Sarcopenia in ElderlyOPEP-SARCOBALNCT07689903
The Study, Conducted With 54 Individuals Over the Age of 65, Aimed to Reveal the Advantages and Disadvantages of a Combined Exercise Program Compared to Otago Exercise Alone.
A study testing Proprioception Exercise and Exercise Intervention in people with Sarcopenia in Elderly, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Falls are a leading cause of morbidity and mortality in older adults. Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- Proprioception Exercise and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 6 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 65 years of age or older,
- Able to speak and understand Turkish,
- Have at least a primary school education,
- Be able to respond to simple verbal commands.
Who cannot join
- Serious musculoskeletal pathology that may affect proprioception (advanced rheumatoid arthritis, severe osteoarthritis, major joint deformity, etc.), Major neurological or systemic disease that may affect proprioception (diabetic neuropathy, Vascular insufficiency, Post-stroke hemiplegia, Parkinson's disease, Inability to respond to commands due to cognitive dysfunction (SMMT <18 points), Severe visual or hearing loss, Lower extremity amputation or having undergone major lower extremity surgery within the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Otago Plus Proprioceptive Exercises for Sarcopenia, Frailty, Reaction Time, Balance, Falls, and Physical Performance in Geriatric Individuals
Falls are a leading cause of morbidity and mortality in older adults.
Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury.
Read more
Balance disorders, decreased muscle strength, prolonged reaction time, and decreased proprioception are key factors that increase the risk of falls.
One evidence-based intervention to reduce the risk of falls is the Otago Exercise Program, originating in New Zealand.
The program includes strength and balance exercises progressed with ankle weights and walking activities, and has been shown to significantly reduce the incidence of falls in older adults.
Proprioceptive exercises aim to stimulate the sensory system responsible for body position perception and movement control. These exercises contribute to improved balance by enhancing sensorimotor integration.
Although the literature shows positive effects of Otago and proprioceptive exercise programs separately, studies comparing the effectiveness of combining these two approaches on sarcopenia, frailty, balance, falls, reaction time, and physical performance parameters are limited.
The aim of this study is to comparatively evaluate the effects of the Otago exercise program and a program combining Otago and proprioceptive exercises on sarcopenia, frailty, reaction time, balance, falls, and physical performance in geriatric individuals.
It is expected that the findings will contribute to more effective and goal-oriented planning of exercise programs in the geriatric population.
Read the detailed description
The proportion of the elderly population is rapidly increasing worldwide and in Türkiye. According to United Nations data, the population aged 60 and over is expected to exceed 2 billion by 2050. Turkish Statistical Institute projections also foresee that the proportion of the elderly population in our country will reach 20.8% in 2050. This demographic transformation makes the prevention and management of age-related health problems a priority from a public health perspective. Aging is accompanied by a decrease in physiological reserves, an increase in the incidence of multimorbidity, and a decline in functional capacity. One of the important clinical syndromes that stands out in this process is sarcopenia, characterized by progressive decrease in muscle mass and muscle function . Sarcopenia is strongly associated with fall risk, functional decline, frailty, and increased mortality. Fragility is defined as a state of vulnerability to stress resulting from a loss of reserves in multiple physiological systems, predisposing the elderly individual to negative health outcomes. Falls are one of the leading causes of morbidity and mortality in the elderly. Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury. Balance disorders, decreased muscle strength, prolonged reaction time, and decreased proprioception are key factors that increase the risk of falls. One evidence-based intervention to reduce the risk of falls is the Otago Exercise Program, originating in New Zealand. The program includes strength and balance exercises progressing with ankle weights and walking activities, and has been shown to significantly reduce the incidence of falls in elderly individuals. Proprioceptive exercises, on the other hand, aim to stimulate the sensory system responsible for body position perception and movement control. These exercises contribute to improved balance by enhancing sensorimotor integration. Although the literature shows positive effects of Otago and proprioceptive exercise programs separately, studies comparing the effectiveness of combining these two approaches on sarcopenia, frailty, balance, falls, reaction time, and physical performance parameters are limited. The aim of this study is to comparatively evaluate the effects of the Otago exercise program and a program combining Otago and proprioceptive exercises on sarcopenia, frailty, reaction time, balance, falls, and physical performance in geriatric individuals. The findings are expected to contribute to the more effective and goal-oriented planning of exercise programs in the geriatric population.
- Conditions
- Sarcopenia in Elderly
- Being tested
- Proprioception Exercise, Exercise Intervention
- Keywords
- Otago Exercise Program, Geriatric Rehabilitation, Aged, Fraility, Reaction Time, Proprioception, Falls, Sarcopenia, Postural Balance
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioception ExerciseCombination product
Also called Otago Exercise Programme
As an intervention, participants were given exercises to improve their proprioception (sense of joint position, sense of movement, etc.) in addition to the otago exercises.
