Protocol summary

Summary
The aim of this study was to compare the effect of Pilates exercises and postural vital capacity, improving posture and balance in people with visual disorders. Blinding is not possible in this study blinding. The main inclusion criteria is visual impairment and postural disorders and cardiovascular disorders is the main exclusion criteria. The number of participants will be 90 people in three groups of 30 each. People are randomly divided into three groups. The first group received in addition to routine physical Pilates exercises, the second group received the routine physical exercises and postural last group received only benefit from physical therapy. The exercises are performed for two weeks that patients far more hyperkyphosis, vital capacity and the balance will be evaluated before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111530904N1
Registration date: 2016-12-09, 1395/09/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Mohammad Mehdi Beheshti Pour
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3773 3594
Email address
mbeheshti@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of effects of pilates and postural exercises on vital capacity postural improvement and balance on people with visual disorders
Public title
effects of exercise on Breathing, postural improvement and balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with visual impairments who are visually impaired according to Indicators of Well-Being Organization; People with visual impairments, women and males aged 35-55 years who are at least 10 years of getting past them to vision impairment; People who have completed consent form to participate in the study voluntarily wish to participate in this study; FHP people at them with an assessment of the plumb line approved Exclusion criteria: Systemic inflammatory diseases such as conjunctivitis; Patients with severe spinal canal stenosis, spondylolisthesis, fibromyalgia; Cancer patients and patients who recently underwent chemotherapy and radiotherapy; Pregnancy; Cardiovascular disease; Patients with neuromuscular problems and severe mental health problems; history of spinal surgery; Physiotherapy during the last 6 months on the spine; Respiratory problems; People with cerebellar problems, ear and central nervous system
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
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
Semnan University of Medical Sciences
Street address
Kilometer 5; Semnan Damghan road
City
Semnan
Postal code
Approval date
2016-11-12, 1395/08/22
Ethics committee reference number
ir.semums.rec.1395.141

Health conditions studied

1

Description of health condition studied
blindness binocular
ICD-10 code
H54.0
ICD-10 code description
Blindness, binocular

2

Description of health condition studied
Severe binocular visual impairment
ICD-10 code
H54.1
ICD-10 code description
Severe visual impairment, binocular

Primary outcomes

1

Description
static balance
Timepoint
Beginning of research and end of the eighth week
Method of measurement
Single-leg standing test

2

Description
Vital capacity
Timepoint
Beginning of research and end of the eighth week
Method of measurement
in milliliters with Spirometer

3

Description
Hyperkyphosis
Timepoint
Beginning of research and end of the eighth week
Method of measurement
in Degrees with The angle between Horizontal line passing through seventh cervical vertebrae and Filed the listen tab and seventh cervical vertebrae

4

Description
dynamic balance
Timepoint
Beginning of research and end of the eighth week
Method of measurement
Y balance test

Secondary outcomes

empty

Intervention groups

1

Description
Group Pilates exercises. 8-week period. 3 sessions per weeks exercise
Category
Rehabilitation

2

Description
Group Postural exercises. 8-week period. 3 sessions per weeks exercise
Category
Rehabilitation

3

Description
control Group. 8-week period. 3 sessions per weeks rutin phisiotherapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabatabai Research Center
Full name of responsible person
Mohammad Mehdi Beheshti Pour
Street address
Tabatabai Research Center; Mashahir Avenue; Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amoozade Khalili; Research assistant
Street address
kilometer 5; Semnan Damghan road
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Beheshti Pour
Position
Masters student
Other areas of specialty/work
Street address
House number36، Alley number 36، Honarestan street، Qom
City
Qom
Postal code
Phone
+98 25 3773 3594
Fax
Email
mmbeheshtipour@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amoozade Khalili
Position
phd
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1444 0225
Fax
Email
moh35ir@yahoo.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Beheshti Pour
Position
Masters student
Other areas of specialty/work
Street address
House number36، Alley number 36، Honarestan street، Qom
City
Qom
Postal code
Phone
+98 25 3773 3594
Fax
Email
mmbeheshtipour@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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