Cognitive DeclineZZ-MINDNCT07244848
Zinde Zihin Program to Reduce Alzheimer's Disease Risk in Adults Aged 65 and Older
A study testing Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention in people with Cognitive Decline and Aging, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the feasibility and implementation of the Zinde Zihin ("Fit Mind") multidomain lifestyle program for older adults aged 65 years and older living in public nursing homes. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Aging, Alzheimer Disease
- What is being tested?
- Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ages Eligible for Study:
- 65 Years to 80 Years (Older Adult)
- Sexes Eligible for Study:
- All
- Accepts Healthy Volunteers:
- Yes
Who cannot join
- Diagnosis of dementia or severe cognitive impairment.
- History of depression or major psychiatric disorder.
- Physical disability or medical condition prevents participation in exercise.
- Attendance in less than two-thirds of the planned intervention sessions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University Faculty of Health Science
Burdur, 15030
About this study
Official title: Effects of the Zinde Zihin Multidomain Lifestyle Program on Alzheimer's Disease Risk: A Two-Center Controlled Intervention Study
This study aims to evaluate the feasibility and implementation of the Zinde Zihin ("Fit Mind") multidomain lifestyle program for older adults aged 65 years and older living in public nursing homes. The program includes cognitive activities, physical exercises, nutrition education, psychosocial engagement, sleep education, and stress-management components delivered in eight structured sessions over four weeks. The primary objective is to examine changes in Alzheimer's Disease Risk Index-Short Form (ANU-ADRI-SF) scores from baseline to post-intervention. Secondary objectives include assessing changes in cognitive activity engagement and affect-related lifestyle factors.
Read the detailed description
The Zinde Zihin ("Fit Mind") Program is a multidomain lifestyle intervention designed to promote healthy cognitive aging among older adults. The intervention integrates cognitive training, physical activity, nutritional education, psychosocial engagement, and sleep/stress management techniques within a group-based framework. The program is delivered in eight structured sessions over four weeks, with each session lasting approximately 60-75 minutes.
Study Rationale Lifestyle factors such as cognitive stimulation, physical activity, sleep, and social engagement play an important role in cognitive health. Multidomain interventions involving these components may support healthy aging. This study was developed to examine the feasibility of such an intervention in Turkish nursing home settings.
Study Design This is an individually randomized, controlled pretest-posttest study conducted in two public nursing homes. Randomization is performed at the individual level after eligibility screening. The protocol follows CONSORT guidelines for individually randomized trials.
Participants Eligible participants are adults aged 65 years or older with a Mini-Mental State Examination (MMSE) score ≥23 who are able to communicate verbally and volunteer to participate. Exclusion criteria include diagnosed dementia, major psychiatric illness, severe sensory impairment preventing participation, or unwillingness to attend intervention sessions.
Intervention
Eight structured sessions are delivered to the intervention group:
- Orientation and baseline assessment
- Cognitive stimulation activities
- Emotional well-being and social interaction activities
- Physical activity and brain-health education
- Creative expression and art-based engagement
- Nutrition and brain-healthy dietary education
- Sleep education and relaxation techniques
- Reflection, feedback, and post-test assessment
The control group receives routine nursing home activities only.
Outcome Measures
Primary Outcome:
The Alzheimer's Disease Risk Index-Short Form (ANU-ADRI-SF), a self-report instrument assessing demographic, lifestyle, and medical factors associated with Alzheimer's disease risk. Scores are collected at baseline and at 4 weeks.
Secondary Outcomes:
Measures assessing cognitive activity participation and affect-related lifestyle factors, collected at baseline and 4 weeks.
Randomization and Allocation Concealment Participants are randomized using a computer-generated list stratified by institution. Allocation is concealed through sequentially numbered, opaque, sealed envelopes prepared by an independent researcher.
Blinding Due to the nature of the intervention, participants and facilitators cannot be blinded. Outcome assessors and data analysts remain blinded.
Ethics The study was approved by the Burdur Mehmet Akif Ersoy University Ethics Committee (GO 2025/1069). Written informed consent is obtained from all participants.
Data Collection and Timing Baseline and post-intervention assessments are administered individually by the researcher in a private room within the nursing homes.
Statistical Analysis Plan Descriptive statistics and statistical procedures appropriate to the data structure will be applied. Analyses will be conducted according to the predefined analysis plan.
- Conditions
- Cognitive Decline, Aging, Alzheimer Disease
- Being tested
- Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention
- Keywords
- Alzheimer's Disease Risk, Cognitive Health, Aging, Multidomain Lifestyle Intervention, Older Adults
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinde Zihin (Fit Mind) Multidomain Lifestyle InterventionBehavioural
Also called Fit Mind Program, Multidomain Lifestyle Intervention, Cognitive Health Promotion Program, Healthy Aging Behavioral Program
The Zinde Zihin (Fit Mind) program is a culturally adapted multidomain lifestyle intervention developed to enhance cognitive health, emotional well-being, and daily functioning in older adults. The program combines four evidence-based components-cognitive training, physical activity, nutritional education, and psychosocial stimulation-delivered in eight 60-75-minute sessions over four weeks. Activities included memory and problem-solving games, balance and stretching exercises, discussions on brain-healthy diets, and group-based art, music, and storytelling exercises to strengthen social engagement and mental resilience.