There are no studies in the literature that combine proprioceptive exercises with otago exercises. In our study, we applied these combined exercises for the first time.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No exercise program was applied to the patients in this group. Only sequential measurements were taken and the results were compared with other groups. |
| Otago Exercise Group | Experimental | Only patients in this group received the Otago Exercise Program. Receives: Other: Exercise Intervention |
| OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES | Experimental | Patients in this group received a proprioceptive exercise program in conjunction with the Otago Exercise Program. Receives: Combination Product: Proprioception Exercise; Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frailty Measured by the Edmonton Frailty Scale (EFS)
The Edmonton Frailty Scale (EFS) assesses 9 domains (cognition, general health, functional independence, social support, medication use, nutrition, mood, continence, functional performance). Total score ranges from 0 (not frail) to 17 (very severe frailty). Assessments conducted at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Measured: From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Muscle Strength Measured by Hand Grip and Knee Extension Dynamometry
Hand grip strength measured in kilograms (kg) using a hand dynamometer. Knee extension strength measured in kilograms (kg) using a hand-held dynamometer. Assessments conducted at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Measured: From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Physical Performance Measured by the 4-Meter Walking Speed Test
Time (in seconds) to walk 4 meters at usual pace. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Measured: From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Muscle Mass Measured by Gastrocnemius-Soleus Circumference
Calf circumference measured in centimeters (cm) using a tape measure at the maximal girth of the gastrocnemius-soleus complex. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Measured: From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Reaction Time Measured by the Nelson Hand and Foot Reaction Test
Reaction time measured in milliseconds (ms) using the Nelson Hand and Foot Reaction Test. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Measured: From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Peripheral Sensation Measured by Semmes-Weinstein Monofilament Test
Monofilament filament size (log10 force in mg) at which sensation is detected on the foot. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Measured: From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Balance and Falls Measured by Number of Falls and Balance Testing
Falls recorded as total number of falls per participant over 6 weeks. Balance assessed using a validated balance scale (e.g., Berg Balance Scale or Timed Up and Go test in seconds). Assessed at baseline (week 0), interim (week 3), and final (week 6).
Measured: From enrollment to the end of treatment at 6 weeks (18 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Apr 2023
- Primary completion31 Dec 2025
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Mesut Uludag, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689903
- Sponsor's protocol ID
- 6f3d5fcd4f8d
- Acronym
- OPEP-SARCOBAL
- Status last verified
- Jul 2026
- First submitted
- 20 Jan 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Otago Plus Proprioceptive Exercises for Sarcopenia, Frailty, Reaction Time, Balance, Falls, and Physical Performance in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT07689903
- Acronym / sponsor ID
- OPEP-SARCOBAL / 6f3d5fcd4f8d
- Conditions
- Sarcopenia in Elderly
- Keywords
- Otago Exercise Program, Geriatric Rehabilitation, Aged, Fraility, Reaction Time, Proprioception, Falls, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 8 Jul 2026 (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.
Falls are a leading cause of morbidity and mortality in older adults.
Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury.
Balance disorders, decreased muscle strength, prolonged reaction time, and decreased proprioception are key factors that increase the risk of falls.
One evidence-based intervention to reduce the risk of falls is the Otago Exercise Program, originating in New Zealand.
The program includes strength and balance exercises progressed with ankle weights and walking activities, and has been shown to significantly reduce the incidence of falls in older adults.
Proprioceptive exercises aim to stimulate the sensory system responsible for body position perception and movement control. These exercises contribute to improved balance by enhancing sensorimotor integration.
Although the literature shows positive effects of Otago and proprioceptive exercise programs separately, studies comparing the effectiveness of combining these two approaches on sarcopenia, frailty, balance, falls, reaction time, and physical performance parameters are limited.
The aim of this study is to comparatively evaluate the effects of the Otago exercise program and a program combining Otago and proprioceptive exercises on sarcopenia, frailty, reaction time, balance, falls, and physical performance in geriatric individuals.
It is expected that the findings will contribute to more effective and goal-oriented planning of exercise programs in the geriatric population.
