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Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Community Field Trial on Comparison of Otago Exercise Programme with General Health Programme on Falls Prevention among Elderly Community Dwellers
Protocol summary
Summary
This is a multicenter field trial (rural and urban health centers) in community which is conducted on random assignment and single blinded method to compare intervention and control groups. The purpose of the study is to assess the effectiveness of Otago Exercise Programme on prevention of falls among elderly community dwellers. Inclusion criteria were 60 years old and above, ability to perform Otago Exercise Programme and ability to walk 10 meters long, independently. Based on population of the community and prevalence of falls in community elder, 450 subjects were allocated in both control (225) and intervention (225) groups. The trial will last for 6 months with one year follow up. This study will be conducted on elderly community dwellers living in rural and urban areas. The intervention group will receive Otago exercise training and the control group will receive general health training for 6 months. Otago exercise a training programme designed and conducted in University of Otago, New Zealand. General health education is based on instructions of Ministry of Health, Treatment and Medical Education for elderly people. The results of the study will show the comparison of control and intervention groups’ scores in balance, falls incidence, self-efficacy, well-being and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2014012016285N1 Registration date: 2014-06-07, 1393/03/17 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2014-06-07, 1393/03/17 Registrant information
Name Ali Dadgari
Name of organization / entity
Shahroud University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 23 3239 5054 Email address
dadgari@shmu.ac.ir Recruitment status
Recruitment complete Funding source
Shahroud University of Medical Sciences
Expected recruitment start date 2012-01-21, 1390/11/01
Expected recruitment end date 2014-01-21, 1392/11/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Community Field Trial on Comparison of Otago Exercise Programme with General Health Programme on Falls Prevention among Elderly Community Dwellers Public title
Effectiveness of Otago Exercise Programme on Falls Prevention among Elderly Community Dwellers Purpose
Prevention
2 Inclusion/Exclusion criteria
Age 60 years old and above; able to do exercise; can walk 10 meters long independently
Age
From 60 years old to 99 years old Gender
Both Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 1200
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Single blinded Blinding description Placebo
Used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences Street address
Haft-e Tir Sq.
City
Shahroud Postal code Approval date
2010-09-23, 1389/07/01
Ethics committee reference number 9020
Health conditions studied
1
Description of health condition studied Otago Exercise Programme
ICD-10 code Z50.8
ICD-10 code description
Training in activities of daily living [ADL] NEC
Primary outcomes
1
Description Fall Timepoint
One year
Method of measurement Fall incidence during one year
2
Description Balance Timepoint One year
Method of measurement Berg Balance Score
Secondary outcomes
1
Description Self-efficacy Timepoint
One year
Method of measurement Falls Efficacy Scale
2
Description Well-being Timepoint
One year
Method of measurement
World Health Organization Five Well-being Index
3
Description Quality of Sleep Timepoint
Six months
Method of measurement Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Experimental group receives Otago exercise Programme for six months
Category Rehabilitation
2
Description
In control group general education for elderly people is conducted.
Category
3 Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center Rural and urban health centers Full name of responsible person
Physician in health center Street address
Shahroud University of Medical Sciences City
Shahroud
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Shahroud University of Medical Sciences Full name of responsible person
Ali Dadgari Street address
Haft-e Tir Sq.
City
Shahroud Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences Full name of responsible person
Ali Dadgari Position
Faculty member, Ph.D Candidate Other areas of specialty/work Street address
Haft-e Tir Sq.
City
Shahroud
Postal code Phone
+98 27 3339 5054 Fax
dadgari@shmu.ac.ir Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences Full name of responsible person
Ali Dadgari Position
MSc, Ph.D. Candidate
Other areas of specialty/work Street address
Shahroud University of Medical Sciences City
Shahroud Postal code Phone
+98 27 3339 5054 Fax
dadgari@shmu.ac.ir Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences Full name of responsible person
Ali Dadgari Position
MSc, PhD Candidate, Faculty member Other areas of specialty/work Street address
City
Shahroud Postal code Phone
+98 27 3339 5054 Fax
dadgari@shmu.ac.ir Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
4 Clinical Study Report
empty Analytic Code
empty Data Dictionary
empty
