Effect of Exercise Intensity on Vitamin D

NCT05024110 | Completed

• 1 other identifier: 428
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Down Syndrome; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group I

EXPERIMENTAL

GI received high-intensity exercise training.

Other: High intensity treamill exercise training.

Group II

EXPERIMENTAL

GII received moderate-intensity exercise training.

Other: Moderate intensity treamill exercise training.

Interventions

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

Group I

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

Group II

Eligibility Criteria

• Age: 8 Years - 12 Years
• Gender Eligibility Details: All children were male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taif University: lead

Study Sites (1)

College of applied medical sciences

Ta'if, Mecca Region, 2425, Saudi Arabia

Location

MeSH Terms

Conditions

Down Syndrome; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Model Details: A randomized controlled trial was used to investigate the effect of exercise intensity on vitamin D and PTH levels in children with Down's syndrome. The enrollment of the participants was done by telephone calls to their parents or legal guardians. A total of fifty male DS subjects were initially selected to participate in the study. Only forty-four subjects completed the interventional study because six children were excluded. three children did not meet the inclusion criteria, parents of two children refused to complete the study, and one lost to follow-up. Their age was ranged from 8-12 years. The participants were assigned randomly using sealed envelopes into two equal groups; group I (GI) and group II (GII) each contain twenty-two subjects. GI received the high-intensity T-AE and the GII received the moderate-intensity T-AE, three times per week for three months. All subjects were selected from hospitals in the Western area, Saudi Arabia.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: January 25, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 14, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)