Protocol summary

Summary
The current study is of clinical trial one aiming to examine the impact of the combination training course (core stability, endurance) on deaf students’ physical stamina. The inclusion criteria: age of 15-18; hearing range of more than 75 db and avoidance of medicines that affect balance during research procedure. The exclusion criteria: avoidance of participating in the relevant sessions and not completing the length of training period; cardiovascular and respiratory diseases. 24 deaf students are randomly divided into 2 equal groups in number: experimental and control. The first group, after preliminary assessments of both groups, will be given an 8-week combination-training course (core stability and endurance). In order to assess those factors involved in the physical stamina, the function tests of physical fitness will be used. Both groups will be assessed again after 8 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031233029N1
Registration date: 2017-10-20, 1396/07/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-20, 1396/07/28
Registrant information
Name
Hamed Zarei
Name of organization / entity
University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 81 3536 3540
Email address
zareei.hamed71@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-04-06, 1395/01/18
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a combined training program (Core stability and Endurance) on physical fitness factors of deaf students
Public title
The effect of exercise on executive functions of deaf students
Purpose
Supportive
Inclusion/Exclusion criteria
According that the subjects are deaf, Inclusion criteria: The inclination of participation in the research; the refraining of tranquilizers or those with effects on balance; the Lack of cochlear implantation; the hearing range of more than 75 db; avoidance of exercising or any intense activities during the research; no lower limb damage background during the past 6 months or any neural or muscular complexities; no eyesight disorder; lack of any status abnormalities effective in the procedure of the research (in the lower and upper limbs); not surgical background in the past year; not a fracture in the upper and lower limbs a year prior to research. Exclusion criteria: Lack of participation in two sequential practice sessions or in three interrupted practice sessions; the advent of Musculoskeletal pain after practice; students suffering from multiple disabilities; cardiovascular and respiratory diseases; articular system and orthopedic disorders including neck pain, backache, rheumatoid arthritis or the apparent difference in the length of the limbs
Age
From 15 years old to 18 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Subjects were divided into experimental and control groups based on Sealed envelopes.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Tehran Province, Tehran, Zone 7,Impasse V
City
Tehran
Postal code
Approval date
2016-04-03, 1395/01/15
Ethics committee reference number
IR. SSRI. REC. 1396. 131

Health conditions studied

1

Description of health condition studied
Fitness
ICD-10 code
Z02.5
ICD-10 code description
General medical examination

Primary outcomes

1

Description
Balance
Timepoint
Before intervention and 2 months after intervention
Method of measurement
BESS Test and Y test

2

Description
Abdominal muscle endurance
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Sit-up test

3

Description
Aerobic endurance
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Step test

4

Description
Back extensor muscle endurance
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Sorensen test

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
The combined training group will attend training sessions, including core stability, muscular endurance and aerobic endurance training for 8 weeks, and their status will be evaluated before and two months after the intervention.
Category
Rehabilitation

2

Description
There is no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghcheban Deaf School
Full name of responsible person
Hamed Zarei
Street address
Tarbiat Moallem University side , Tarbiat Moallem Square, Guilan Blvd Rasht city
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Hamed Zarei
Street address
Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Guilan University of Medical Sciences
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
University of Guilan
Full name of responsible person
Hamed Zarei
Position
Postgradute
Other areas of specialty/work
Street address
Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road
City
Rasht
Postal code
Phone
+93 95995280
Fax
Email
zareei.h@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Hamed Zarei
Position
Postgraduate
Other areas of specialty/work
Street address
Faculty of Physical Education, University of Guilan, Km 12 Rasht-Ghazvin Road
City
Rasht
Postal code
Phone
+93 95995280
Fax
Email
zareei.h@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Hamed Zarei
Position
Postgraduate
Other areas of specialty/work
Street address
Faculty of Physical Educations, University of Guilan, Km 12 Rasht-Ghazvin Road
City
Rasht
Postal code
Phone
+93 95995280
Fax
Email
zareei.h@yahoo.com
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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