Protocol summary

Study aim
Determining the effect of the physical activity plan on the life quality of children aged 12-8 years with cystic fibrosis
Design
Single blind randomized clinical trial with intervention and control groups (children aged 8-12 who have had cystic fibrosis for 6 months)
Settings and conduct
Prior to the intervention, life quality questionnaire is divided between the control and intervention groups. In the intervention phase, the intervention group do physical activity. The control group does no activities.In the post-intervention phase, an evaluation will be performed from both intervention and control groups.
Participants/Inclusion and exclusion criteria
All children aged 8 to 12 years old with cystic fibrosis .Entry conditions 1) conscious willingness to participate in research 2) the recipient training has the ability to understand Persian language 3) the lack of children with acute and chronic mental and physical diseases other than کیستیک4 fibrosis) is the severity of the disease with the diagnosis of the physician at the moderate level and the ability to exercise 5) duration of minimum disease Six months and the conditions of non-entry to study age below 8 and above 12 and patients in the acute phase of disease and the ability to perform physical activity BASHDV the lack of concurrent disease with cystic fibrosis
Intervention groups
The subjects in the intervention group will receive, regularly according to their interest, aerobic physical exercises, like cycling, swimming, walking, dancing, playing with ball, rope skipping, jumping, as well as stretching guidelines for upper limbs, body and lower limbs (gymnastics) throughout four sessions of physical activity. However, the control group will not receive any training
Main outcome variables
Effective and principled training to reduce the complications of this disease and to enhance the life quality of the children with cystic fibrosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190407043190N1
Registration date: 2019-12-04, 1398/09/13
Registration timing: retrospective

Last update: 2019-12-04, 1398/09/13
Update count: 0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Kosar Tabatabaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3323 3813
Email address
skttmy70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-02, 1396/09/11
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
2017-12-02, 1396/09/11
Actual recruitment end date
2018-01-10, 1396/10/20
Trial completion date
2018-01-10, 1396/10/20
Scientific title
Determining the effect of the physical activity plan on the life quality of children aged 12-8 years with cystic fibrosis
Public title
effect of the physical activity plan on the quality of life in children with cystic fibrosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The informed willingness to participate in the study the learner should be able to understand Persian the child's non-suffering from acute and chronic psychological and physical illnesses except cystic fibrosis the severity of the disease should be moderate medically diagnosed by the physician and should have the ability to exercise duration of disease should be at least 6 months
Exclusion criteria:
Under 8 years and over 12 years The patient is not in an acute condition and is able to perform physical activity Absence of concomitant disease with cystic fibrosis
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is simple with the launch of a coin, which is 70 people in the study and how to allocate a und, which is divided into twelve groups of six in the intervention and control group.
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Khouzestan, iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-26, 1397/09/05
Ethics committee reference number
IR.AJUMS.REC.1397.632

Health conditions studied

1

Description of health condition studied
Cystic Fibrosis
ICD-10 code
E84.0
ICD-10 code description
Cystic fibrosis with pulmonary manifestations

Primary outcomes

1

Description
The effect of physical activity on the quality of life of children with cystic fibrosis based on quality of life questionnaire
Timepoint
Four weeks after the intervention
Method of measurement
Pediatric Quality Of Life Inventory TM

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group received eight to twelve years old children with cystic fibrosis. The intervention group is based on regular interest in aerobic exercise guidelines such as cycling, swimming, hiking, dancing, playing with balls, drawstring, jumbo as well as stretch limbs instructions Upper body, trunk and lower limbs (gymnastics) were trained for four sessions of physical activity during four weeks. People were told that they would be able to replicate the exercise exercises that they prefer during the week for 20 minutes. During the intervention, Pjohshgrbeh to strengthen aerobic exercises Farad the intervention group and their possible questions regarding these activities are contacted by phone calls or social networks and will receive a report of their activities.
Category
Rehabilitation

2

Description
In the control group, children with cystic fibrosis are eight to twelve years old and the control group will not be given any training and in order to appreciate them at the end of the manual intervention with a compact disc containing the animation of the training.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Ashraf al-sadat Hakim
Street address
Golestan Hospital, Farvardin St., Gelestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
golestanhospital@ajums.ac.ir

2

Recruitment center
Name of recruitment center
Aboozar hospital
Full name of responsible person
Ashraf al-sadat Hakim
Street address
Aboozar Hospital, Parastar(Tohid) Ave, Chahar shir Square
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3051
Email
aboozar-hos@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashraf al-sadat Hakim
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ashraf al-sadat Hakim
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
hakim3448200@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashraf al-sadat Hakim
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
hakim3448200@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashraf al-sadat Hakim
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
hakim3448200@yahoo.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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Changes in life quality due to physical activity will be released after making the individuals unidentifiable
When the data will become available and for how long
The beginning of the data access period is one year after the publication of the results.
To whom data/document is available
Data and other documentation are only available for use by researchers working in academic institutes
Under which criteria data/document could be used
The results of the study can be used to complete the studies of academic researchers on patients with cystic fibrosis
From where data/document is obtainable
One can contact Ms. Ashraf-Alsadat Hakim (cited in the Iranian Center for Clinical Trials) through various communication methods to access the results of the studies.
What processes are involved for a request to access data/document
Six months after the publication of the results, the applicants can request to use the data and documentation by communication channels specified in Iranian Registry of Clinical Trials, and at least three months after the date of the request, the request will be responded to appropriately.
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