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.

NCT07689903 | Active Not Recruiting DMC

• 1 other identifier: 6f3d5fcd4f8d
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia in Elderly

Keywords

Otago Exercise Program; Geriatric Rehabilitation; Aged; Fraility; Reaction Time; Proprioception; Falls; Sarcopenia; Postural Balance

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

  From enrollment to the end of treatment at 6 weeks (18 sessions)

Study Arms (3)

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.

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.

Combination Product: Proprioception Exercise; Other: Exercise Intervention

Interventions

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.

Also known as: Otago Exercise Programme

OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES

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.

OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES; Otago Exercise Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead
• Baskent University: collaborator

Study Sites (1)

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Location

Related Links

• This can help in understanding the working protocol.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Leader

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: July 8, 2026
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 6, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: only IPD used in the results publication
• Access Criteria: researchers

Locations

TU (1)