Protocol summary

Summary
The aim of present study is to investigate the simple balancing exercises' effects on increasing the balance ability and decreasing falls among the elderly women. The study was a randomized controlled clinical trial (RCT). For this purpose, 60 elderly people were randomly divided into two 30-member intervention and control groups in Razi psychiatric hospital. Inclusion criteria: all patients with chronic schizophrenia, age range between 60-84 years and consuming mild psychotic drugs (none of the participants of invasive procedures such as shock therapy, fixed and do not use). For all patients, demographic data including age, marital status, length of stay, height, weight, BMI, education, the family background of the disease, history of falls, smoking, cause of admission, etc. were extracted. Before beginning the study, "Timed up and go" test was completed for each patient. The patients in intervention group were trained about simple balance exercises by an occupational therapist via 30-minutes sessions, three times a week for 12 weeks. The control group did not receive any special treatments throughout the study. At the end of the study, all patients were assessed again by Time Up and go test.Primary outcomes in this study were the velocity of sitting down and standing up.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041827448N1
Registration date: 2016-07-15, 1395/04/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-15, 1395/04/25
Registrant information
Name
Masome Rezaie Evrigh
Name of organization / entity
Qazvin Univercity Of Sciences Medical
Country
Iran (Islamic Republic of)
Phone
+98 28333360015
Email address
khz@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2016-01-08, 1394/10/18
Expected recruitment end date
2016-03-17, 1394/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of simple balance exercise on falling prevention in elderly women
Public title
The effect of simple balance exercise on falling prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women aged 60-84 years diagnosed with chronic schizophrenia hospitalized in the Razi Psychiatric Hospital; Permanent treatment with antipsychotic medication; Ability to move without help and absence of physical illness; written consent. Exclusion criteria: being absent for more than three sessions; physical illness; death.
Age
From 60 years old to 84 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
accident numerics chart

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
The next Justice، Bahonar street، Qazvin
City
Qazvin
Postal code
Approval date
2016-11-13, 1395/08/23
Ethics committee reference number
IR.QUMS.REC.1394.197

Health conditions studied

1

Description of health condition studied
fall
ICD-10 code
R29.6
ICD-10 code description
Tendency to fall, not elsewhere classified

Primary outcomes

1

Description
Primary outcome:Sitting down and standing up speed
Timepoint
Before and one week after intervention
Method of measurement
up to go criterion

Secondary outcomes

empty

Intervention groups

1

Description
Intervention groups: Education of simple balance training for patients will be held up. Educational sessions will be ran as 30-minute sessions, three times a week up to 12 weeks.
Category
Prevention

2

Description
Control group: we do not do for them anything
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Psychiatric Center, Tehran University of Social Welfare
Full name of responsible person
Dr.Azam Soleymani
Street address
Shahid Rastegary street, Amin abad ,Rey
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin Univercity of Medical Sciences
Full name of responsible person
Dr.Fateme Mohammadi
Street address
Next Court of Law، Bahonar street ،Qazvin
City
Qazvin
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Qazvin Univercity 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
Qazvin Univercity of Medical Sciences
Full name of responsible person
Masome Rezaie
Position
MS in Geriactric Nursing
Other areas of specialty/work
Street address
Next justic ،Bahonar street ،Qazvin
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
masomerezai265@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin Univercity of Medical Sciences
Full name of responsible person
Dr.Fateme Mohammadi
Position
Ph.D in Geriactric nursing
Other areas of specialty/work
Street address
Next Court of Law, Bahonar street, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
mohammadi1508@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Razi Psychiatric hospital
Full name of responsible person
Masome Rrezaei
Position
MS in Nursing
Other areas of specialty/work
Street address
Rastegari Street, Amin abad, Rey
City
Tehran
Postal code
Phone
+98 21 3340 1224
Fax
Email
masomerezai265@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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