The aim of this study was to investigate the The Effect of Equilibrium Exercise on the Effectiveness of Fear of Falling and Preventing Crashes in the Elderly 60-75 Years Old Woman in Lenjan City
Design
From the four health centers of Zarrin Shahr, the names of the two health centers are selected in lottery and used to extract the intervention samples using the electronic health record software, and from the remaining two remaining health centers are used to extract the control group.The number of samples in each group was 35.
Settings and conduct
The goal of the study is to investigate elderly women referring to health centers in Zarrinshahr, who are afraid of falling while taking care of the modern health services of the elderly. Then, the target population was randomly divided into two groups of test and control groups (lotteries of health centers names).
Participants/Inclusion and exclusion criteria
Women ages 60 to 75; Individual Satisfaction and Marital Satisfaction; Certified physician to participate in the exercise program; Self-report fear of falling during care
Inability to perform Equilibrium exercises under medical supervision; Unwillingness to participate in the study; Absence of more than 1 session during Equilibrium exercises; Participation in exercise sessions outside intervention program; Hospitalization due to acute illness or injury; People with diabetes; People with depression
Intervention groups
Intervention group: This group receives a batch of physical exercises called Equilibrium exercises for 8 weeks each week for 2 sessions and each session for 1 hour (totaling 16 hours) under the supervision of a sports expert.
Control group:This group, without knowledge of the intervention, intervenes in their normal care and life at the health center and does not exercise any activity
Main outcome variables
Effectiveness of Fear of Falling and Falling (fall down)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180216038754N1
Registration date:2018-04-05, 1397/01/16
Registration timing:registered_while_recruiting
Last update:2018-04-05, 1397/01/16
Update count:0
Registration date
2018-04-05, 1397/01/16
Registrant information
Name
Raheleh Soleymani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5262 6525
Email address
lenjan-health@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-05-04, 1397/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Equilibrium Exercises on the Effectiveness of Fear of Falling and Preventing Crashes in the Elderly
Public title
Falling in older adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women ages 60 to 75
Individual Satisfaction and Marital Satisfaction
Certified physician to participate in the exercise program
Self-report fear of falling during care
Exclusion criteria:
Inability to perform Equilibrium exercises under medical supervision
Unwillingness to participate in the study
Absence of more than 1 session during Equilibrium exercises
Participation in exercise sessions outside intervention program
Hospitalization due to acute illness or injury
People with diabetes
People with depression
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
From the four health centers of Zarrin Shahr, the names of the two health centers are selected in lottery and used to extract the intervention samples using the electronic health record software, and from the remaining two
remaining health centers are used to extract the control group.By referring to the health centers, the elderly healthcare electronic health records are reviewed first, then the elderly who questioned whether they are afraid of falling? Positive answers are listed, then they are Simple randomization selected from the list of odd's numbers and, if satisfied, are enrolled in the study.
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
International Bureau, Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.MUI.REC.1396.1.152
Health conditions studied
1
Description of health condition studied
Fear of falling
ICD-10 code
40.9
ICD-10 code description
Phobic anxiety disorder, unspecified
2
Description of health condition studied
Fall down
ICD-10 code
W00-W19
ICD-10 code description
Fall on same level from slipping, tripping and stumbling
Primary outcomes
1
Description
Effectiveness of fear of falling
Timepoint
Before the intervention, one month after the intervention, three months after the intervention
Method of measurement
Efficiency Scale Questionnaire for Elderly
Secondary outcomes
1
Description
Fall down
Timepoint
Before the intervention, one year after the intervention
Method of measurement
Care Questionnaire of fall and imbalances
Intervention groups
1
Description
Intervention group: This group receives a batch of physical exercises called Equilibrium exercises for 8 weeks each week for 2 sessions and each session for 1 hour (totaling 16 hours) under the supervision of a sports expert.
Category
Rehabilitation
2
Description
Control group:This group, without knowledge of the intervention, intervenes in their normal care and life at the health center and does not exercise any activity.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Lenjan city
Full name of responsible person
Rahele Soleimani
Street address
Family Health Unit, Health Center in Lenjan, Shariati St., Zarin Shahr
City
Zarin Shar
Province
Isfehan
Postal code
8471754749
Phone
+98 31 5223 2545
Email
lenjan-health@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Amir Mohammad Armanian
Street address
No. 4, Hezargarib st, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
lenjan-health@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Raheleh Soleymani
Position
Health Family Health Network Expert
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shariati St. Langian Health Center
City
Zarinshahr
Province
Isfehan
Postal code
8471754749
Phone
+98 31 5262 6525
Fax
Email
raheel_s59@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Raheleh Soleymani
Position
Health Family Health Network Expert
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shariati St. Langian Health Center
City
Zarinshahr
Province
Isfehan
Postal code
8471754749
Phone
+98 31 5262 6525
Fax
Email
raheel_s59@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Raheleh Soleymani
Position
Health Family Health Network Expert
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shariati St. Langian Health Center
City
Zarinshahr
Province
Isfehan
Postal code
8471754749
Phone
+98 31 5262 6525
Fax
Email
raheel_s59@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available