- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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. (OPEP-SARCOBAL)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Altındağ
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Ankara, Altındağ, Turchia (Türkiye)
- Hacettepe University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: 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.
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Sperimentale: Otago Exercise Group
Only patients in this group received the Otago Exercise Program.
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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.
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Sperimentale: OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES
Patients in this group received a proprioceptive exercise program in conjunction with the Otago Exercise Program.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Frailty Measured by the Edmonton Frailty Scale (EFS)
Lasso di tempo: From enrollment to the end of treatment at 6 weeks (18 sessions)
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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.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Muscle Strength Measured by Hand Grip and Knee Extension Dynamometry
Lasso di tempo: 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.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Physical Performance Measured by the 4-Meter Walking Speed Test
Lasso di tempo: 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.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Muscle Mass Measured by Gastrocnemius-Soleus Circumference
Lasso di tempo: 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.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Reaction Time Measured by the Nelson Hand and Foot Reaction Test
Lasso di tempo: 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.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Peripheral Sensation Measured by Semmes-Weinstein Monofilament Test
Lasso di tempo: 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.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Balance and Falls Measured by Number of Falls and Balance Testing
Lasso di tempo: From enrollment to the end of treatment at 6 weeks (18 sessions)
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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).
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 6f3d5fcd4f8d
Piano per i dati dei singoli partecipanti (IPD)
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Periodo di condivisione IPD
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Tipo di informazioni di supporto alla condivisione IPD
- RSI
Dati/documenti di studio
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Protocollo di studio
Commenti informativi: https://etikkurul.karatekin.edu.tr/dogrulama/6f3d5fcd4f8d4a2e / https://sbetikkurul.karatekin.edu.tr/
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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