GeriatricsOtago ExerciseNCT06267833
The Effect of Trunk and Upper Extremity Exercises Added to the Otago Exercise Program
A study testing exercise in people with Geriatrics and Balance, run by Muğla Sıtkı Koçman University.
Trial summary
This study is designed to investigate the effect of adding trunk and upper extremity exercises in traditional and mobile game formats to the Otago exercise program on balance performance, fall risk, and fear in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatrics, Balance, Exercise
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Jun 2026
- 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 aged 65 years and older.
- To have the ability to speak, read, comprehend, and write in Turkish.
- To have a body mass index <35 kg/m2 (not being severely or morbidly obese).
- To have experienced one or more falls within the past 1 year.
- To possess cognitive abilities enabling the understanding and implementation of the educational sessions to be conducted in the study (having scored ≥ 24 points on the Mini-Mental State Examination).
- To be able to perform daily activities independently (scoring 5-6 points on the Katz Activities of Daily Living Scale).
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- To demonstrate a reach performance of ≥ 16 centimeters in the Functional Reach Test.
- To be able to walk independently (regardless of the use of walking aids).
- To have internet connectivity at home.
- To permit the implementation of exercise protocols under the supervision of the researcher in the home environment.
- To allow for periodic home visits by the researcher for the implementation of exercise protocols.
- To agree to have a physically suitable area in the home for exercise protocols or to make necessary arrangements to render the home environment suitable for exercise.
Who cannot join
- To have absolute contraindications for strength and aerobic exercises.
- To have chronic pain in the lower body and extremities.
- To have a disorder related to the vestibular system.
- To engage in regular exercise that may affect performance outcomes.
- To decline participation in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Adding Trunk and Upper Extremity Exercises to the Otago Exercise Program on Balance Performance, Fall Risk, and Fear of Falling in Older Adults
This study is designed to investigate the effect of adding trunk and upper extremity exercises in traditional and mobile game formats to the Otago exercise program on balance performance, fall risk, and fear in older adults. A randomized controlled, cross-sectional, single-blind (evaluator) study will be conducted with 36 older adults aged 65 and older enrolled at Muğla Sıtkı Koçman University (MSKÜ) Elderly Studies Application and Research Center. Participants will be divided into three randomized groups: control group (12 individuals receiving the Otago exercise program), study group 1 (12 individuals receiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program), and study group 2 (12 individuals receiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program). Participant demographics informations will be recorded in Form 1. Participants' cognitive functions , levels of independence in activities of daily living, fall risk , and fear of falling will be evaluated. Balance performance will be assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest), portable computerized kinetic balance measurement (SportKAT 650-TS), "5 Times Sit-to-Stand" and "Four-Stage Balance Test" from the Otago Exercise Program. Participants' body sway will be assessed simultaneously with the second part of the Mini-BESTest using a mobile application. All assessments will be conducted by a researcher blinded to the exercises, both before and after the exercises, in a one-on-one face-to-face setting. In the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method. Telerehabilitation sessions will be conducted via an Android-based tablet if the study is supported by Tübitak 1002 A Rapid Support Module. Individual smartphones of participants will be used if the study is not supported. All questionnaires, scales, and tests used in the initial assessments will be repeated at the end of the 8-week exercise protocol for all participants.
- Conditions
- Geriatrics, Balance, Exercise, Fall Prevention
- Being tested
- exercise
- Keywords
- Geriatrics, Balance, Fall prevention, Mobil game, telerehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
In the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Receiving the Otago exercise program Receives: Behavioral: exercise |
| Study group 1 | Experimental | Receiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program Receives: Behavioral: exercise |
| Study group 2 | Experimental | Receiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini BESTest
Mini Balance Evaluation Systems Test
Measured: 15 minutes
Secondary outcomes (2)
Functional Reach Test
Assessment risk of falling
Measured: 3 minutes
International Falls Efficacy Scale
Assessment fear of falling
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Murat, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267833
- Sponsor's protocol ID
- MSKUSBFFTR01
- Acronym
- Otago Exercise
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Trunk and Upper Extremity Exercises to the Otago Exercise Program on Balance Performance, Fall Risk, and Fear of Falling in Older Adults
- ClinicalTrials.gov ID
- NCT06267833
- Acronym / sponsor ID
- Otago Exercise / MSKUSBFFTR01
- Conditions
- Geriatrics, Balance, Exercise, Fall Prevention
- Keywords
- Geriatrics, Balance, Fall prevention, Mobil game, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 20 Feb 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.
This study is designed to investigate the effect of adding trunk and upper extremity exercises in traditional and mobile game formats to the Otago exercise program on balance performance, fall risk, and fear in older adults. A randomized controlled, cross-sectional, single-blind (evaluator) study will be conducted with 36 older adults aged 65 and older enrolled at Muğla Sıtkı Koçman University (MSKÜ) Elderly Studies Application and Research Center. Participants will be divided into three randomized groups: control group (12 individuals receiving the Otago exercise program), study group 1 (12 individuals receiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program), and study group 2 (12 individuals receiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program). Participant demographics informations will be recorded in Form 1. Participants' cognitive functions , levels of independence in activities of daily living, fall risk , and fear of falling will be evaluated. Balance performance will be assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest), portable computerized kinetic balance measurement (SportKAT 650-TS), "5 Times Sit-to-Stand" and "Four-Stage Balance Test" from the Otago Exercise Program. Participants' body sway will be assessed simultaneously with the second part of the Mini-BESTest using a mobile application. All assessments will be conducted by a researcher blinded to the exercises, both before and after the exercises, in a one-on-one face-to-face setting. In the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method. Telerehabilitation sessions will be conducted via an Android-based tablet if the study is supported by Tübitak 1002 A Rapid Support Module. Individual smartphones of participants will be used if the study is not supported. All questionnaires, scales, and tests used in the initial assessments will be repeated at the end of the 8-week exercise protocol for all participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: exerciseReceiving the Otago exercise program |
| Study group 1 | Experimental | Behavioral: exerciseReceiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program |
| Study group 2 | Experimental | Behavioral: exerciseReceiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- To be aged 65 years and older.
- To have the ability to speak, read, comprehend, and write in Turkish.
- To have a body mass index <35 kg/m2 (not being severely or morbidly obese).
- To have experienced one or more falls within the past 1 year.
- To possess cognitive abilities enabling the understanding and implementation of the educational sessions to be conducted in the study (having scored ≥ 24 points on the Mini-Mental State Examination).
Key exclusion criteria (5 listed)
- To have absolute contraindications for strength and aerobic exercises.
- To have chronic pain in the lower body and extremities.
- To have a disorder related to the vestibular system.
- To engage in regular exercise that may affect performance outcomes.
- To decline participation in the study.
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 |
|---|---|---|
| exerciseIn the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method. | Behavioural | Control group, Study group 1, Study group 2 |
Primary outcome
Mini BESTest
Time frame: 15 minutes
Mini Balance Evaluation Systems Test
2 secondary outcomes
Functional Reach Test
Time frame: 3 minutes
International Falls Efficacy Scale
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Geriatrics and Balance, run by Muğla Sıtkı Koçman University.
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 12 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 GİZEM MURAT, MSc (05398408195, gizemmurat@mu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini BESTest (time frame: 15 minutes). 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 20 Feb 2024.