- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06291792
Otago Exercise Program Applied By Telerehabilitation (OEPABT)
Efficiency Of Otago Exercise Program Applied By Telerehabilitation Method In Older Persons Individuals With A Fall Story
The aim of this study is to examine the effects of Otago Exercise Program (OEP) on pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life and balance with the telerehabilitation method in individuals with a history of falling, which is frequently seen in elderly individuals due to aging.
45 people between the ages of 65 and 78 participated in the study. They were randomly divided into 3 groups as control, telerehabilitation otago exercise program (TOEG) and face-to-face otago exercise program (FOEG). 45 minutes of OEP was applied 3 times a week for 8 weeks. Pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life, and balance were evaluated before the Otago Exercise Program, at the 4th week, at the 8th week, and 4 weeks after the end of the exercise program. Significance was evaluated at the p<0.05 level in the study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sefa Haktan HATIK, PhD
- Phone Number: 00905058761533
- Email: haktanhtk@gmail.com
Study Locations
-
-
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Istanbul, Turkey
- Recruiting
- Bahçeşehir University research application center
-
Contact:
- Sefa Haktan Hatık, PhD
- Email: haktanhtk@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of the ability to walk without assistance
- Living independently at home
- Having a history of at least one fall in the last 12 months
Exclusion Criteria:
- Having a score below 24 on the Mini Mental State Test
- Using a walking aid
- Having a history of uncontrolled epileptic seizures
- Having a history of surgery within the last six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telerehabilitation Otago Exercise Group (TOEG)
The use of Otago Exercise Program in the home environment using the telerehabilitation method. Telerehabilitation was performed with video and audio interviews 3 times a week for 45 minutes. The study will take 12 weeks. An 8-week treatment protocol will be applied. 4 weeks after the treatment protocol, the last measurement will be made and the study will be terminated. |
telerehabilitation otago exercise program
|
Experimental: Face to face Otago Exercise Group (FOEG)
Otago Exercise Program was applied in a face-to-face clinical setting. Interviews were held 3 times a week for 45 minutes. The study will take 12 weeks. An 8-week treatment protocol will be applied. 4 weeks after the treatment protocol, the last measurement will be made and the study will be terminated. |
face to face otago exercise program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Pain Scale
Time Frame: within 10 minutes after intervention
|
Numerical pain scale is used to classify pain from 1 to 10. 1 represents the lowest and 10 represents the highest pain value.
|
within 10 minutes after intervention
|
Walking Speed
Time Frame: within 10 minutes after intervention
|
Walking Speed
|
within 10 minutes after intervention
|
lower extremity muscle strength
Time Frame: within 10 minutes after intervention
|
lower extremity muscle strength measurement; It is used to determine the strength rate of lower extremity muscles.
Muscles are classified from 0 to 5 according to the resistance applied against them and the counter force they show.
While 0 indicates the lowest muscle strength, 5 indicates the highest muscle strength.
|
within 10 minutes after intervention
|
Fall effectiveness scale
Time Frame: within 10 minutes after intervention
|
There are 10 questions asked to the participant that are relevant to daily life at home.
Each of the questions is answered numerically with a score between 1 and 10.
The sum of the answers gives the total result of the test.
If the result is higher than 70 points, the individual's fear of falling is high.
As the fear of falling increases, the score of the test increases.
|
within 10 minutes after intervention
|
Beck anxiety scale
Time Frame: within 10 minutes after intervention
|
This scale asks about situations related to the person's body that are indicative of anxiety, such as sweating, shaking, fear, and discomfort in various areas.
There are a total of 21 questions and 4 verbal answers that can be given to each question.
Each verbal response has 4 different numerical scores between 0 and 3.
At the end of the test, the numerical scores of the answers are added up.
The total score gives the result of the test.
If it is less than 21 points, the anxiety is low, between 22 and 35 points, the anxiety is moderate, and if it is 36 and above, it is said that there is severe anxiety.
|
within 10 minutes after intervention
|
Tinetti balance and walking test
Time Frame: within 10 minutes after intervention
|
It examines balance and walking status in 2 categories. There are 9 balance questions, followed by 7 questions about walking. There are 16 questions in total. A simple standard chair, a timer and a distance of about 15 meters is sufficient. Each question has 3 answers and each answer has numerical values of 0, 1, 2. The total score is calculated by adding the total score of the balance questions and the total score of the walking questions. The maximum score that balance questions can receive is 26, and the maximum score that walking questions can receive is 9. Total test score can be maximum 35. If the total test score is less than 18, it indicates a high risk of falling, if it is between 19-24, it indicates a slight risk, and if it is 24 and above, it indicates a low risk of falling. |
within 10 minutes after intervention
|
World Health Organization Quality of Life Scale:
Time Frame: within 10 minutes after intervention
|
This scale, developed for scientific research and clinical studies on the elderly, consists of 24 questions.
It aims to measure the quality of life of the elderly individual.
Each question has 5 verbal answers and each verbal answer has a numerical value between 1 and 5.
At the end of the test, the numerical values of all answers are summed.
The total score gives the result of the test.
As the score of the test increases, the quality of life of the elderly participant also increases.
|
within 10 minutes after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: SEFA HAKTAN HATIK, PhD, Sinop University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FTR001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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