Evaluation of changes in weight, body mass index, cortisol level and mental health (anxiety, depression and aggression) after 12 weeks of combined exercise and 4 weeks of detraining
Design
Clinical trial with control group, parallel, non-blind, randomised,
Settings and conduct
The 12-weeks intervention in exercise group involved a physical activity program with 3 60-min sessions/week consisted of 30 min of aerobic exercise with an intensity of 55% to 65% of individual maximal cardio-respiratory fitness followed by 20 min of strengthening exercises and 10 min of stretching and cool-down Which is done by two experienced coaches in the sports hall of the civil town of Hamedan. Sampling and Measurement of questionnaire factors is done before the start of the exercise protocol, after 12 weeks of exercise and after 4 weeks of detraining.
Participants/Inclusion and exclusion criteria
The inclusion criteria: 1. Girls with central precocious puberty; 2. Having a BMI higher than 19; 3.The age range of 7 to 9 years; The exclusion criteria: 1. having another illness; 2. Use of any medication other than Differlin ; 3. having a special diet (Vegetarianism,...); 4. being active in another sport.
Intervention groups
1- Intervention group: 22 overweight and obese girls with precocious puberty who receive Differlin every 28 days as an intramuscular injection and perform combined exercise (resistance + aerobic) for 12 weeks
2 - Control group: 22 overweight and obese girls with precocious puberty who receive Differlin only intramuscular injection every 28 days
Main outcome variables
Weight, body mass index, cortisol, anxiety, depression, aggression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170411033378N10
Registration date:2022-02-27, 1400/12/08
Registration timing:prospective
Last update:2022-02-27, 1400/12/08
Update count:0
Registration date
2022-02-27, 1400/12/08
Registrant information
Name
Efat Sadeghian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
sadeghian_e@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise training and detraining on cortisol level and mental health of over weight and obese girls with precocious puberty
Public title
The effects of exercise on mental health of obese girls with precocious puberty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Girls with central precocious puberty
Having a BMI higher than 19
The age range of 7 to 9 years
One year has passed since they were diagnosed with precocious puberty
Being treated with Differlin drug
Taking medication 1 ml every 28 days
Exclusion criteria:
having another illness
taking another medicine
having a special diet (Vegetarianism, ...)
being active in another sport
being connected to drugs
Age
From 7 years old to 9 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block method, the size of blocks is equal to 6 with two members in a ratio of 1: 1. Using the site www.sealedenvelope.com, a random sequence of 6 blocks with two members Control and Treatment is determined, then the sequence of intervention and control groups in different envelopes from number 1 to the sample size is considered. Upon arrival of each eligible volunteer, one of the envelopes is opened and its treatment group is determined.
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
Research Ethics Committees of Hamadan University of Medical Scieneces
Street address
Shahid Fahmideh St., in front of the People's Park of Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2022-01-26, 1400/11/06
Ethics committee reference number
IR.UMSHA.REC.1400.883
Health conditions studied
1
Description of health condition studied
Precocious puberty
ICD-10 code
E30.1
ICD-10 code description
Precocious puberty
Primary outcomes
1
Description
Cortisol
Timepoint
Baseline, 12 weeks, 16 weeks
Method of measurement
Blood sampling and use of laboratory kits Elisa method
2
Description
Weight and body mass index
Timepoint
Baseline, 12 weeks, 16 weeks
Method of measurement
Digital scale, standard height meter
3
Description
anxiety
Timepoint
Baseline, 12 weeks, 16 weeks
Method of measurement
Spence Children Anxiety Scale
4
Description
depression
Timepoint
Baseline, 12 weeks, 16 weeks
Method of measurement
Self-rating Depression Scale
5
Description
aggression
Timepoint
Baseline, 12 weeks, 16 weeks
Method of measurement
Nelson Child Aggression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention used is a combination training protocol (aerobic + resistance) for 12 weeks, 3 sessions per week and each session will be 60 minutes of aerobic + resistance training in which 30 minutes of aerobic exercise including walking, running, ball games With 55 to 65% of heart rate and 20 minutes of resistance training in the arms, legs and trunk in 2 or 3 sets of 10 to 15, which will be done through body weight or elastic bands, and at the end of each session, cool down for 10 minutes and we will return to the original state.
Category
Rehabilitation
2
Description
Control group:Does not receive intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Dr.Efat Sadeghian
Street address
Shahid Fahmideh Blvd, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Fax
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Street address
Shahid Fahmeideh bulvar, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefta@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Bulvar, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
IPD briefly describe what specific participant data sets are to be shared
When the data will become available and for how long
starting in َJuly 2022
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
people working in academic institutions
From where data/document is obtainable
Efat Sadeghian
via Email: sadeghianefat@gmail.com
What processes are involved for a request to access data/document