Healthy AgingNCT05213091
The Effect of Otago Exercises in the Elderly
A study testing Otago Exercise Programme in people with Healthy Aging, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Otago Exercise Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2021to 15 Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- Otago Exercise Programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgrammeOther
Also called Otago exercise programme training and implementation, phone call, institution visit
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).
| Study group | Role | What they receive |
|---|---|---|
| Otago Exercise Group | Experimental | Otago Exercise program wil be applied to the elderly. Receives: Other: Otago Exercise Programme |
| Control Group | No intervention | The elderly wil be expected to continue their daily life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fall Efficacy Scale
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.
Measured: Totally 12 weeks
Berg Balance Scale
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 ".
Measured: Totally 12 weeks
Elderly Empowerment Scale
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.
Measured: Totally 12 weeks
30-Second Chair Stand Test
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.
Measured: Totally 12 weeks
Handgrip Strength Measurement Test
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.
Measured: Totally 12 weeks
Timed Up & Go
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.
Measured: Totally 12 weeks
6-Minute Walk Test
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.
Measured: Totally 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start20 Sep 2021
- Primary completion15 Apr 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naile Bilgili, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213091
- Sponsor's protocol ID
- 2021-465
- Status last verified
- Sep 2022
- First submitted
- 24 Dec 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Otago Exercises on Fear of Falling, Balance, Empowerment and Functional Mobility in Elderly: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05213091
- Acronym / sponsor ID
- 2021-465
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 28 Jan 2022 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Group | Experimental | Other: Otago Exercise ProgrammeOtago Exercise program wil be applied to the elderly. |
| Control Group | No intervention | –The elderly wil be expected to continue their daily life. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Otago Exercise ProgrammeAlso: Otago exercise programme training and implementation, phone call, institution visitThe 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 | Otago Exercise Group |
Primary outcome
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.
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 ".
Elderly Empowerment Scale
Time frame: Totally 12 weeks
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.
30-Second Chair Stand Test
Time frame: Totally 12 weeks
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.
Handgrip Strength Measurement Test
Time frame: Totally 12 weeks
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.
Timed Up & Go
Time frame: Totally 12 weeks
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.
6-Minute Walk Test
Time frame: Totally 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Programme in people with Healthy Aging, run by Gazi 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 14 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fall Efficacy Scale (time frame: Totally 12 weeks). 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 14 Sep 2022.