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. (OPEP-SARCOBAL)

July 1, 2026 updated by: Mesut Uludag, Hacettepe University

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Altındağ
      • Ankara, Altındağ, Turkey (Türkiye)
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No exercise program was applied to the patients in this group. Only sequential measurements were taken and the results were compared with other groups.
Experimental: Otago Exercise Group
Only patients in this group received the Otago Exercise Program.
Other: Exercise Intervention
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.
Experimental: OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES
Patients in this group received a proprioceptive exercise program in conjunction with the Otago Exercise Program.
Other: Exercise Intervention
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.
Combination product: Proprioception Exercise
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.
Other Names:
  • Otago Exercise Programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 6 weeks (18 sessions)
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.
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 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.
From enrollment to the end of treatment at 6 weeks (18 sessions)
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.
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
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.
From enrollment to the end of treatment at 6 weeks (18 sessions)
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.
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
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).
From enrollment to the end of treatment at 6 weeks (18 sessions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

October 6, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6f3d5fcd4f8d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

only IPD used in the results publication

IPD Sharing Access Criteria

researchers

IPD Sharing Supporting Information Type

  • CSR

Study Data/Documents

  1. Study Protocol
    Information comments: https://etikkurul.karatekin.edu.tr/dogrulama/6f3d5fcd4f8d4a2e / https://sbetikkurul.karatekin.edu.tr/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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