Protocol summary
-
Study aim
-
Compare the effect of 12 weeks of resistance and combination exercise on some physiological variables in intellectually disabled children with overweight
-
Design
-
This research was an applied semi-experimental type and was performed in terms of data collection by field method with pre and post test measurement design. The statistical sample of the study consisted of 24 children of mentally retarded people of Isfahan city and it was done randomly and in parallel without blindness.
-
Settings and conduct
-
24 mentally retarded children were randomly divided into two groups of resistance and combination exercise. The training groups were active for 12 weeks, 3 sessions per week and 45 minutes per session.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: No other disease(cardiovascular disease); Non-placement in drug treatment courses; Training mental retardation with IQ Score of 35 to 50 and body mass index of 25 to 35; Male and female sex age 8 to 11 years.
Exclusion criteria: Children without educable mental disabilities; Less than 8 years and above 11 years; History of cardiovascular disease.
-
Intervention groups
-
Intervention Group 1: The 12 person group performed the strength training protocol.
Intervention Group 2: A group of 12 people performed a combined exercise (resistance؛ aerobic) protocol.
-
Main outcome variables
-
Aerobic capacity, body fat percentage, muscle strength an endurance, dynamic balance
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200326046861N1
Registration date:
2020-05-02, 1399/02/13
Registration timing:
retrospective
Last update:
2021-10-24, 1400/08/02
Update count:
1
-
Registration date
-
2020-05-02, 1399/02/13
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-09-23, 1398/07/01
-
Expected recruitment end date
-
2019-12-28, 1398/10/07
-
Actual recruitment start date
-
2019-09-23, 1398/07/01
-
Actual recruitment end date
-
2019-12-28, 1398/10/07
-
Trial completion date
-
2019-12-28, 1398/10/07
-
Scientific title
-
Comparison of resistance and concurrent training on physiological variables of intellectually disabled children with overweight
-
Public title
-
Comparison of resistance and concurrent training on physiological variables of intellectually disabled children
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Trainable mentally retarded
No other disease(cardiovascular disease)
Exclusion criteria:
Medical problems
drug use
-
Age
-
From 8 years old to 11 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
24
Actual sample size reached:
24
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
22 Intellectual disabillies children with overweight who were in our study area were divided into two equal groups of 12 peopel using a simple random sampling wethod(resistance training group and combined exercise group). the random sampling was such that the subjects were first ranked based on their body was index. In the second step is based on ABBA method. First, the person with the highest body mass index was in group A; the second and third person with the highest body mass index was in group B, and the fourth person( fourth rank) was in group A, and continued until the last one to be equal in accordance with the ABBA method.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-09-04, 1398/06/13
-
Ethics committee reference number
-
IR.UI.REC.1398.035
Health conditions studied
1
-
Description of health condition studied
-
of intellectually disabled children with overweight
-
ICD-10 code
-
F71
-
ICD-10 code description
-
Moderate intellectual disabilities
Primary outcomes
1
-
Description
-
Aerobic capacity
-
Timepoint
-
Before and 12 weeks after intervention
-
Method of measurement
-
20 m sweep test
2
-
Description
-
Dynamic balance
-
Timepoint
-
Before and 12 weeks after intervention
-
Method of measurement
-
Y balance test
3
-
Description
-
Body fat percentage
-
Timepoint
-
Before and 12 weeks after intervention
-
Method of measurement
-
Harbinger calipers
4
-
Description
-
Abdominal muscles endurance
-
Timepoint
-
Before and 12 weeks after intervention
-
Method of measurement
-
The long test of the Eifford meeting for one minute
5
-
Description
-
flexibility
-
Timepoint
-
Before and 12 weeks after intervention
-
Method of measurement
-
Sit and brush test
6
-
Description
-
Trunk Power
-
Timepoint
-
Before and 12 weeks after intervention
-
Method of measurement
-
Korea-made handheld and multifunction manometers with the mark SEHAN
Intervention groups
1
-
Description
-
Intervention Group 1: A 12-member group of resistance training protocol includes seven movements (step-by-step exercise, step-by-step exercise, squatting, long and sitting exercise, bridge on the ground, forearm dumbbell, dumbbell behind the arm) and up to 12 weeks And 3 days and This was done for 1 hour a week.
-
Category
-
Rehabilitation
2
-
Description
-
Intervention Group 2: A 12-person combined exercise protocol group was also performed for 12 weeks and 3 days per week for 1 hour. In the aerobic exercise section, the heart rate was adjusted to 50 to 80 percent of its maximum heart rate. Endurance training included brisk walking or running, and resistance training included strengthening the biceps, triceps, abdominal muscles of the back thigh muscles, and the front thigh muscles.
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Dr. Rasoul Roknizadeh
-
Proportion provided by this source
-
100
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
Because my information is personal
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available