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The effect of otago exercise program on balance and fear of falling in the elderly

Protocol summary

Study aim
To determine the effectiveness of the Otago Exercise Program in improving the balance and fear of falling in the elderly
Design
Clinical trials with control group, community-based and pragmatic, With parallel groups and randomized
Settings and conduct
This research will be implemented in the Imam Reza (AS) Clinic affiliated to Shiraz University of Medical Sciences. The 88 volunteer will be randomized in two groups of 44 people.The Otago training program will be conducted by the researcher to the experimental group for a period of four weeks, two sessions per week. The control group will not receive any training. After that, the participants will run Otago at their homes for 8 weeks, and they will be in touch with researcher. At the end of the third month, again, a meeting will take place to conduct the post-test.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1-aged 60 years and older 2. Earn score 45 or lower in Berg Balance Scale 3. Not affiliated with auxiliary equipment 4. Obtain a score of 22 up in Mini Mental Status exam 5. Obtain a score of 32 in Dizziness Handicap Inventory Test Exclusion Criteria: 1-Unwillingness to cooperate in research 2. Having defective vision or hearing impairment 3. Having a disabling neurological and muscular disorder that can lead to inability to do daily activities. 4 - Neurological disorders or defective disabling of the nervous system 5. Suffering from debilitating vascular diseases 6. Take medications that may affect balance.
Intervention groups
Intervention group: recipient of the Otago exercise program in eight sessions, thirty minutes each, in a month, and performed at home for two months with the supervision of a physiatrist. Control group: They are on the waiting list and do not receive comparative sport education intervention
Main outcome variables
Balance, Fear of falling

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131117015426N7
Registration date: 2019-06-17, 1398/03/27
Registration timing: retrospective

Last update: 2019-06-17, 1398/03/27
Update count: 0
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
Maryam Hazrati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 3949
Email address
hazratim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-05, 1397/07/13
Expected recruitment end date
2018-10-20, 1397/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of otago exercise program on balance and fear of falling in the elderly
Public title
Otago Exercise Program & Balance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
60 years and older Earning a score of 45 or lower in a Berg's equilibrium test (represents an average and downward balance of the elderly.) Not affiliated with auxiliary equipment such as walker and cane To earn a score of 22 up in the cognitive examination exam (indicates a lack of cognitive impairment in the elderly). Earn score 32 in the disability-induced disorder questionnaire (indicating no dizziness imbalance).
Exclusion criteria:
Unwillingness to cooperate in research Having defective vision or disabling hearing Having a disabling neurological and muscular disorder that can lead to inability to do daily activities. Neurological disorders or defective disabling of the nervous system Having debilitating vascular diseases Use of medications that may affect the balance of the person, including benzodiazepines, barbiturates, antidepressants, antihistamines, antipsychotics and other sedative and hypnotic tablets
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
In the present clinical trial, random allocation of the participants is done via permuted block randomization. Accordingly, A and B represent the individuals receiving and not receiving the intervention, respectively. This method is run on 22 blocks in four permutations by considering all possible quadruple permutations (ABBA, ABAB, AABB, BBAA, BAAB, and BABA) and assigning a code between 0 and 9 (based on the table of random numbers) to each permutation (AABB, code 0; ABAB, code 1; ABBA, code 2; BAAB, code 3; BBAA, code 4; and BABA, codes 5-9). Then, based on the table of random numbers, a starting point is randomly selected, 12 digits are randomly chosen (in a row or column), and the permutation assigned to each digit is written down. It should be noted that the permutations are placed next to each other from left to right. Afterwards, allocation of the 88 participants to groups A and B is determined.
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 Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2018-09-28, 1397/07/06
Ethics committee reference number
IR.SUMS.REC.1397.563

Health conditions studied

1

Description of health condition studied
Imbalance
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Fear of falling
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
balance score in Berg's balance scale
Timepoint
Before and after the intervention
Method of measurement
Berg's Balance Scale

2

Description
Fear of falling score in Falling Efficiency Scale-International
Timepoint
Before and after the intervention
Method of measurement
Falling Efficiency Scale-International

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A group of Otago exercise program is trained by weekly program (twice a week) under the supervision of the trainer and for 30 minutes per session for Intervention group. The intervention program will include 8 training sessions in a month and then continues on exercise at home and will be followed up by phone for 2 months. This intervention is carried out under the supervision of a physiatrist.
Category
Rehabilitation

2

Description
Control group: Participants in this group are on the waiting list and do not receive comparative sport education intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Elderly Clinic of Imam Reza Clinic
Full name of responsible person
Maryam Hazrati
Street address
Specialized Clinic and Imam Reza Specialist, Side of Blood Transfusion Organization, Namazai Square
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs, Zand Ave.
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Hazrati
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh School of Nursing and Midwifery , Namazi Hospital ,Namazi Square , Shiraz
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4287
Email
hazratim@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Hazrati
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh School of Nursing and Midwifery,Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4287
Email
hazratim@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Hazrati
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4287
Email
hazratim@sums.ac.ir

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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
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