Protocol summary

Study aim
Determine the effect of breathing pattern correction training based on Buteyko's theory on capnometric indices in hyperkyphotic women
Design
two arm parallel groups, randomised clinical trial with control group, single blinded
Settings and conduct
In the intervention group, in addition to kyphosis correction exercises, breathing pattern correction exercises derived from the Buteyko theory are performed in the form of a home exercise. Before and after the end of interventions in both groups, copnometric indices will be measured in the laboratory of the Ahwaz rehabilitation faculty. This study will be single blinded . So that the evaluator and the individual who teaches the training are different and the evaluator will not be aware of the grouping of the samples.
Participants/Inclusion and exclusion criteria
inclusion : women 18 to 30 years old, thoracic kyphosis angle 40 degrees or more exclusion: scoliosis , structural kyphosis , spine fractures in the past , shoulder fracture in the past six months , diseases that prevent the person from participating in sport activities , chronic breathing diseases
Intervention groups
Intervention group: Perform kyphosis correction exercises including stretching and strengthening exercises and breathing pattern correction exercises based on the Buteyko,s theory at home, three sessions a week for eight weeks. duration of each session: 60 minutes Control group: Perform kyphosis correction exercises at home, including stretching and strengthening exercises, three sessions a week for eight weeks. duration of each session: 45 minutes
Main outcome variables
end tidal co2؛ respiration rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190114042351N1
Registration date: 2019-05-05, 1398/02/15
Registration timing: registered_while_recruiting

Last update: 2019-05-05, 1398/02/15
Update count: 0
Registration date
2019-05-05, 1398/02/15
Registrant information
Name
Majid Ravanbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 5160
Email address
majidravanbakhsh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-18, 1398/01/29
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breathing pattern correction training based on Buteyko's theory on capnometric indices in hyperkyphotic women- A randomised clinical trial
Public title
The effect of breathing pattern correction training on capnometric indices in hyperkyphotic women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women 18 to 30 years old with 40 degree or more thoracic kyphosis angle( determined by flexible ruler)
Exclusion criteria:
scoliosis deformity structural thoracic kyphosis according to specialist physician diagnosis past history of spinal fracture history of shoulder fracture in the past 6 months having diseases that interfere with sport exercises(such as: uncontrolled blood pressure,diabetes type1, angina, acute cardiac diseases) past history of any chronic respiratory disease according to patients statement
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individuals are randomly divided into two groups based on the permuted block randomization method with block size of 4 .The block size of 4 have 6 types (probabilities), that we set for each type a number from 1 to 6. In order to form a random sequence, we use random allocation software. individuals who enter the study are assigned to two groups based on the sequence of the letters generated by this method. randomization unit is individual. allocation concealment is done by using random sequence, sealed, opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
A person evaluate the participants and another person teaches the exercises
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondi shapour University of Medical Sciences
Street address
Ahvaz Jondi Shapour University, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
4331385617
Approval date
2019-01-13, 1397/10/23
Ethics committee reference number
IR.AJUMS.REC.1397.754

Health conditions studied

1

Description of health condition studied
Thoracic hyperkyphosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
end tidal co2
Timepoint
before starting the intervention and 8 weeks after persistant implementation of the intervention
Method of measurement
by viamed capnograph

2

Description
respiration rate
Timepoint
before starting the intervention and 8 weeks after persistant implementation of the intervention
Method of measurement
by viamed capnograph

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, in addition to the control group exercises, which include common hyperkyphosis correction exercises, the breathing pattern correction exercises derived from the Buteykos theory, including: diaphragmatic breathing, slow and deep breathing and hold breath technique are also performed on a day-to-day basis for 8 weeks. Kyphosis correction exercises include stretching exercises for short muscles in the anterior of the chest and strengthening exercises for the muscles in the posterior of the chest wall. In stretching exercises, stretching is maintained for 30 seconds. In strengthening exercises, the muscle contraction is held for 10 seconds, then returns to its original state and rest for 10 seconds and then resumes the movement. Each of the stretching and strengthening exercises is repeated 10 times in each session. In each session, all respiratory techniques used to increase the depth and reduce the respiratory rate, are done each for 5 minutes.In each session, the duration of the kyphosis correction exercises, which are common in two groups, is 45 minutes and the breathing pattern correction exercises that are specific to the intervention group is 15 minutes.
Category
Rehabilitation

2

Description
Control group: routine thoracic hyperkyphosis correction exercise for eight weeks(3 times per week)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
laboratory of rehabilitation faculty of Ahvaz
Full name of responsible person
Vedad Abdolkhani
Street address
Rehabilitation Sciences faculty, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
4331385617
Phone
+98 61 3333 9087
Email
abdolkhanivedad@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Association center of Research and Technology of Jundishapur University of Medical Sciences and Health Services of Ahvaz, ground floor, university town, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.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
Majid Ravanbakhsh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Sciences faculty, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
4331385617
Phone
+98 61 3333 6754
Email
majidravanbakhsh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Ravanbakhsh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Sciences of Ahvaz University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
4331385617
Phone
+98 61 3333 6754
Email
majidravanbakhsh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vedad Abdolkhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 422, Pansion st, Newside alley, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
4331385617
Phone
+98 61 3443 5160
Email
abdolkhanivedad@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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All datas will be published
When the data will become available and for how long
from 2019
To whom data/document is available
Datas will be available for researchers
Under which criteria data/document could be used
Researchers who want to continue our research line
From where data/document is obtainable
They can send us emails to this mail address: majidravanbakhsh@yahoo.com
What processes are involved for a request to access data/document
first they must send us an email , explaining the reason they need the research data , after we checked them , we will send them the datas
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