NCT07823166

Brief Summary

This study aimed to compare the effects of motor and cognitive dual-task exercise programs on fall risk, balance, and gait performance in older adults residing in nursing homes.The main question it aims to answer is: An eight-week motor or cognitive dual-task exercise program did not provide additional benefits over standard single-task exercise in improving fall risk, balance, or gait performance in nursing home residents. All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks. Assessments were conducted before and after the intervention using the Five-Repetition Sit-to-Stand Test, 2-Minute Walk Test, Single-Leg Stance Test, Timed Up and Go (TUG) Test, Tinetti Balance and Gait Scale, and Functional Reach Test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 11, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

Dual-task exercisebalanceolder adultsnursing homerehabilitation

Outcome Measures

Primary Outcomes (3)

  • 2-Minute Walk Test (2MWT)

    Walking capacity was assessed over a 30-meter walkway during a two-minute period. Participants wore comfortable clothing and footwear and rested for 10 minutes before testing. The total walking distance was recorded in meters. Distance walked during two minutes, measured in meters. Higher values indicate better walking endurance and functional capacity.

    8 weeks

  • Five Times Sit-to-Stand Test (FTSST)

    The FTSST was used to assess lower extremity strength, functional mobility, and fall risk. Participants were instructed to stand up from a standard chair and sit down five consecutive times as quickly as possible while keeping their arms crossed over the chest. Total completion time was recorded using a stopwatch. Time required to complete five consecutive sit-to-stand movements, measured in seconds. Lower values indicate better lower-extremity functional performance; higher values indicate worse outcome.

    8 weeks

  • Timed Up and Go (TUG) Test

    Functional mobility was assessed by measuring the time required for participants to stand up from a chair, walk 3 meters, turn around, return to the chair, and sit down. Time was recorded in seconds using a stopwatch. Time required to complete the test, measured in seconds. Lower values indicate better mobility and functional performance; higher values indicate worse outcome.

    8 weeks

Secondary Outcomes (3)

  • Single-Leg Stance Test

    8 weeks

  • Tinetti Balance and Gait Assessment Scale

    8 weeks

  • Functional Reach Test

    8 weeks

Study Arms (3)

Motor Dual-Task Exercise Group

EXPERIMENTAL
Behavioral: Motor Dual-Task Exercise

Cognitive Dual-Task Exercise Group

EXPERIMENTAL
Behavioral: Cognitive Dual-Task Exercise

Control Group

ACTIVE COMPARATOR
Behavioral: Control group

Interventions

Participants in the motor dual-task group performed a structured exercise program consisting of the Five Times Sit-to-Stand Test, Timed Up and Go test (3 m), single-leg stance, 10-meter tandem walking, 10-meter normal walking, and a 20-meter marching activity while simultaneously carrying a tray filled with water. All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.

Motor Dual-Task Exercise Group

Participants in the cognitive dual-task group performed the same exercise program combined with a concurrent cognitive task. During each exercise, participants were instructed to verbally generate proper nouns beginning with the letter "A". All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.

Cognitive Dual-Task Exercise Group
Control groupBEHAVIORAL

The control group performed a conventional exercise program of equivalent duration and frequency without any additional dual-task component. All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.

Control Group

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • residing in nursing homes who were aged between 65 and 95 years
  • Individuals able to walk independently
  • Individuals who are literate
  • Individuals willing to participate in the study
  • Individuals cognitively capable of understanding and performing the required assessments and exercises.

You may not qualify if:

  • Individuals with malignancy
  • Individuals with osteoporosis
  • Individuals with a history of fracture
  • Individuals with coagulation disorders
  • Individuals with an active infection
  • Individuals with orthostatic hypotension
  • Individuals with pacemaker implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altınçatı Nursing Home and Elderly Care Center

Ankara, ÇANKAYA, 06550, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • BİHTER AKINOĞLU, Assoc. Prof. Dr., PT.

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
A total of 69 eligible participants were allocated into three groups using a systematic allocation sequence based on the order of enrollment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were sequentially allocated to three parallel groups in a 1:1:1 ratio based on the order of enrollment: motor dual-task exercise, cognitive dual-task exercise, and conventional exercise (control) groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr., PT.

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 16, 2026

Study Start

November 25, 2023

Primary Completion

September 15, 2024

Study Completion

November 25, 2024

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The datasets generated and analyzed during the current study are not publicly available due to ethical and privacy restrictions involving older adult participants residing in nursing homes. The data presented in this study are available on request from the corresponding author.

Locations