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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)

1. července 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

54

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: 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.
Experimentální: Otago Exercise Group
Only patients in this group received the Otago Exercise Program.
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.
Experimentální: OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES
Patients in this group received a proprioceptive exercise program in conjunction with the Otago Exercise Program.
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.
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.
Ostatní jména:
  • Otago Exercise Programme

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Frailty Measured by the Edmonton Frailty Scale (EFS)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. dubna 2023

Primární dokončení (Aktuální)

31. prosince 2025

Dokončení studie (Odhadovaný)

6. října 2026

Termíny zápisu do studia

První předloženo

20. ledna 2026

První předloženo, které splnilo kritéria kontroly kvality

1. července 2026

První zveřejněno (Aktuální)

8. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Časový rámec sdílení IPD

only IPD used in the results publication

Kritéria přístupu pro sdílení IPD

researchers

Typ podpůrných informací pro sdílení IPD

  • CSR

Studijní data/dokumenty

  1. Protokol studie
    Komentáře k informacím: https://etikkurul.karatekin.edu.tr/dogrulama/6f3d5fcd4f8d4a2e / https://sbetikkurul.karatekin.edu.tr/

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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