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The Effect of High-Intensity Interval Training and Sleep Regulation on Immunoglobulin A, IL-6 And IL-1β, hs-CRP, Body Composition, Anaerobic Power, Neuromuscular Coordination and Sleep Quality of Adolescent Girls with Sleep Disorders

Protocol summary

Study aim
The effect of high-intensity interval training and sleep regulation and the combination of the two on some immune system indices (IgA, L-6 and IL-1β, hs-CRP, cortisol), physiological factors (body composition, anaerobic capacity, Neuromuscular coordination) and sleep quality of adolescent girls with sleep disorders.
Design
A randomized, one-blinded, controlled, semi-experimental with a parallel-group design of 80 adolescent females with sleep disorders. A lottery will be used for randomization.
Settings and conduct
This research is an applied quasi-experimental study and includes pre-test and post-test with 4 experimental groups in which the effect of independent variables of high-intensity interval training and sleep regulation and a combination of the two on some immune system indicators, physiological factors and sleep quality in girls 13 to 17 years with sleep disorders will be assessed. The site of the intervention and sports evaluations will be in the club and blood tests will be performed in a specialized laboratory. Collaborative researchers will be blind to pre-test and post-test evaluations and the statistical expert will be blind to how individuals are assigned to the groups.
Participants/Inclusion and exclusion criteria
1- Having sleep disorders using a Pittsburgh questionnaire that was measured by a psychologist. 2. No history of mental illness and hormonal disorders. 3. Do not use sleeping pills. 4- Regular menstrual cycle. 5- No special diet.
Intervention groups
Eighty female students with sleep disorders based on the Pittsburgh Sleep Disorders Questionnaire (score 11 and above), will be identified and selected by convenience sampling method and randomly divided into 4 groups of 20 participants including high-intensity interval training, Sleep Regulation, Combined and Control groups.
Main outcome variables
Some immune system indicators (IgA, IL-6 and IL-1β, hs-CRP, cortisol)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180503039517N12
Registration date: 2021-12-18, 1400/09/27
Registration timing: prospective

Last update: 2021-12-18, 1400/09/27
Update count: 0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
Soleyman Ansari Kolachahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2906
Email address
solomonansari@phd.iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-15, 1400/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of High-Intensity Interval Training and Sleep Regulation on Immunoglobulin A, IL-6 And IL-1β, hs-CRP, Body Composition, Anaerobic Power, Neuromuscular Coordination and Sleep Quality of Adolescent Girls with Sleep Disorders
Public title
High-intensity interval training and sleep regulation on inflammatory and physical fitness indicators in girls with sleep disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having sleep disorders Regular menstrual cycle No special diet
Exclusion criteria:
Use of sleeping drugs History of mental illness and hormonal disorders being absent for two frequent or 3 consecutive sessions in training program
Age
From 13 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
80 adolescent girls (who have been diagnosed with sleep disorders based on their medical history) will be selected from schools by available sampling methods. The names of the participants will be written on paper and divided into two experimental and control groups through a random lottery.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, responsible for collecting and processing the data, the type of intervention, and the participants in the research groups are unaware.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University-Rasht Branch
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.IAU.Rasht.REC.1400.026

Health conditions studied

1

Description of health condition studied
sleep disorders
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified

Primary outcomes

1

Description
Some immune system indicators (IgA, IL-6 and IL-1β, hs-CRP, cortisol)
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
Measurement of cytokines using special IL-6 and IL-1β Diaclone kits made in France will be used according to the manufacturer's instructions and ELISA method. hs-CRP will be measured with the kit of Pars-Azmon Company (made in Iran-Karaj) and by enzymatic method. IgA concentration will be measured by turbidometry method and using Pars-Azmon kit made in Iran.

Secondary outcomes

1

Description
Physiological factors (body composition, anaerobic capacity, neuromuscular coordination)
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
To measure body composition, subjects' BMI will be used by dividing weight by height squared (Kg /m2), for anaerobic powerو Wingate test and for neuromuscular coordinationو stick test will be utilized.

2

Description
sleep quality
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
The Pittsburgh Questionnaire will be used.

Intervention groups

1

Description
Intervention group1: high intensity interval training. High intensity interval training group will perform four weeks, three sessions a week, 3 sets of RAST protocol with 3 minutes rest between each set in the first week, to which one set will be added every week and finally in the fourth week will reach six sets. Each set consisted of 6*35-meter sprints with a 10-second break between each repetition. Training sessions will be conducted at morning. Polar heart rate monitor is used to control the intensity of training.
Category
Rehabilitation

2

Description
Intervention group: sleep regulation. Each participant will be given an individualized sleep schedule that sets the time for going to bed, turning off the lights, and waking up for each day. The average time spent going to bed, turning off the lights, and waking up each person reported in her bedroom will be used to calculate these.
Category
Lifestyle

3

Description
Intervention group: combined. The combined group will perform both high intensity interval training and sleep regulation interventions.
Category
Rehabilitation

4

Description
Control group: Participants in this group will not receive any intervention and will continue their daily routine as usual.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Child and Adolescent Psychology Clinic
Full name of responsible person
Soleyman Ansari
Street address
Third floor, Amer Building, Next to the Finance Department, The beginning of Rashtian Street, Jahad square
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3358 3940
Email
solomonansari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Seidavi
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 4075
Email
solomonansari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 4073
Email
solomonansari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 4073
Email
solomonansari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 4073
Email
solomonansari@yahoo.com

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
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
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