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Completed

NCT Number: NCT05024110

Effect of Exercise Intensity on Vitamin D

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High intensity treamill exercise training.

Other

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.

Other

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

Primary outcomes

  1. vitamin d after one month

    Time frame: one month

    serum level of 25(OH) D ng/ml after one month of intervention

  2. vitamin d after three months

    Time frame: three months

    serum level of 25(OH) D ng/ml after three months of intervention

  3. PTH after one month

    Time frame: one month

    Serum level of parathormone (PTH) pmol/L after one month of intervention

  4. PTH after three months

    Time frame: three months

    Serum level of parathormone (PTH) pmol/L after three months of intervention

Sponsors and collaborators

Lead sponsor

Taif University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2021
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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