Effect of Exercise Intensity on Vitamin D

Sponsor

Taif University (Other)

Overall Status

Completed

CT.gov ID

NCT05024110

Collaborator

(none)

Enrollment

Location

Arms

3.6

Actual Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome Vitamin D Deficiency	Other: High intensity treamill exercise training. Other: Moderate intensity treamill exercise training.	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 25, 2021

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

May 14, 2021

Arms and Interventions

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

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.

Outcome Measures

Primary Outcome Measures

vitamin d after one month [one month]
serum level of 25(OH) D ng/ml after one month of intervention
vitamin d after three months [three months]
serum level of 25(OH) D ng/ml after three months of intervention
PTH after one month [one month]
Serum level of parathormone (PTH) pmol/L after one month of intervention
PTH after three months [three months]
Serum level of parathormone (PTH) pmol/L after three months of intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of applied medical sciences	Taif	Mecca	Saudi Arabia	2425

Sponsors and Collaborators

Taif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hatem Allam, Assistant Prof., Taif University

ClinicalTrials.gov Identifier:

NCT05024110

Other Study ID Numbers:

First Posted:

Aug 27, 2021

Last Update Posted:

Sep 1, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Down Syndrome

Vitamin D Deficiency

Syndrome

Study Results

No Results Posted as of Sep 1, 2021