Effect of Exercise Intensity on Vitamin D

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Down Syndrome
• Intervention / Treatment: Other: High intensity treamill exercise training.; Other: Moderate intensity treamill exercise training.

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Mecca
    • Taif, Mecca, Saudi Arabia, 2425
      • College of Applied Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; GI received high-intensity exercise training.	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
Experimental: Group II; GII received moderate-intensity exercise training.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vitamin d after one month	serum level of 25(OH) D ng/ml after one month of intervention	one month
vitamin d after three months	serum level of 25(OH) D ng/ml after three months of intervention	three months
PTH after one month	Serum level of parathormone (PTH) pmol/L after one month of intervention	one month
PTH after three months	Serum level of parathormone (PTH) pmol/L after three months of intervention	three months

Collaborators and Investigators

• Sponsor: Taif University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 14, 2021

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Nutrition Disorders; Genetic Diseases, Inborn; Avitaminosis; Deficiency Diseases; Malnutrition; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Vitamin D Deficiency; Down Syndrome
• Other Study ID Numbers: 428

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