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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06291792
Other study ID # FTR001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date March 1, 2024

Study information

Verified date February 2024
Source Sinop University
Contact Sefa Haktan HATIK, PhD
Phone 00905058761533
Email haktanhtk@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Those using a randomized controlled clinical trial model that includes assessment methods over four different time periods. Detailed information about the procedure to be applied was given to each participant who would participate in the study. After the information, mini mental state test was applied to the participants who signed the consent form. Gender, age, weight, height, number of falls in the last 1 year, body mass indexes were calculated and recorded, including demographic information of the participants who met the inclusion criteria. Participants were randomly divided into 3 groups. The groups are; telerehabilitation otago exercise program (TOEG) (n=15, 8 males, 7 females), face-to-face otago exercise program (FOEG) (n=15, 8 males, 7 females), Control Group (CG) (n=15) , 8 men, 7 women).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
telerehabilitation otago exercise program
telerehabilitation otago exercise program
face to face otago exercise program
face to face otago exercise program

Locations

Country Name City State
Turkey Bahçesehir University research application center Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sinop University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical Pain Scale 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
Primary Walking Speed Walking Speed within 10 minutes after intervention
Primary lower extremity muscle strength 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
Primary Fall effectiveness scale 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
Primary Beck anxiety scale 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
Primary Tinetti balance and walking test 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
Primary World Health Organization Quality of Life Scale: 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
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