NCT06700928

Brief Summary

The ability to walk safely and efficiently is crucial for older adults to maintain their independence and minimize the risk of falls. In healthy geriatric individuals, walking typically occurs as an automatic process involving motor skills, meaning the movement is generally performed with minimal conscious thought. However, attention can influence motor performance; a lack of focus or distraction can lead to loss of balance and increase the risk of falling during walking. The effects of attention focus on geriatric individuals remain uncertain. Therefore, this study aims to investigate the effects of different attention-focused training on physical performance and cognitive function in geriatric individuals. In this randomized controlled trial, 60 participants will be randomly assigned to four groups: the internal focus exercise group (n = 15), the external focus exercise group (n = 15), the no attention focus group (n = 15), and the control group (n = 15). The control group will consist of participants from a different institution to prevent contamination. Participants in the non-control groups will attend training sessions twice a week (approximately 40 minutes each) for 12 weeks. The experimental groups will complete a total of 24 exercise sessions. All training sessions will be conducted by an experienced physiotherapist. Pre- and post-assessments will be conducted. The sociodemographic characteristics of all participants will be assessed using a descriptive form. Participants' physical performance will be evaluated using the Short Physical Performance Battery (SPPB), the Stair Climbing Test, the Timed Up and Go Test (TUG), a static balance test (single-leg stance test), and a dynamic balance test (Berg Balance Scale). Cognitive function will be assessed using the Central Nervous System Vital Signs (CNSVS) Cognitive Performance and Attention Tests. Additionally, participants' walking will be analyzed using Kinect V2 camera-based software. The data collected from the study will be analyzed using SPSS (Statistical Program for the Social Sciences). Descriptive statistics will include frequencies, percentages, means, and standard deviations. For comparisons, the significance level (p) will be set at 0.05.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Feb 2025

Status
not yet recruiting

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 Progress72%
Feb 2025Nov 2026

First Submitted

Initial submission to the registry

November 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

February 11, 2025

Status Verified

November 1, 2024

Enrollment Period

28 days

First QC Date

November 14, 2024

Last Update Submit

February 7, 2025

Conditions

Keywords

Geriatric individualsAttention focusInternal focusExternal focusPhysical performanceCognitive function

Outcome Measures

Primary Outcomes (2)

  • The Short Physical Performance Battery (SPPB), stair climbing test, Timed Up and Go (TUG) test, Berg balance test, and single leg stance test

    The Short Physical Performance Battery (SPPB), stair climbing test, Timed Up and Go (TUG) test, Berg balance test, and single leg stance test will be used to assess physical performance.

    12 weeks

  • Central Nervous System Vital Signs (CNSVS)

    The "Central Nervous System Vital Signs (CNSVS) Cognitive Performance and Attention Tests" will be administered to assess cognitive functions. CNSVS is an evaluation tool designed to examine the neurocognitive status of individuals aged 7 to 90. It consists of several subtests, including the Verbal Memory Test, Visual Memory Test, Finger Tapping Test, Symbol-Digit Coding Test, Stroop Test, Continuous Performance Test, and Attention Switching Test. In our study, scores obtained from these subtests will be utilized. To determine the extent of neurocognitive impairment, classification is made based on standard score points. According to this classification: \>110 indicates high capacity, 90-110 indicates normal capacity, 80-89 indicates mild cognitive impairment, 70-79 indicates moderate cognitive impairment, and \<70 indicates severe cognitive impairment.

    12 weeks

Secondary Outcomes (1)

  • Gait analysis using Kinect V2

    12 weeks

Study Arms (4)

Internal focus group

EXPERIMENTAL

After obtaining informed consent to participate in the study, all participants, regardless of group, will undergo an assessment by an experienced physiotherapist prior to group allocation. They will participate in exercise sessions lasting approximately 40 minutes, twice a week for 12 weeks in the internal focus group. A total of 24 sessions will be completed by each participant. Exercise sessions will be carried out by an experienced physiotherapist. Each training session will consist of warm-up (5 minutes), balance, transfer and reaching activities (10 minutes), internal focused walking (20 minutes) and cool-down (5 minutes) exercises. The first assessment will be made before the sessions start and the final assessment will be made after the 12-week exercise program.

Other: Internal focus training

External focus group

EXPERIMENTAL

After obtaining informed consent to participate in the study, all participants, regardless of group, will undergo an assessment by an experienced physiotherapist prior to group allocation. They will participate in exercise sessions lasting approximately 40 minutes, twice a week for 12 weeks in the external focus group. A total of 24 sessions will be completed by each participant. Exercise sessions will be carried out by an experienced physiotherapist. Each training session will consist of warm-up (5 minutes), balance, transfer and reaching activities (10 minutes), external focused walking (20 minutes) and cool-down (5 minutes) exercises. The first assessment will be made before the sessions start and the final assessment will be made after the 12-week exercise program.

Other: External focus training

No attention focus group

EXPERIMENTAL

After obtaining informed consent to participate in the study, all participants, regardless of group, will undergo an assessment by an experienced physiotherapist prior to group allocation. They will participate in exercise sessions lasting approximately 40 minutes, twice a week for 12 weeks in the no attention focus group. A total of 24 sessions will be completed by each participant. Exercise sessions will be carried out by an experienced physiotherapist. Each training session will consist of warm-up (5 minutes), balance, transfer and reaching activities (10 minutes), no attentional focus walking (20 minutes) and cool-down (5 minutes) exercises. The first assessment will be made before the sessions start and the final assessment will be made after the 12-week exercise program.

Other: No attentional focus training

Control group

NO INTERVENTION

no-intervention

Interventions

External focus training

External focus group

internal focus training

Internal focus group

no attentional focus training

No attention focus group

Eligibility Criteria

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

You may qualify if:

  • Aged 65 years or older
  • Willingness to participate in the study
  • Ability to read and write
  • Mini-Mental State Examination (MMSE) score \> 24
  • Ability to independently perform the tests administered as part of the study
  • Ability to walk independently in the community (without a walking aid and able to walk at least 40 meters)

You may not qualify if:

  • Presence of orthopedic, neurological, vestibular, cognitive, or other medical conditions that may affect the applicability of the assessment methods or training interventions used in the study
  • History of myocardial infarction and/or coronary bypass surgery within the past year
  • Severe visual or auditory impairments causing communication difficulties
  • Polypharmacy (use of five or more medications per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

MÜŞERREF EBRU ŞEN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 22, 2024

Study Start

February 1, 2025

Primary Completion

March 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

February 11, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

I think the data should be kept confidential.