Zinde Zihin Program to Reduce Alzheimer's Disease Risk in Adults Aged 65 and Older (ZZ-MIND)

Burdur Mehmet Akif Ersoy University

Status: Completed

Conditions: Aging; Alzheimer Disease; Cognitive Decline

Treatments: Behavioral: Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07244848

MAKU-ZINDEZIHIN-2025

Ethics Approval No: GO-2025/10 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Ages Eligible for Study:

65 Years to 80 Years (Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention

Control Group - Routine Care

No Intervention group

Description:

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.