Older People--Abuse ofOEPABTNCT06291792
Otago Exercise Program Applied By Telerehabilitation
A study testing telerehabilitation otago exercise program and face to face otago exercise program in people with Older People--Abuse of and Falling, run by Sinop University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Older People--Abuse of, Falling, Balance; Distorted
- What is being tested?
- telerehabilitation otago exercise program and face to face otago exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bahçeşehir University research application center
Istanbul
Sefa Haktan Hatık, PhD, haktanhtk@gmail.com
About this study
Official title: 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.
Read the detailed 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).
- Conditions
- Older People--Abuse of, Falling, Balance; Distorted
- Being tested
- telerehabilitation otago exercise program, face to face otago exercise program
- Keywords
- Fear of Falling, Balance, Older Persons, Telerehabilitation, Otago Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telerehabilitation otago exercise programOther
telerehabilitation otago exercise program
face to face otago exercise programOther
face to face otago exercise program
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Otago Exercise Group (TOEG) | Experimental | 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. Receives: Other: telerehabilitation otago exercise program |
| Face to face Otago Exercise Group (FOEG) | Experimental | 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. Receives: Other: face to face otago exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 10 minutes after intervention
Walking Speed
Walking Speed
Measured: within 10 minutes after intervention
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.
Measured: within 10 minutes after intervention
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.
Measured: within 10 minutes after intervention
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.
Measured: within 10 minutes after intervention
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.
Measured: within 10 minutes after intervention
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.
Measured: within 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Nov 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older People--Abuse ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SEFA HAKTAN HATIK, PhD, Study chair, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291792
- Sponsor's protocol ID
- FTR001
- Acronym
- OEPABT
- Status last verified
- Feb 2024
- First submitted
- 12 Jul 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Of Otago Exercise Program Applied By Telerehabilitation Method In Older Persons Individuals With A Fall Story
- ClinicalTrials.gov ID
- NCT06291792
- Acronym / sponsor ID
- OEPABT / FTR001
- Conditions
- Older People--Abuse of, Falling, Balance; Distorted
- Keywords
- Fear of Falling, Balance, Older Persons, Telerehabilitation, Otago Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Otago Exercise Group (TOEG) | Experimental | Other: telerehabilitation otago exercise programThe 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. |
| Face to face Otago Exercise Group (FOEG) | Experimental | Other: face to face otago exercise programOtago 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telerehabilitation otago exercise programtelerehabilitation otago exercise program | Other | Telerehabilitation Otago Exercise Group (TOEG) |
| face to face otago exercise programface to face otago exercise program | Other | Face to face Otago Exercise Group (FOEG) |
Primary outcome
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.
Walking Speed
Time frame: within 10 minutes after intervention
Walking Speed
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEFA HAKTAN HATIK, PhD study chair
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telerehabilitation otago exercise program and face to face otago exercise program in people with Older People--Abuse of and Falling, run by Sinop University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sefa Haktan HATIK, PhD (00905058761533, haktanhtk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Scale (time frame: within 10 minutes after intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.