Protocol summary

Study aim
Comparison of the Effectiveness of Two NASM and Sahreman Approaches on Modification of Hyperkyphosis, Front Rupture and Increased Postural Fluctuation in Male Students of Razi University
Design
Randomized control trial- two parallel groups-three blinded
Settings and conduct
The study will be conducted at the Razi University Sports Rehabilitation Laboratory In this randomized, three-blind randomized trial, 30 male students who participated in physical examinations of the University Health Center who had kyphosis with headache were randomly assigned to two NASM training groups (Random number generator). N = 15 and the Sahrmann approach training group (n = 15). In the pre-test and post-test phase, out-come measures will be assessed.
Participants/Inclusion and exclusion criteria
18-22 years, kyphosis > 45 ° and forward head > 49 °, no spinal fracture, no bone and joint disease. Exclusion criteria included another regular training participating, physical disabilities, cardiovascular disease, diabetes, balance problems, and neuromuscular disorders.
Intervention groups
Group 1: Eight weeks, three sessions per week, and one hour of NASM approach training, will be executed: First, we perform the inhibitory exercises and then the stretching exercises on the shortened and tightness muscles. Then, during the activation phase: we strengthen the weak and elongated muscles, and finally perform the integrated exercises. Group 2 Sahrmann: Strength training will be performed in the form of 70% to 80% of subjects' cognitive ability and based on the Borg Exercise Intensity scale of 10-12.
Main outcome variables
the kyphosis angle will be measured by a spinal mouse, the head angle will be measured by Autocad software, and the evaluation of foot pressure and postural sways by the PT-Scann device. and respiratory function will be measured by spirometer.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190426043377N2
Registration date: 2020-03-29, 1399/01/10
Registration timing: retrospective

Last update: 2020-03-29, 1399/01/10
Update count: 0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Farzaneh Gandomi
Name of organization / entity
دانشگاه رازی
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 3272
Email address
gandomi777@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2020-01-21, 1398/11/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-05-21, 1399/03/01
Scientific title
The effect of Corrective Approach on Hyper Kyphosis, Forward Head Posture Correction, Increased Postural Sways and Respiratory Function of Students
Public title
The effect of Corrective Approach on Hyper Kyphosis and Forward Head Posture of Students
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
18-22 old range kyphosis > 45 forward head >49 without any spine fracture without any shoulder and neck joint disease no participated in any treatment training 6 months ago
Exclusion criteria:
participated in other training physical disability heart disease neuromascular and balance disease
Age
From 18 years old to 22 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate participants to the research groups, a computerized list of random numbers was assigned to randomly assign the subjects to individual blocks (2, 4, 6, 8) using SPSS software. Participants are then assigned by a research team member who is not involved with the 1: 1 allocation ratio in the training groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The allocation sequence is concealed by opaque envelopes numbered sequentially, and letter envelopes are opened only after all initial and baseline assessments of the participants have been completed. The random allocation sequence is performed by a study contributor who is not involved in the evaluations and remains hidden from the evaluators and other research partners. Due to the nature of the study evaluator is blinded to the division of participants into groups, participants and the statistical expert and evaluator are also blinded to the division of participants into groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
RAZI University
Street address
Baghe Abrisham
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.RAZI.REC.1298.006

Health conditions studied

1

Description of health condition studied
increased kyphosis and forward head posture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
kyphosis-forward head posture
Timepoint
pre interventions and one day after finished interventions
Method of measurement
laboratory

Secondary outcomes

1

Description
foot pressure, postural sways, range of motion, muscle strength, respiratory function
Timepoint
pre interventions and one day after finished interventions
Method of measurement
laboratory

Intervention groups

1

Description
Intervention group: NASM Intervention caried out for 8-week three sessions and for 60 minuets. first self resales training then stretching exercises and subsequently activation and integrated exercise will be executed. foam roller, tubing bands with various resistance, gem ball, butterfly tubing, various weight dumbbell, massage balls,... are used.
Category
Rehabilitation

2

Description
Intervention group: sahrmann training: Intervention caried out for 8-week three sessions and for 60 minuets per session.for forward head posture, we focused on deep neck flexors strengthening. for kyphosis , we focused on trunk extensors strengthening. strengthening and hypertrophy was done by tranand, various weight dumbbell and body weight.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
RAZI University Health Center
Full name of responsible person
Saber Baigi
Street address
bagh-e-Abrisham
City
kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3276
Email
saber.beygie@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi university
Full name of responsible person
Street address
baghe abrisham
City
kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3272
Email
Grant name
Farzad Vaisi
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi university
Proportion provided by this source
10
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
RAZI University
Full name of responsible person
farzaneh gandomi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
corrective exercises
Street address
baghe abrisham
City
kermanshah
Province
Kermanshah
Postal code
6714414864
Phone
+98 83 3428 3272
Email
gandomi777@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
RAZI University
Full name of responsible person
farzaneh gandomi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
corrective exercises
Street address
baghe Abrishan\m
City
kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3728 3272
Email
gandomi777@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
RAZI University
Full name of responsible person
farzaneh Gandomi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
corrective exercises
Street address
baghe abrisham
City
kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3272
Email
gandomi777@gmail.com

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
there aren't furthers information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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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