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NCT Number: NCT07689903

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.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Sarcopenia in Elderly Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proprioception Exercise

Combination Product

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

Exercise intervention

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Baskent University

Registry information

Official study title

Otago Plus Proprioceptive Exercises for Sarcopenia, Frailty, Reaction Time, Balance, Falls, and Physical Performance in Geriatric Individuals

Acronym: OPEP-SARCOBAL

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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