Effect of Exercise Intensity on Vitamin D

August 30, 2021 updated by: Hatem Allam, Taif University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
vitamin d after one month
Time Frame: one month
serum level of 25(OH) D ng/ml after one month of intervention
one month
vitamin d after three months
Time Frame: three months
serum level of 25(OH) D ng/ml after three months of intervention
three months
PTH after one month
Time Frame: one month
Serum level of parathormone (PTH) pmol/L after one month of intervention
one month
PTH after three months
Time Frame: three months
Serum level of parathormone (PTH) pmol/L after three months of intervention
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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