Evaluation of the effects of 4 weeks exercise with flexible-bar on thoracic kyphosis angle and maximum voluntary contraction of thoracic muscles in postural hyperkyphosis people (18 -35 years old) with and without forward head posture
Evaluation of the effect of flexible-bar exercise on kyphosis angle and maximum voluntary contraction of thoracic muscles in postural hyperkyphosis people with and without forward head posture after 4 weeks treatment session
Design
Randomized trial with control and intervention groups, single blinded on 24 postural hyperkyphosis subjects
Settings and conduct
Twenty subjects with hyperkyphosis and with and without forward head posture will divide random in two groups according to the inclusion and exclusion criteria. The subjects in intervention group will exercise 4 weeks and The control group receives no exercise . The kyphosis angle, the craniovertebral angle, quality of life, thoracic pain and the maximum voluntary contraction in :back extensor,neck extensor ,lower and upper trapezius and levator scapulae muscles will measured befor and after 4 weeks as Pre and post test.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Men and women between18 to 35 years old
Having pain less than 3 in thoracic level with numeric pain rating scale(NRS)
Having hyperkyphosis angle more than 46 and less than 60 degree
Having craniovertebral angle less than 50 degree
Exclusion criteria:
Having body mass index more than 25
Having kyphosis with bone ,metabolic reason for example tuberculosis and large breast in women
Losing any of inclusion criteria
Having history of spinal surgery,infection,fracture,rheumatism
pregnancy
History of professional exercise in upper trunk and shoulder
Scoliosis
Having respiration and heart problem
Intervention groups
Applying flexible-bar exercise in intervention group and no intervention in control group
Main outcome variables
Kyphosis angle,craniovertebral angle, maximum voluntary contraction,quality of life, thoracic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090203001637N11
Registration date:2021-03-01, 1399/12/11
Registration timing:prospective
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Sedighe Kahrizi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4511
Email address
kahrizis@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of 4 weeks exercise with flexible-bar on thoracic kyphosis angle and maximum voluntary contraction of thoracic muscles in postural hyperkyphosis people (18 -35 years old) with and without forward head posture
Public title
Evaluation of the effects of exercise with flexible-bar on thoracic kyphosis angle in young people (18 -35 years old)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between18 to 35 years old
Having at least high school diploma education
Having pain less than 3 in thoracic level with Numeric Pain Rating Scale(NRS)
Having hyperkyphosis angle more than 46 and less than 60 degree
Having cranio-vertebral angle less than 50 degree
Exclusion criteria:
Having body mass index more than 25
Having history of spinal surgery,infection,fracture,rheumatism
Pregnancy
History of professional exercise in upper trunk and shoulder
Scoliosis
Having respiration and heart problem
having Kyphosis with other reasons for example structure deformity, metabolic tuberculosis, and having large breast in women
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is performed by randomize table numbers, with due attention to sample size that is 24 people, are given one two digit code to each subject and researcher start by chance from one point of table to selection of subjects and do this work with closed eyes and put finger or pen nib on the table and select the numbers in the direction of row or column and do this work til the end of sample size and thus subjects stay on two intervention and control group by chance
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant subjects are blinded to the kind of the group that they stay on it (intervention and control). Thus subjects of two groups have no meet and assessments are done separately in even and odd days
Placebo
Not used
Assignment
Parallel
Other design features
Intervention group subjects will exercise with flexible bar and control group subjects will not have any exercise
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ُTarbiat Modares University
Street address
Tarbiat ModaresUuniversity, Nasr bridge, Jalal e al e ahmad street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2020-12-15, 1399/09/25
Ethics committee reference number
IR.MODARES.REC.1399.140
Health conditions studied
1
Description of health condition studied
Subjects with Postural hyper kyphosis
ICD-10 code
M40.0
ICD-10 code description
Postural kyphosis
Primary outcomes
1
Description
Kyphosis angle
Timepoint
Before first exercise session and 24 hours post of last exercise session
Method of measurement
Flexicurve ruler
2
Description
Craniovertebral(CVA) angle
Timepoint
Before first exercise session and 24 hours post of last exercise session
Method of measurement
Goniameter
3
Description
Maximum Voluntary Contraction(MVC) of back extensor, lower trapezius, upper trapezius, neck extensor, levator scapulae muscles
Timepoint
Before first exercise session and 24 hours post of last exercise session
Method of measurement
Recording with Electromyography system
Secondary outcomes
1
Description
score of the Quality of life questionnaire
Timepoint
Before first exercise session and 24 hours post of last exercise session
Method of measurement
Persian version of the Sf36 Questionnaire
2
Description
Pain of the back region
Timepoint
Before first exercise session and 24 hours post of last exercise session
Method of measurement
Numeric Pain Rating Scale
Intervention groups
1
Description
Intervention group: exercise with flexible-bar 6 days in 4 weeks (24 session) and 3 sets in each session. number (adding one set) and time (adding 5 seconds) of doing sets increase progressively each weak. to prevent from fatigue, allocated 30 seconds rest between each set
Category
Rehabilitation
2
Description
Control group: No intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Sedighe Kahrizi
Street address
Tarbiat Modares University, Jalal e ale ahmad Avenue, Kouye Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8828 4511
Fax
+98 21 8288 4555
Email
Kahrizis@modares.ac.ir
Web page address
https://www.modares.ac.ir/~kahrizis
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tarbiat Modares University
Full name of responsible person
Dr.Yaghoub Fathollahi
Street address
Tarbiat Modares University, Jalal e ale ahmad Avenue, Kouye Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8828 9002
Email
Res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Zohreh Vaseghi Fard
Position
Student of M.sc in physical therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Jalale al e ahmad Ave, Kouye Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+9888284511
Email
v.zohreh@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedighe Kahrizi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8828 4511
Email
Kahrizis@modares.ac.ir
Web page address
https://www.modares.ac.ir/~kahrizis
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedighe Kahrizi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8828 4511
Email
kahrizis@modares.ac.ir
Web page address
https://www.modares.ac.ir/~kahrizis
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
File of intervention program protocol and statistical analysis plan through publication of thesis and writingan article
When the data will become available and for how long
Starting 6 months after publication of results
To whom data/document is available
The research team of this study and other clinical academic researchers who are studying in favor of these patients
Under which criteria data/document could be used
Researchers who intend to write a meta-analysis or systematic review articles are allowed to access document
From where data/document is obtainable
Dr.sedighe kahrizi , Zohreh vaseghi fard
What processes are involved for a request to access data/document
The request will be responded after getting the approval of university or the academic institution