Older Adults, BalanceNCT07199426
Effect of Physical-Cognitive Training in Older Adults
A study testing Physical-Cognitive Training and Conventional Balance Training in people with Older Adults, Balance, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Balance
- What is being tested?
- Physical-Cognitive Training and Conventional Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, Beykoz, 34810
Gözde Baş Başer, MSc, +905385460124, gozde.bas@std.medipol.edu.tr
About this study
Official title: The Effect of Physical-Cognitive Training on Balance and Falls in Older Adults
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.
Read the 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
- Being tested
- Physical-Cognitive Training, Conventional Balance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical-Cognitive TrainingOther
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 TrainingOther
Participants will receive an 8-week conventional balance training program. Sessions will be conducted three times per week, each lasting one hour.
| Study group | Role | What they receive |
|---|---|---|
| Physical-Cognitive Training Group | Experimental | Blazepod-based physical-cognitive training (8 weeks, 3 sessions/week) Receives: Other: Physical-Cognitive Training |
| Conventional Balance Training Group | Active comparator | Conventional balance training (8 weeks, 3 sessions/week) Receives: Other: Conventional Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standartized Mini Mental Test
It is a test used to assess cognitive impairment and changes, scored out of 30 points, with scores below 24 indicating potential dementia.
Measured: From enrollment to the end of treatment at 8 weeks
Montreal Cognitive Assessment
A brief cognitive screening tool evaluating memory, attention, language, visuospatial skills, and executive function. Scores below 26 suggest possible cognitive impairment.
Measured: From enrollment to the end of treatment at 8 weeks
Fullerton Advanced Balance Scale
A clinical balance assessment consisting of 10 tasks that test static and dynamic balance, anticipatory postural adjustments, and sensory integration. Total score is changed 0-40 and higher scores indicated better balance.
Measured: From enrollment to the end of treatment at 8 weeks
Functional Reach Test
Assesses the maximal distance a person can reach forward beyond arm's length while maintaining a fixed base of support. Measures dynamic balance and risk of falling.
Measured: From enrollment to the end of treatment at 8 weeks
Timed Up and Go Test
Measures the time taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Evaluates mobility, balance and fall risk.
Measured: From enrollment to the end of treatment at 8 weeks
Modified Falls Efficacy Scale
Assesses fear of falling and confidence in performing daily activities. A self-reported questionnaire measuring perceived confidence in avoiding falls during various daily activities.
Measured: From enrollment to the end of treatment at 8 weeks
Deary-Liewald Reaction Time Task
Evaluates simple and choice reaction time. A computerized test measuring the speed of cognitive-motor responses to visual stimuli.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (3)
Katz Index of Independence in Activities of Daily Living
Evaluates independence in six daily activities: bathing, dressing, toileting, transferring, continence, and feeding. Higher scores indicate greater independence.
Measured: From enrollment to the end of treatment at 8 weeks
Lawton Instrumental Activities of Daily Living Scale
Assesses more complex daily living skills. Measures ability to perform tasks such as using the telephone, shopping, preparing meals, housekeeping, laundry, transportation, medication management, and handling finances. Higher scores indicate greater functional ability, and score is between 0-17.
Measured: From enrollment to the end of treatment at 8 weeks
Pittsburgh Sleep Quality Index
Assess sleep quality and disturbances. A self-reported questionnaire evaluating sleep quality over the past month, including components such as sleep duration, latency, efficiency, disturbances, and daytime dysfunction. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start18 Aug 2025
- Primary completion18 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults, BalanceStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Baş Başer, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199426
- Sponsor's protocol ID
- MU-FTR-GBB-01
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical-Cognitive Training on Balance and Falls in Older Adults
- ClinicalTrials.gov ID
- NCT07199426
- Acronym / sponsor ID
- MU-FTR-GBB-01
- Conditions
- Older Adults, Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 18 Aug 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical-Cognitive Training Group | Experimental | Other: Physical-Cognitive TrainingBlazepod-based physical-cognitive training (8 weeks, 3 sessions/week) |
| Conventional Balance Training Group | Active comparator | Other: Conventional Balance TrainingConventional balance training (8 weeks, 3 sessions/week) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical-Cognitive TrainingParticipants 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. | Other | Physical-Cognitive Training Group |
| Conventional Balance TrainingParticipants will receive an 8-week conventional balance training program. Sessions will be conducted three times per week, each lasting one hour. | Other | Conventional Balance Training Group |
Primary outcome
Standartized Mini Mental Test
Time frame: From enrollment to the end of treatment at 8 weeks
It is a test used to assess cognitive impairment and changes, scored out of 30 points, with scores below 24 indicating potential dementia.
Montreal Cognitive Assessment
Time frame: From enrollment to the end of treatment at 8 weeks
A brief cognitive screening tool evaluating memory, attention, language, visuospatial skills, and executive function. Scores below 26 suggest possible cognitive impairment.
Fullerton Advanced Balance Scale
Time frame: From enrollment to the end of treatment at 8 weeks
A clinical balance assessment consisting of 10 tasks that test static and dynamic balance, anticipatory postural adjustments, and sensory integration. Total score is changed 0-40 and higher scores indicated better balance.
Functional Reach Test
Time frame: From enrollment to the end of treatment at 8 weeks
Assesses the maximal distance a person can reach forward beyond arm's length while maintaining a fixed base of support. Measures dynamic balance and risk of falling.
Timed Up and Go Test
Time frame: From enrollment to the end of treatment at 8 weeks
Measures the time taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Evaluates mobility, balance and fall risk.
Modified Falls Efficacy Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Assesses fear of falling and confidence in performing daily activities. A self-reported questionnaire measuring perceived confidence in avoiding falls during various daily activities.
Deary-Liewald Reaction Time Task
Time frame: From enrollment to the end of treatment at 8 weeks
Evaluates simple and choice reaction time. A computerized test measuring the speed of cognitive-motor responses to visual stimuli.
3 secondary outcomes
Katz Index of Independence in Activities of Daily Living
Time frame: From enrollment to the end of treatment at 8 weeks
Lawton Instrumental Activities of Daily Living Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Pittsburgh Sleep Quality Index
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical-Cognitive Training and Conventional Balance Training in people with Older Adults, Balance, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gözde Baş Başer (+905385460124, gozde.bas@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standartized Mini Mental Test (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.