What distinguishes the Zinde Zihin program from other interventions is its cultural adaptation for Turkish older adults living in institutional settings. It integrates traditional Turkish music, storytelling, and collective art creation to increase emotional connection and sustainability. Sessions were held in small groups at nursing homes and facilitated by trained p
| Study group | Role | What they receive |
|---|---|---|
| Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention | Experimental | Participants in the intervention group received the eight-session Zinde Zihin (Fit Mind) multidomain lifestyle program, which combined cognitive training, moderate physical exercise, nutritional education, and psychosocial stimulation. Sessions were conducted twice weekly for four weeks in small group settings at nursing homes. Receives: Behavioral: Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention |
| Control Group - Routine Care | No intervention | Participants assigned to the control group continued their usual daily activities and standard care routines in the nursing home. They did not receive any structured sessions of the Zinde Zihin (Fit Mind) program or other organized lifestyle interventions during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ANU-ADRI-SF Total Risk Score
The Alzheimer's Disease Risk Index - Short Form (ANU-ADRI-SF; 45 items, 15 subscales) is a self-report instrument summing risk and protective factors; higher total scores indicate higher Alzheimer's disease risk. The primary endpoint is the change score (post - baseline). Negative values indicate risk reduction. Analyses will compare groups adjusting for cluster randomization (ICC).
Measured: Baseline (Week 0) to Post-intervention (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Model Description: Participants are individually randomized into two parallel groups (intervention and control). The intervention group receives the Zinde Zihin multidomain lifestyle program, delivered in eight structured sessions over four weeks. The program includes cognitive stimulation, physical activity, nutrition education, psychosocial engagement, and sleep/stress management activities. Sessions are group-based and facilitated by a trained researcher. The control group receives routine nursing home activities without any additional structured intervention. Baseline and post-intervention assessments are administered to all participants. The model aims to examine changes in Alzheimer's Disease Risk Index scores and related lifestyle factors under a parallel assignment design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Sezer Balci, Burdur Mehmet Akif Ersoy University
- Investigators
- Ayse Sezer Balci, PhD, Principal investigator, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244848
- Sponsor's protocol ID
- MAKU-ZINDEZIHIN-2025
- Other IDs
- Ethics Approval No: GO-2025/10
- Acronym
- ZZ-MIND
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared because the dataset contains sensitive personal health information collected from older adults living in nursing homes. Only aggregate (group-level) data will be published in scientific journals upon request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Zinde Zihin Multidomain Lifestyle Program on Alzheimer's Disease Risk: A Two-Center Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT07244848
- Acronym / sponsor ID
- ZZ-MIND / MAKU-ZINDEZIHIN-2025
- Conditions
- Cognitive Decline, Aging, Alzheimer Disease
- Keywords
- Alzheimer's Disease Risk, Cognitive Health, Aging, Multidomain Lifestyle Intervention, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 24 Nov 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.
This study aims to evaluate the feasibility and implementation of the Zinde Zihin ("Fit Mind") multidomain lifestyle program for older adults aged 65 years and older living in public nursing homes. The program includes cognitive activities, physical exercises, nutrition education, psychosocial engagement, sleep education, and stress-management components delivered in eight structured sessions over four weeks. The primary objective is to examine changes in Alzheimer's Disease Risk Index-Short Form (ANU-ADRI-SF) scores from baseline to post-intervention. Secondary objectives include assessing changes in cognitive activity engagement and affect-related lifestyle factors.
Detailed description
The Zinde Zihin ("Fit Mind") Program is a multidomain lifestyle intervention designed to promote healthy cognitive aging among older adults. The intervention integrates cognitive training, physical activity, nutritional education, psychosocial engagement, and sleep/stress management techniques within a group-based framework. The program is delivered in eight structured sessions over four weeks, with each session lasting approximately 60-75 minutes.
Study Rationale Lifestyle factors such as cognitive stimulation, physical activity, sleep, and social engagement play an important role in cognitive health. Multidomain interventions involving these components may support healthy aging. This study was developed to examine the feasibility of such an intervention in Turkish nursing home settings.
Study Design This is an individually randomized, controlled pretest-posttest study conducted in two public nursing homes. Randomization is performed at the individual level after eligibility screening. The protocol follows CONSORT guidelines for individually randomized trials.
Participants Eligible participants are adults aged 65 years or older with a Mini-Mental State Examination (MMSE) score ≥23 who are able to communicate verbally and volunteer to participate. Exclusion criteria include diagnosed dementia, major psychiatric illness, severe sensory impairment preventing participation, or unwillingness to attend intervention sessions.
Intervention
Eight structured sessions are delivered to the intervention group:
- Orientation and baseline assessment
- Cognitive stimulation activities
- Emotional well-being and social interaction activities
- Physical activity and brain-health education
- Creative expression and art-based engagement
- Nutrition and brain-healthy dietary education
- Sleep education and relaxation techniques
- Reflection, feedback, and post-test assessment
The control group receives routine nursing home activities only.
