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Effect of Exercise Intensity on Vitamin D

Primary Purpose

Down Syndrome, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
High intensity treamill exercise training.
Moderate intensity treamill exercise training.
Sponsored by
Taif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome

Eligibility Criteria

8 Years - 12 Years (Child)MaleDoes not accept 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.

Sites / Locations

  • College of applied medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I

Group II

Arm Description

GI received high-intensity exercise training.

GII received moderate-intensity exercise training.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2021
Last Updated
August 30, 2021
Sponsor
Taif University
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1. Study Identification

Unique Protocol Identification Number
NCT05024110
Brief Title
Effect of Exercise Intensity on Vitamin D
Official Title
Response of Vitamin D and Parathormone to Different Exercise Intensities in Children With Down's Syndrome: a Clinical Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
GI received high-intensity exercise training.
Arm Title
Group II
Arm Type
Experimental
Arm Description
GII received moderate-intensity exercise training.
Intervention Type
Other
Intervention Name(s)
High intensity treamill exercise training.
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Moderate intensity treamill exercise training.
Intervention Description
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 Outcome Measure Information:
Title
vitamin d after one month
Description
serum level of 25(OH) D ng/ml after one month of intervention
Time Frame
one month
Title
vitamin d after three months
Description
serum level of 25(OH) D ng/ml after three months of intervention
Time Frame
three months
Title
PTH after one month
Description
Serum level of parathormone (PTH) pmol/L after one month of intervention
Time Frame
one month
Title
PTH after three months
Description
Serum level of parathormone (PTH) pmol/L after three months of intervention
Time Frame
three months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
All children were male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
College of applied medical sciences
City
Taif
State/Province
Mecca
ZIP/Postal Code
2425
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Exercise Intensity on Vitamin D

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