Protocol summary

Summary
The aim of this study was to investigate the effects of twelve weeks regular aerobic exercises on serum levels of lipid profile, aerobic power and indices of body composition in non athletics women with mental retardation. Twenty-two women with mental retardation by 50 to 75 IQ percent who were randomly assigned into aerobic exercise training (n=10) and control group (n=12). The exercise protocol included aerobic (endurance) exercise training for 12 weeks and 3 sessions per week and every session lasted to 60 minutes and with intensity of 60-80 percent of heart rate reserve. Control group did not participate in any exercise training. Primary outcome measure was aerobic training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208068863N2
Registration date: 2012-09-15, 1391/06/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-15, 1391/06/25
Registrant information
Name
Keyvan Hejazi
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1768 6790
Email address
ke_he981@stu-mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Research, Ferdowsi University of Mashhad
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2009-10-23, 1388/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Twelve Weeks Regular Aerobic Exercises on Serum Levels of Lipid Profile, Aerobic Power and Indices of Body Composition in Non Athletics Women with Mental Retardation
Public title
The Effect of Exercise on Mental Retardation disease
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria: Female; Age: 20-28-year; Sedentary life style; Without significant weight reduction in recent six months. Exclusion criteria: Doing regular exercise during the last six months; Medical problem; Drug using
Age
From 20 years old to 28 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ferdowsi University of Mashhad
Street address
Physical Education Faculty, Ferdowsi University of Mashhad, Paradise Daneshgah, Azadi Square
City
Mashhad
Postal code
Approval date
2009-07-23, 1388/05/01
Ethics committee reference number
286311

2

Ethics committee
Name of ethics committee
Ferdowsi University of Mashhad
Street address
Physical Education Faculty, Ferdowsi University of Mashhad, Paradise Daneshgah, Azadi Square
City
Mashhad
Postal code
9177948979
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
286311

Health conditions studied

1

Description of health condition studied
Mentally retarded
ICD-10 code
F70-F79
ICD-10 code description
Mental retardation

Primary outcomes

1

Description
Weight
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
Kg

2

Description
Body Mass Index
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
Kg/M2

3

Description
WHR
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
Cm

4

Description
Body Fat Percent
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
%

5

Description
TG
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
mg/dL

6

Description
Chol
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
mg/dL

7

Description
HDL-C
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
mg/dL

8

Description
LDL-C
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
mg/dL

9

Description
VO2max
Timepoint
48 hours before exercise program and 48 hours after the last session after 3 months exercise
Method of measurement
ml.kg.min-1

Secondary outcomes

1

Description
Height
Timepoint
48 hours before exercise program and 48 hours after the last session after 3months exercise
Method of measurement
48 hours before exercise program and 48 hours after the last session after 3months exercise

Intervention groups

1

Description
The exercise protocol included aerobic (endurance) exercise training lasted to 3 months and 3 sessions per week and every session lasted to 60 minutes and with intensity of 60-80 percent of heart rate reserve
Category
Other

2

Description
control:Lack of exercise participation
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Centre for Girls Fath Almobyn
Full name of responsible person
keyvan Hejazi
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy Research Ferdowsi University of Mashhad
Full name of responsible person
Nahid Bijeh
Street address
Physical Education Faculty, Ferdowsi University of Mashhad, Paradise Daneshgah, Azadi Square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Research Ferdowsi University of Mashhad
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Physical Education Faculty, Ferdowsi University of Mashhad
Full name of responsible person
Dr.Nahid Bijeh
Position
Dr.
Other areas of specialty/work
Street address
Physical Education Faculty, Ferdowsi University of Mashhad, Paradise Daneshgah, Azadi Square
City
Mashhad
Postal code
4897991779
Phone
+98 51 1880 3468
Fax
+98 51 1882 9580
Email
Bijeh@ferdowsi.um.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Physical Education Faculty, Ferdowsi University of Mashhad
Full name of responsible person
Dr.Nahid Bijeh
Position
PhD, Physical Education Faculty, Ferdowsi University of Mashhad
Other areas of specialty/work
Street address
Physical Education Faculty, Ferdowsi University of Mashhad, Paradise Daneshgah, Azadi Square
City
Mashhad
Postal code
4897991779
Phone
+98 51 1880 3468
Fax
+98 51 1882 9580
Email
Bijeh@ferdowsi.um.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad, IRAN
Full name of responsible person
Dr.Nahid Bijeh
Position
PhD, Physical Education Faculty, Ferdowsi University of Mashhad
Other areas of specialty/work
Street address
Physical Education Faculty, Ferdowsi University of Mashhad, Paradise Daneshgah, Azadi Square
City
Mashhad
Postal code
4897991779
Phone
+98 51 1882 9580
Fax
+98 51 1882 9580
Email
Bijeh@ferdowsi.um.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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