Protocol summary

Study aim
Asthma is a chronic disease that causes morbidity and reduced quality of life. People with asthma are less active than their peers, leads the patient to become more and more sedentary. Asthma can cause postural changes in the spine, shoulder girdle, which is a good option to prevent and correct these changes. For the prevention and correction of these changes, the use of corrective exercises and breathing can be a good choice. Therefore, the aim of this study was to investigate The effect of combined respiratory and corrective training on angle of kyphosis and respiratory capacity indices in children with asthma.
Design
Clinical trial with control group
Settings and conduct
Children with asthma referred to Hafdeh Shahrivar Hospital in Rasht were identified by a pulmonologist with mild asthma according to the inclusion and exclusion criteria. Samples were randomly divided into two groups of 15 experimental subjects (combined corrective and respiratory exercises and conventional therapy) and the control group (conventional therapy). The experimental group performed selected corrective and respiratory exercises for eight weeks, three sessions per week and 30 to 45 minutes per session
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 8 to 14 years, mild asthma and the desire of the subject and parents to participate in the study Exit condition: Older and younger ages, severe or moderate asthma, severe asthma attacks and scoliosis and orthopedic problems, unwillingness of the child or parents to participate in the study
Intervention groups
Experimental group: The training protocol receives corrective and respiratory movements Control group: They will not have any regular and regular exercise and only the usual treatment
Main outcome variables
Evaluation of dorsal spinal curvature (kyphosis)؛respiratory capacity (FEV1, FEV1 / FVC)؛ anthropometric indices chest

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160815029373N6
Registration date: 2020-12-19, 1399/09/29
Registration timing: prospective

Last update: 2020-12-19, 1399/09/29
Update count: 0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Parisa Sedaghati
Name of organization / entity
Guilan University
Country
Iran (Islamic Republic of)
Phone
+98 21 4423 7480
Email address
sedaghati@guilan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a course of combined respiratory and corrective exercises on pulmonary function and chest Anthropometrie index in children with asthma
Public title
The effect of breathing exercises on pulmonary function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 8 and 14 yearst Mild asthma Desiring of the subject and parents to participate in the study
Exclusion criteria:
Older and younger ages Severe or moderate asthma Severe asthma attacks Scoliosis orthopedic problems
Age
From 8 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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 Guilan University of Medical Sciences
Street address
8 km of Qazvin-Rasht road, Faculty of Physical Education and Sports Sciences, University of Guilan
City
Rasht
Province
Guilan
Postal code
4199843653
Approval date
2020-02-21, 1398/12/02
Ethics committee reference number
IR.GUMS.REC.1393.537

Health conditions studied

1

Description of health condition studied
Asthmatic patients
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Angle of kyphosis
Timepoint
The beginning of the study and eight weeks later
Method of measurement
Flexible ruler

2

Description
Respiratory capacity
Timepoint
The beginning of the study and eight weeks later
Method of measurement
Spirometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: performing corrective and breathing exercises protocol with common treatment
Category
Rehabilitation

2

Description
Control group: protocol with common treatment
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
17 Shahrivar Hospital, Rasht
Full name of responsible person
Seyedeh Zahra Mirshafiei
Street address
Shahid Siadati Square, Rasht, Gilan Province
City
Rasht
Province
Guilan
Postal code
5437941446
Phone
+98 13 3336 9391
Email
17shahrivar@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Guilan
Full name of responsible person
Farhad Rahmaninia
Street address
8 km of Qazvin-Rasht road, Faculty of Physical Education and Sports Sciences, University of Guilan, Rasht
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0276
Email
university@guilan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Guilan
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Seyedeh Zahra Mirshafiei
Position
Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
8 km of Qazvin-Rasht road, Faculty of Physical Education and Sports Sciences, University of Guilan, Rasht
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0274
Email
sedaghati@guilan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Seyedeh Zahra Mirshafiei
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercise
Street address
8 km of Qazvin-Rasht road, Faculty of Physical Education and Sports Sciences, University of Guilan, Rasht
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0274
Email
sedaghati@guilan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Seyedeh Zahra Mirshafiei
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercise
Street address
8 km of Qazvin-Rasht road, Faculty of Physical Education and Sports Sciences, University of Guilan, Rasht
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0274
Email
sedaghati@guilan.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
اطلاعات بیشتری وجود ندارد
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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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