Determining the effect of exercise training on sleep habits in children with type 1 diabetes
Design
This study includes 62 children with type 1 diabetes who are randomly divided into two control and intervention groups.
Settings and conduct
Children with type 1 diabetes who refer to hospitals affiliated to Kermanshah University of Medical Sciences during the study will be included in the study if they are eligible. Therefore, they will be randomly assigned to the intervention and control groups using the random block method.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children who are in the age range of 6 to 12 years,
Children who have a history of diabetes for one year,
Children whose parents live in Kermanshah,
Children who do not have a specific mental or cognitive illness,
Children who do not have musculoskeletal diseases,
Children who have not participated in another diabetes education program in the past month.
Exclusion criteria:
Children who have concurrent diseases such as kidney diseases,
Children who use drugs that affect blood sugar,
Children who are resistant to autoimmune diseases affecting insulin.
Children who are active in a particular sport.
Intervention groups
Intervention group: The intervention includes the implementation of sports exercises based on sports instructions. The exercise training protocol (warming up, brisk walking, and cooling down) consists of eight weeks of training. There are 3 training sessions per week and each session includes 30 minutes of training. After the intervention, the sleep habits questionnaire will be completed by the parents. Control group: This group will have daily and routine walks.
Investigating the effect of sports training on the quality and quantity of sleep in children aged 6 to 12 years with type 1 diabetes
Public title
The effect of exercise training on the quality and quantity of sleep in children with diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children who are in the age range of 6 to 12 years.
Children who have a history of diabetes for one year.
Children whose parents live in Kermanshah.
Children who do not have a specific mental or cognitive illness.
Children who do not have musculoskeletal diseases.
Children who have not participated in another diabetes education program in the past month.
Exclusion criteria:
Children who have concurrent diseases such as kidney diseases
Children who use drugs that affect blood sugar, such as Corticosteroids
Children who are resistant to autoimmune diseases affecting insulin.
Children who are active in a particular sport
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are calculated using G*power sample size calculation software. Considering the effect size of 0.871, alpha value of 0.05, and test power of 0.90, 62 people are included in the study. The samples will be randomly divided into two control and intervention groups (blocks with a size of four). Random allocation software is used for randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study included two experimental and control groups. The intervention for the experimental group consisted of 8 weeks of regular exercise program. There is no intervention for the control group. The group will carry out its usual routine.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences., Anoshiravan Rezaei Square., Moalem Ave
City
Khorramabad
Province
Lorestan
Postal code
6183833946
Approval date
2022-10-19, 1401/07/27
Ethics committee reference number
IR.LUMS.REC.1401.174
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Sleep Habits Score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
2
Description
Bedtime Resistance score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
3
Description
Sleep Onset Delay score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
4
Description
Sleep Duration score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
5
Description
Sleep Anxiety score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
6
Description
Night Wakings score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
7
Description
Parasomnias score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
8
Description
Sleep Disordered Breathing score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
9
Description
Daytime Sleepiness score
Timepoint
before the intervention and 8 weeks after the intervention
Method of measurement
Children’s Sleep Habits Questionnaire (CSHQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention includes the implementation of sports exercises based on sports instructions. The video of these exercises will be sent to parents using virtual social networks (Eta, Rubika, Shad). The exercise training protocol (warming up, brisk walking, and cooling down) consists of eight weeks of training. There are 3 training sessions per week and each session includes 30 minutes of training. After the intervention, the sleep habits questionnaire will be completed by the parents.
Category
Lifestyle
2
Description
Control group: This group will have daily and routine walks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Clinic
Full name of responsible person
Kimia Karami
Street address
Mohammad Kermanshahi Clinic., Red Crescent Square., Mosavari Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
MKH@kums.ac.ir
2
Recruitment center
Name of recruitment center
Taleghani educational and therapeutic center
Full name of responsible person
Kimia Karami
Street address
Taleghani educational and therapeutic center., Naft Square., Shahid Beheshti Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Fax
+98 83 3835 8754
Email
taleghani_hospital@yhoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Bahram Rasolian
Street address
Lorestan University of Medical Sciences., Anoshiravan Rezaei Square., Moalem Ave
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
Rasolian.Bahram@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kimia Karami
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Lorestan University of Medical Sciences., Anoshiravan Rezaei Square., Moalem Ave
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Fax
Email
pr@lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kimia Karami
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Lorestan University of Medical Sciences., Anoshiravan Rezaei Square., Moalem Ave
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
pr@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Kimia Karami
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Lorestan University of Medical Sciences., Anoshiravan Rezaei Square., Moalem Ave
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
0986633300661
Email
pr@lums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available