Detailed description
The proportion of the elderly population is rapidly increasing worldwide and in Türkiye. According to United Nations data, the population aged 60 and over is expected to exceed 2 billion by 2050. Turkish Statistical Institute projections also foresee that the proportion of the elderly population in our country will reach 20.8% in 2050. This demographic transformation makes the prevention and management of age-related health problems a priority from a public health perspective. Aging is accompanied by a decrease in physiological reserves, an increase in the incidence of multimorbidity, and a decline in functional capacity. One of the important clinical syndromes that stands out in this process is sarcopenia, characterized by progressive decrease in muscle mass and muscle function . Sarcopenia is strongly associated with fall risk, functional decline, frailty, and increased mortality. Fragility is defined as a state of vulnerability to stress resulting from a loss of reserves in multiple physiological systems, predisposing the elderly individual to negative health outcomes. Falls are one of the leading causes of morbidity and mortality in the elderly. Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury. Balance disorders, decreased muscle strength, prolonged reaction time, and decreased proprioception are key factors that increase the risk of falls. One evidence-based intervention to reduce the risk of falls is the Otago Exercise Program, originating in New Zealand. The program includes strength and balance exercises progressing with ankle weights and walking activities, and has been shown to significantly reduce the incidence of falls in elderly individuals. Proprioceptive exercises, on the other hand, aim to stimulate the sensory system responsible for body position perception and movement control. These exercises contribute to improved balance by enhancing sensorimotor integration. Although the literature shows positive effects of Otago and proprioceptive exercise programs separately, studies comparing the effectiveness of combining these two approaches on sarcopenia, frailty, balance, falls, reaction time, and physical performance parameters are limited. The aim of this study is to comparatively evaluate the effects of the Otago exercise program and a program combining Otago and proprioceptive exercises on sarcopenia, frailty, reaction time, balance, falls, and physical performance in geriatric individuals. The findings are expected to contribute to the more effective and goal-oriented planning of exercise programs in the geriatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No exercise program was applied to the patients in this group. Only sequential measurements were taken and the results were compared with other groups. |
| Otago Exercise Group | Experimental | Other: Exercise InterventionOnly patients in this group received the Otago Exercise Program. |
| OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES | Experimental | Combination Product: Proprioception Exercise, Other: Exercise InterventionPatients in this group received a proprioceptive exercise program in conjunction with the Otago Exercise Program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years of age or older,
- Able to speak and understand Turkish,
- Have at least a primary school education,
- Be able to respond to simple verbal commands.
Key exclusion criteria (1 listed)
- Serious musculoskeletal pathology that may affect proprioception (advanced rheumatoid arthritis, severe osteoarthritis, major joint deformity, etc.), Major neurological or systemic disease that may affect proprioception (diabetic neuropathy, Vascular insufficiency, Post-stroke hemiplegia, Parkinson's disease, Inability to respond to commands due to cognitive dysfunction (SMMT <18 points), Severe visual or hearing loss, Lower extremity amputation or having undergone major lower extremity surgery within the last year.
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 |
|---|---|---|
| Proprioception ExerciseAlso: Otago Exercise ProgrammeAs an intervention, participants were given exercises to improve their proprioception (sense of joint position, sense of movement, etc.) in addition to the otago exercises. | Combination product | OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES |
| Exercise InterventionThere are no studies in the literature that combine proprioceptive exercises with otago exercises. In our study, we applied these combined exercises for the first time. | Other | OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES, Otago Exercise Group |
Primary outcome
Change in Frailty Measured by the Edmonton Frailty Scale (EFS)
Time frame: From enrollment to the end of treatment at 6 weeks (18 sessions)
The Edmonton Frailty Scale (EFS) assesses 9 domains (cognition, general health, functional independence, social support, medication use, nutrition, mood, continence, functional performance). Total score ranges from 0 (not frail) to 17 (very severe frailty). Assessments conducted at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Change in Muscle Strength Measured by Hand Grip and Knee Extension Dynamometry
Time frame: From enrollment to the end of treatment at 6 weeks (18 sessions)
Hand grip strength measured in kilograms (kg) using a hand dynamometer. Knee extension strength measured in kilograms (kg) using a hand-held dynamometer. Assessments conducted at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Change in Physical Performance Measured by the 4-Meter Walking Speed Test
Time frame: From enrollment to the end of treatment at 6 weeks (18 sessions)
Time (in seconds) to walk 4 meters at usual pace. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Change in Muscle Mass Measured by Gastrocnemius-Soleus Circumference
Time frame: From enrollment to the end of treatment at 6 weeks (18 sessions)
Calf circumference measured in centimeters (cm) using a tape measure at the maximal girth of the gastrocnemius-soleus complex. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Change in Reaction Time Measured by the Nelson Hand and Foot Reaction Test
Time frame: From enrollment to the end of treatment at 6 weeks (18 sessions)
Reaction time measured in milliseconds (ms) using the Nelson Hand and Foot Reaction Test. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Change in Peripheral Sensation Measured by Semmes-Weinstein Monofilament Test
Time frame: From enrollment to the end of treatment at 6 weeks (18 sessions)
Monofilament filament size (log10 force in mg) at which sensation is detected on the foot. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
Change in Balance and Falls Measured by Number of Falls and Balance Testing
Time frame: From enrollment to the end of treatment at 6 weeks (18 sessions)
Falls recorded as total number of falls per participant over 6 weeks. Balance assessed using a validated balance scale (e.g., Berg Balance Scale or Timed Up and Go test in seconds). Assessed at baseline (week 0), interim (week 3), and final (week 6).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- This can help in understanding the working protocol.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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 Proprioception Exercise and Exercise Intervention in people with Sarcopenia in Elderly, run by Hacettepe 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Frailty Measured by the Edmonton Frailty Scale (EFS) (time frame: From enrollment to the end of treatment at 6 weeks (18 sessions)). 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 8 Jul 2026.