Outcome Measures
Primary Outcome:
The Alzheimer's Disease Risk Index-Short Form (ANU-ADRI-SF), a self-report instrument assessing demographic, lifestyle, and medical factors associated with Alzheimer's disease risk. Scores are collected at baseline and at 4 weeks.
Secondary Outcomes:
Measures assessing cognitive activity participation and affect-related lifestyle factors, collected at baseline and 4 weeks.
Randomization and Allocation Concealment Participants are randomized using a computer-generated list stratified by institution. Allocation is concealed through sequentially numbered, opaque, sealed envelopes prepared by an independent researcher.
Blinding Due to the nature of the intervention, participants and facilitators cannot be blinded. Outcome assessors and data analysts remain blinded.
Ethics The study was approved by the Burdur Mehmet Akif Ersoy University Ethics Committee (GO 2025/1069). Written informed consent is obtained from all participants.
Data Collection and Timing Baseline and post-intervention assessments are administered individually by the researcher in a private room within the nursing homes.
Statistical Analysis Plan Descriptive statistics and statistical procedures appropriate to the data structure will be applied. Analyses will be conducted according to the predefined analysis plan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Model Description: Participants are individually randomized into two parallel groups (intervention and control). The intervention group receives the Zinde Zihin multidomain lifestyle program, delivered in eight structured sessions over four weeks. The program includes cognitive stimulation, physical activity, nutrition education, psychosocial engagement, and sleep/stress management activities. Sessions are group-based and facilitated by a trained researcher. The control group receives routine nursing home activities without any additional structured intervention. Baseline and post-intervention assessments are administered to all participants. The model aims to examine changes in Alzheimer's Disease Risk Index scores and related lifestyle factors under a parallel assignment design.
| Arm | Type | Receives |
|---|---|---|
| Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention | Experimental | Behavioral: Zinde Zihin (Fit Mind) Multidomain Lifestyle InterventionParticipants in the intervention group received the eight-session Zinde Zihin (Fit Mind) multidomain lifestyle program, which combined cognitive training, moderate physical exercise, nutritional education, and psychosocial stimulation. Sessions were conducted twice weekly for four weeks in small group settings at nursing homes. |
| Control Group - Routine Care | No intervention | –Participants assigned to the control group continued their usual daily activities and standard care routines in the nursing home. They did not receive any structured sessions of the Zinde Zihin (Fit Mind) program or other organized lifestyle interventions during the study period. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 65 Years to 80 Years (Older Adult)
- All
- Yes
Key exclusion criteria (4 listed)
- Diagnosis of dementia or severe cognitive impairment.
- History of depression or major psychiatric disorder.
- Physical disability or medical condition prevents participation in exercise.
- Attendance in less than two-thirds of the planned intervention sessions.
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 |
|---|---|---|
| Zinde Zihin (Fit Mind) Multidomain Lifestyle InterventionAlso: Fit Mind Program, Multidomain Lifestyle Intervention, Cognitive Health Promotion Program, Healthy Aging Behavioral ProgramThe Zinde Zihin (Fit Mind) program is a culturally adapted multidomain lifestyle intervention developed to enhance cognitive health, emotional well-being, and daily functioning in older adults. The program combines four evidence-based components-cognitive training, physical activity, nutritional education, and psychosocial stimulation-delivered in eight 60-75-minute sessions over four weeks. Activities included memory and problem-solving games, balance and stretching exercises, discussions on brain-healthy diets, and group-based art, music, and storytelling exercises to strengthen social engagement and mental resilience. What distinguishes the Zinde Zihin program from other interventions is its cultural adaptation for Turkish older adults living in institutional settings. It integrates traditional Turkish music, storytelling, and collective art creation to increase emotional connection and sustainability. Sessions were held in small groups at nursing homes and facilitated by trained p | Behavioural | Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention |
Primary outcome
Change in ANU-ADRI-SF Total Risk Score
Time frame: Baseline (Week 0) to Post-intervention (Week 4)
The Alzheimer's Disease Risk Index - Short Form (ANU-ADRI-SF; 45 items, 15 subscales) is a self-report instrument summing risk and protective factors; higher total scores indicate higher Alzheimer's disease risk. The primary endpoint is the change score (post - baseline). Negative values indicate risk reduction. Analyses will compare groups adjusting for cluster randomization (ICC).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No. The individual participant data will not be shared because the dataset contains sensitive personal health information collected from older adults living in nursing homes. Only aggregate (group-level) data will be published in scientific journals upon request.
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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. This study is not recruiting at the moment.
Ayse Sezer Balci, PhD principal investigator
Burdur Mehmet Akif Ersoy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention in people with Cognitive Decline and Aging, run by Burdur Mehmet Akif Ersoy 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 6 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: finished, as of the sponsor's last update on 24 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ANU-ADRI-SF Total Risk Score (time frame: Baseline (Week 0) to Post-intervention (Week 4)). 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 24 Nov 2025.