Protocol summary

Summary
The aim of this study is evaluating the effect of aerobic exercise and strength training on respiratory capacity and motor competence in children with asthma. The participants in the study should have mild to moderate asthma and do not have a history of atopy or exercise. Acute asthmatic children and children with chronic illness or other acute illness whom consuming vitamin C and E supplements and Omega 3 in the last three months are not included in the study. Total of 60 children aged 6 to 11 years old enrolled in the Phase 3 clinical trial. They matched randomly in three athletic training groups including strength, aerobic and combination of them also with a control group. In this study Blinding won’t be done. These training groups will do exercise once in a week under the supervision of coach up to eight-weeks and twice a week training session will be done at home. Signs and symptoms of asthma and spirometry test will be done and questionnaire before and after exercise testing will be completed by the participants then the results were compared with each other after the end of training period at the end of 8 weeks

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062028546N1
Registration date: 2017-04-06, 1396/01/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-06, 1396/01/17
Registrant information
Name
seyedeh manijheh Arabi
Name of organization / entity
Ferdowsi unvercity of mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3621 1627
Email address
ma.arabi@um.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2016-07-10, 1395/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of strength, aerobic and compound training on respiratory function and motor proficiency of per pubertal asthmatic children
Public title
Effect of exercise training on respiratory and motor function of asthmatic children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosing mild to moderate asthma ; taking medicine ; no aggravation regarding their diseases; suffering from atopic ; no sport experience ; mentioning tendency and ability to exercise; All samples were under the supervision of a physician specialist and treated with the same medicine. Exclusion criteria: participating in a research intervention in the past 6 months; existency of a smoker in the family; other chronic diseases and taking medicine for curing the disease; acute disease in the past month; suffering from amputation or joint - muscle disorder that is unconducive to having physical activity; using supplements such as vitamins C and E as well as omega-3 in three months later.
Age
From 6 years old to 11 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical science
Street address
Daneshgah Street Qureshi building
City
Mashhad
Postal code
Approval date
2015-12-28, 1394/10/07
Ethics committee reference number
IR.MUMS.fm.REC.1394.375

Health conditions studied

1

Description of health condition studied
Asthma illness
ICD-10 code
J45.8
ICD-10 code description
Combination of conditions listed in J45.0 and J45.1

Primary outcomes

1

Description
Forced Expiratory Volume in One Second
Timepoint
Before experiment
Method of measurement
Spirometry

2

Description
Tidal volume
Timepoint
Before experiment
Method of measurement
Spirometry

Secondary outcomes

1

Description
Oxygen consumption
Timepoint
Two month after intervention
Method of measurement
Spirometry

2

Description
Carbon dioxide production
Timepoint
Two month after interention
Method of measurement
Spirometry

3

Description
Tidal volume
Timepoint
Two month after interention
Method of measurement
Spirometry

4

Description
The number of Breathe
Timepoint
Two month after interention
Method of measurement
Spirometry

5

Description
Minute ventilation
Timepoint
Two month after interention
Method of measurement
Spirometry

6

Description
Respiratory rate
Timepoint
Two month after intervention
Method of measurement
Spirometry

Intervention groups

1

Description
Intervention group 1: Power sports for 8 weeks
Category
Rehabilitation

2

Description
Intervention group 2: Endurance sports for 8 weeks
Category
Rehabilitation

3

Description
Intervention group 3: Compound sport (power and endurance for 8 weeks
Category
Rehabilitation

4

Description
Control group: Without any sports
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Hamid Ahanchian
Street address
Allergy Clinic Ghaem Hospital, Ahmad Abad Street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Qureshi building, Daneshgah Street, Mashhad
City
Mashhad
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, Mashhad 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
Ferdowsi university of Mashahad
Full name of responsible person
Manijheh Arabi
Position
Phd student of motor development
Other areas of specialty/work
Street address
Paradise of Ferdowsi university. Azadi square
City
Mashhad
Postal code
Phone
+98 51 3768 6638
Fax
Email
ma.arabi@um.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ezzat Khodashenas
Position
Specialist of Pediatrician
Other areas of specialty/work
Street address
Department of Pediatrics, Ghaem Hospital, Ahmad Abad street
City
Mashhad
Postal code
394491388
Phone
+98 51 3841 3006
Fax
Email
khodashenase@mums.ac.ir ; ARC@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Vahideh Velayati
Position
Ph.D. student of motor development
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
+98 51 3768 6638
Fax
Email
Velayati.v@gmail.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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