NCT07870486

Brief Summary

The Otago Exercise Programme is a multicomponent exercise approach targeting strength, balance, and mobility in older adults. Short-foot exercises are designed to improve intrinsic foot muscle activation and medial longitudinal arch control. This randomized comparative study will investigate whether adding short-foot exercises to the Otago Exercise Programme provides additional benefits in older adults.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 13, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

October 30, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

October 14, 2026

Status Verified

October 1, 2026

Enrollment Period

6 months

First QC Date

October 6, 2026

Last Update Submit

October 13, 2026

Conditions

Keywords

Older AdultsBalanceJoint Position SenseMuscle StrengthFear of FallingFoot Posture

Outcome Measures

Primary Outcomes (1)

  • Five Times Sit-to-Stand Test (5STS

    Lower-extremity functional capacity will be assessed using the Five Times Sit-to-Stand Test (5STS). Participants will sit on a standard-height chair without armrests, with the arms crossed over the chest, and will be instructed to stand up fully and sit down five consecutive times as quickly as possible. The time from initiation of the first stand to completion of the fifth sitting will be recorded in seconds. Lower completion times indicate better functional performance

    Baseline (pre-intervention) and immediately post-intervention (Week 8).

Secondary Outcomes (5)

  • Dynamic Balance - Mini-BESTest

    aseline (pre-intervention) and immediately post-intervention (Week 8).

  • Ankle Joint Position Sense

    Baseline (pre-intervention) and immediately post-intervention (Week 8).

  • Ankle Muscle Strength

    Baseline (pre-intervention) and immediately post-intervention (Week 8).

  • Falls Efficacy Scale-International (FES-I)

    Baseline (pre-intervention) and immediately post-intervention (Week 8).

  • Navicular Drop Test

    Baseline (pre-intervention) and immediately post-intervention (Week 8).

Study Arms (2)

Otago Exercise Programme

EXPERIMENTAL

Participants in this arm will receive a supervised Otago Exercise Programme for 8 weeks, with 2 sessions per week. Each 50-minute session will consist of 5 minutes of warm-up, 40 minutes of Otago exercises, and 5 minutes of cool-down. The Otago component will include lower extremity strengthening, static and dynamic balance exercises, and functional balance and walking tasks. Exercise difficulty will be progressively adjusted according to individual performance and safety.

Behavioral: Otago Exercise Programme

Otago Exercise Programme + Short-Foot Exercise

EXPERIMENTAL

Participants in this arm will receive the Otago Exercise Programme combined with Short-Foot Exercises for 8 weeks, with 2 supervised sessions per week. Each 60-minute session will include 5 minutes of warm-up, 10 minutes of Short-Foot Exercises, 40 minutes of Otago exercises, and 5 minutes of cool-down. Short-Foot Exercises will target intrinsic foot muscle activation and medial longitudinal arch control by drawing the first metatarsal head toward the heel without toe flexion. Exercises will progress from sitting to standing, mini-squat, and soft-surface standing. Three blocks of 12 repetitions will be performed, with each contraction held for 5 seconds and 2 minutes of rest between blocks.

Behavioral: Otago Exercise Programme + Short-Foot Exercise

Interventions

The Otago Exercise Programme will be delivered under physiotherapist supervision for 8 weeks, 2 days per week, for a total of 16 sessions. Each session will last 50 minutes and will include warm-up, lower extremity strengthening, static and dynamic balance exercises, functional balance and walking tasks, and cool-down. Exercises will be progressively adjusted according to participant performance and safety.

Otago Exercise Programme

The combined intervention will be delivered under physiotherapist supervision for 8 weeks, 2 days per week, for a total of 16 sessions. Each 60-minute session will include 5 minutes of warm-up, 10 minutes of Short-Foot Exercises, 40 minutes of Otago exercises, and 5 minutes of cool-down. Short-Foot Exercises will target intrinsic foot muscle activation and medial longitudinal arch control and will progress from sitting to standing, mini-squat, and soft-surface standing according to participant performance.

Otago Exercise Programme + Short-Foot Exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Willing to participate and provide written informed consent.
  • Aged 65 years or older.
  • Residing in the nursing home where the study will be conducted for at least 3 months.
  • Able to understand and follow test instructions, with a Standardized Mini-Mental Test score ≥24.
  • Able to walk at least 30 meters without physical assistance from another person.
  • Able to stand with eyes open for at least 30 seconds and safely complete sit-to-stand and balance assessments.
  • Able to perform the target ankle dorsiflexion and plantar flexion angles without pain or marked restriction of active range of motion.
  • Navicular Drop Test result between 6 and 9 mm.

You may not qualify if:

  • History of neurological or neurodegenerative disease that may substantially affect postural control, proprioception, or motor responses, including stroke sequelae, Parkinson's disease, multiple sclerosis, advanced dementia, or marked cerebellar disorders.
  • Cardiopulmonary, vestibular, or systemic disease that may prevent safe completion of the interventions or assessments.
  • Diagnosed peripheral neuropathy, marked lower-extremity sensory loss, or diabetic neuropathy.
  • Use of an assistive device.
  • Lower-extremity amputation, prosthesis use, or severe structural deformity interfering with foot or ankle assessment.
  • Pain, instability, or severe range-of-motion limitation in the ankle, knee, or hip that prevents completion of the tests.
  • History of lower-extremity fracture, surgery, or major trauma within the previous 6 months.
  • Musculoskeletal injury of the foot, ankle, or lower extremity within the previous 3 months that limits participation in functional testing.
  • Open wound, ulcer, active skin lesion, or infection in the foot or ankle region that interferes with sensor or measurement placement.
  • Recent initiation of, or dose change in, medication that may affect balance, alertness, or motor performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Horsunlu Nursing Home Care and Rehabilitation Center

Aydin, Turkey (Türkiye)

Location

Study Officials

  • Tuba Can Akman, PhD

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Müge İçelli Güneş, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, two-arm, parallel-group trial. Participants will be randomly assigned to either the Otago Exercise Programme group or the Otago Exercise Programme combined with Short-Foot Exercise group. Interventions will be delivered for 8 weeks, with 2 supervised sessions per week. Outcomes will be assessed at baseline and post-intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 13, 2026

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

October 14, 2026

Record last verified: 2026-10

Locations