- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05213091
The Effect of Otago Exercises in the Elderly
September 13, 2022 updated by: Naile Bilgili, Gazi University
The Effect of Otago Exercises on Fear of Falling, Balance, Empowerment and Functional Mobility in Elderly: A Randomized Controlled Trial
Home-based and individually designed exercise program; It consists of warming up, strengthening, balance exercises and walking plan.
The number, intensity and duration of the movements are personalized according to preference and ability and are progressed gradually.
Elderly individuals are expected to do this set of exercises three times a week and walk for 30 minutes twice a week.
Since the Otago Exercise Programme includes combined exercises, the outputs of the effectiveness of the program will be different.
For this purpose, the effect of otago exercises on fear of falling, balance, strengthening and functional mobility will be determined in the elderly living in nursing homes.
Study Overview
Detailed Description
The first four weeks will be Otago Exercise Programme training and practice.
For the next weeks, there will be institution visits and telephone interviews.
Individuals will be given an Otago Exercise Programme training booklet, exercise chart and exercise diary to better manage this process.
The research will be conducted in small groups (average 6-8).
The control group is expected to continue their daily life.
No attempt will be made by the researcher during the research process.
Stratified randomization method according to age and gender was used in the study.
The website was used to assign individuals meeting the inclusion criteria in each stratum to a determined number of groups.
Masking will be done in terms of research data/output measurements (evaluator), statistician and reporting.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Çankaya/Ankara
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Ankara, Çankaya/Ankara, Turkey, 06490
- Gazi University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To be 65 years or older
- To be literate
- Having no problem in verbal communication
- Not having a disability based on sight, hearing and lack of limbs
- Obtaining at least 91 points or more according to the Barthel Activities of Daily Living Index (to be mildly dependent or completely independent)
- Mini Mental Test to be 24 points and above
- Having a doctor's report that it will not interfere with exercise
Exclusion Criteria:
- Having a medical contraindication for exercise
- Having acute or terminal illnesses and serious chronic illnesses that limit participation in exercise sessions
- Having a lower extremity fracture in the past year
- Having had an operation in the last month
- Being diagnosed with any neuropsychiatric disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Otago Exercise Group
Otago Exercise program wil be applied to the elderly.
|
The first four weeks will be Otago Exercise Programme training and practice.
For the next weeks, there will be institution visits and telephone interviews.
Individuals will be given an Otago Exercise Programme training booklet, exercise chart and exercise diary to better manage this process.
The research will be conducted in small groups (average 6-8).
Other Names:
|
No Intervention: Control Group
The elderly wil be expected to continue their daily life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Fall Efficacy Scale
Time Frame: Totally 12 weeks
|
The scale is used to determine the possible fear of falling in elderly individuals.
It is a visual analog scale consisting of fourteen questions.
Items are scored from zero to ten (never safe=0, totally safe=10).
A high score means high fall safety and proficiency.
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Totally 12 weeks
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Berg Balance Scale
Time Frame: Totally 12 weeks
|
The scale was developed to evaluate the balance levels of elderly individuals.
This scale consists of 14 items and each section is scored between 0 (bad) and 4 (best).
The scale score is in the range of 0-56 points, and an increase in the score indicates that the balance is good.
According to the total score obtained, "0-20 points: high risk of falling, balance disorder", "21-40 points: moderate risk of falling, presence of acceptable balance", "41-56 points: low risk of falling, presence of good balance" evaluated as ".
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Totally 12 weeks
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Elderly Empowerment Scale
Time Frame: Totally 12 weeks
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The scale is a short and practical tool for assessing the empowerment levels of the elderly.
The scale, which consists of a total of eight questions and a single factor, is in the five-point Likert type.
The lowest score obtained from the scale is 8, the highest score is 40.
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Totally 12 weeks
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30-Second Chair Stand Test
Time Frame: Totally 12 weeks
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It is a test that evaluates the sit-to-stand activity, lower extremity strength and dynamic balance of the individual.
The number of times an individual sits and stands in 30 seconds is recorded.
Three measurements will be made by giving rest intervals and the average will be recorded.
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Totally 12 weeks
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Handgrip Strength Measurement Test
Time Frame: Totally 12 weeks
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The purpose of the test is to test the maximum isometric contraction strength of the forearm muscles.
The average of the three measurements will be taken and recorded.
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Totally 12 weeks
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Timed Up & Go
Time Frame: Totally 12 weeks
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It is a test that evaluates mobility and fall risk in elderly individuals.
The individual is observed while getting up from the chair, walking 3 meters, turning, walking back and sitting again, and the elapsed time is recorded.
If the elderly person completes this test in more than 12 seconds, it is considered as "at risk of falling".
Three measurements will be made by giving rest intervals and the average will be taken.
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Totally 12 weeks
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6-Minute Walk Test
Time Frame: Totally 12 weeks
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It was developed to measure the functional capacity of individuals.
In the six-minute walking test, the patient walks along a 30-meter straight corridor as fast as he can, but without running.
How many meters he walked is measured and recorded.
Three measurements will be made by giving rest intervals and the average will be recorded.
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Totally 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2021
Primary Completion (Actual)
April 15, 2022
Study Completion (Actual)
August 15, 2022
Study Registration Dates
First Submitted
December 24, 2021
First Submitted That Met QC Criteria
January 15, 2022
First Posted (Actual)
January 28, 2022
Study Record Updates
Last Update Posted (Actual)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2021-465
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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