Trial

Official title:

Response of Vitamin D and Parathormone to Different Exercise Intensities in Children With Down's Syndrome: a Clinical Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05024110
• Other study ID #: 428
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: May 14, 2021

Study information

• Verified date: August 2021
• Source: Taif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children with Down's syndrome (DS) are more liable to vitamin D deficiency. Treating this deficiency with supplements is associated with the risk of intoxication due to increased intestinal absorption or decreased vitamin D metabolism. The aim of the study was to compare the effect of two exercise intensities on the modulation of vitamin D and Parathormone (PTH) levels in children with DS.

Description:

Forty-four DS male children aged from 8-12 years participated in the study. The subjects were assigned randomly into two equal groups. group I received high-intensity treadmill aerobic exercises (T-AE) and group II received moderate-intensity T-AE, three times per week for three months. the blood samples were collected from both groups before the intervention, after one month of intervention, then after three months of intervention to assess serum 25(OH)D and PTH levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 14, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• all subjects were trainable and able to walk freely without assistance.
• Had vitamin D deficiency, the serum level of 25-hydroxyvitamin D (25(OH) D) was ranged from 10-20ng/mL.
• Did not take calcium or vitamin D3 supplements, medications for osteoporosis, antiepileptic drugs, or any medications that may affect the vitamin D metabolism in the last 5 months.
• The feeding method during the first two years of age for all children was bottle feeding.
• Mild to moderate mentally retarded, (IQ ranged from 45-70) to be able to understand and obey simple orders.
• free from any medical consequences for example cardiopulmonary disorders, auditory defects, and visual impairments.
• Had no previous history of strength training.
• Body mass index percentile ranged from the 50th percentile to less than the 75th percentile (healthy).
• The feeding method was by mouth with no special diet, with an absence of signs of malnutrition

Exclusion Criteria:

• autoimmune disease.
• Renal diseases.
• Have taken any thyroid medications.
• Obesity.
• epileptic fits.

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome
• Vitamin D Deficiency

Intervention

Other:
• High intensity treamill exercise training.
We used the Martti Karvonen formula to calculate the heart rate zone. Firstly, the resting heart rate (rest-HR) was detected for every participant by inviting him to lie in a prone position for 10 minutes while catching a heart rate monitor. After that, the maximum heart rate (max-HR) was calculated by utilizing this formula: maximum heart rate =220- age. Then, we calculated the heart rate reserve (HRR) by using the law: HRR= max-HR - resting HR. Exercise intensity is represented as a percentage of HRR. Finally, the target heart rate (target-HR) was calculated by using the formula: target-HR = HRR x intensity% + rest-HR. Moderate-intensity exercises are defined as the activity which uses 50% to 70% of the HRR, while high-intensity exercises use 70% to 90% of the HRR
• Moderate intensity treamill exercise training.
We used the Martti Karvonen formula to calculate the heart rate zone. Firstly, the resting heart rate (rest-HR) was detected for every participant by inviting him to lie in a prone position for 10 minutes while catching a heart rate monitor. After that, the maximum heart rate (max-HR) was calculated by utilizing this formula: maximum heart rate =220- age. Then, we calculated the heart rate reserve (HRR) by using the law: HRR= max-HR - resting HR. Exercise intensity is represented as a percentage of HRR. Finally, the target heart rate (target-HR) was calculated by using the formula: target-HR = HRR x intensity% + rest-HR. Moderate-intensity exercises are defined as the activity which uses 50% to 70% of the HRR, while high-intensity exercises use 70% to 90% of the HRR

Locations

Country	Name	City	State
Saudi Arabia	College of applied medical sciences	Taif	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Taif University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin d after one month	serum level of 25(OH) D ng/ml after one month of intervention	one month
Primary	vitamin d after three months	serum level of 25(OH) D ng/ml after three months of intervention	three months
Primary	PTH after one month	Serum level of parathormone (PTH) pmol/L after one month of intervention	one month
Primary	PTH after three months	Serum level of parathormone (PTH) pmol/L after three months of intervention	three months