Effect of Physical-Cognitive Training in Older Adults

NCT ID: NCT07199426

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2026-08-28

Brief Summary

The study compares the impact of physical-cognitive exercises using Blazepod device versus conventional balance training on multiple outcomes in older adults aged 70 and above. Participants receive an 8-week intervention, three sessions per week for both groups. Outcome measures include balance assessments, fear of falling scales, activity of daily living performance, sleep quality questionnaires, reaction time tests, and cognitive assessments. The study aims to determine whether physical-cognitive training provides additional benefits compared to conventional balance exercises.

Detailed Description

Worldwide and in Turkey, increasing life expectancy and the growth of the elderly population are associated with rising care, health, and social needs among older adults. Aging induces physiological changes that lead to declines in both physical and cognitive capacities. Recently, non-pharmacological interventions have gained importance over pharmacological treatments to improve function and avoid polypharmacy. Strength, aerobic, and balance exercises have been shown to induce structural and functional brain adaptations, increase BDNF secretion, and positively influence both physical and cognitive domains.

Systematic reviews suggest that combining cognitive training with physical exercises produces greater cognitive benefits than physical exercises alone. Conventional balance training programs for healthy older adults are widely reported in the literature, often including static and dynamic exercises performed with eyes open or closed. These exercises improve balance, reduce falls, and enhance quality of life.

However, traditional balance exercises may have limitations due to the absence of visual stimuli or reduced environmental challenges, which can limit their transfer to real-life daily activities. Recently, combined physical-cognitive training programs have gained attention.

The Blazepod system, controlled via a smartphone application, provides visual stimuli through LED lights to train reaction time and skill acquisition, while engaging both physical and cognitive processes simultaneously. Unlike conventional programs, Blazepod allows unpredictable sequences of stimuli, requiring participants to respond in real time, thus activating both physical and cognitive skills.

The aim of this study is to investigate the effects of simultaneous physical-cognitive training using Blazepod and conventional balance exercises on cognitive function, balance, daily activity performance, fall risk, and sleep quality in older adults.

This study will include two groups of participants aged 70 years and older with a Mini-Mental State Examination (MMSE) score of 24 or higher who are able to walk independently. Each group will include 17 participants, for a total of 34 participants. Both groups will participate in an 8-week intervention, three sessions per week.

In the physical-cognitive exercise group, each session will begin with a warm-up period including strengthening and mobilization exercises, followed by a Blazepod-based exercise program designed to simultaneously train balance and cognitive skills. Each session will conclude with a cool-down program including stretching and breathing exercises.

In the balance exercise group, sessions will follow the same structure: after warm-up exercises, participants will perform conventional balance exercises, followed by the same cool-down program as the physical-cognitive group.

Conditions

Older Adults, Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical-Cognitive Training Group

Blazepod-based physical-cognitive training (8 weeks, 3 sessions/week)

Group Type: EXPERIMENTAL

Physical-Cognitive Training

Intervention Type: OTHER

Participants will receive an 8-week physical-cognitive training program using the Blazepod device, consisting of exercises targeting both balance and cognitive skills. Sessions will be conducted three times per week, each lasting one hour.

Conventional Balance Training Group

Conventional balance training (8 weeks, 3 sessions/week)

Group Type: ACTIVE_COMPARATOR

Conventional Balance Training

Intervention Type: OTHER

Participants will receive an 8-week conventional balance training program. Sessions will be conducted three times per week, each lasting one hour.

Interventions

Physical-Cognitive Training

Participants will receive an 8-week physical-cognitive training program using the Blazepod device, consisting of exercises targeting both balance and cognitive skills. Sessions will be conducted three times per week, each lasting one hour.

Intervention Type: OTHER

Conventional Balance Training

Participants will receive an 8-week conventional balance training program. Sessions will be conducted three times per week, each lasting one hour.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Score of 24 or higher on the Standardized Mini-Mental State Examination (MMSE)
• Ability to walk independently without assistance
• Willingness to provide written informed consent

Exclusion Criteria

• Participation in another clinical study during the study period
• Presence of neurological or psychiatric diagnoses
• Conditions that impair walking or mobility
• Uncontrolled hypertension or cardiovascular disease

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Gözde Baş Başer

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Gözde Baş Başer

Role: CONTACT

gozde.bas@std.medipol.edu.tr

+905385460124

Facility Contacts

Gözde Baş Başer, MSc

Role: primary

gozde.bas@std.medipol.edu.tr

+905385460124

Other Identifiers

MU-FTR-GBB-01

Identifier Type: -

Identifier Source: org_study_id