Effects of the Zinde Zihin Multidomain Lifestyle Program on Alzheimer's Disease Risk: A Two-Center Controlled Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in ANU-ADRI-SF Total Risk Score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the behavioral nature of the intervention, participants and facilitators were aware of group assignments. However, data collection and statistical analysis were conducted by independent researchers who were blinded to group allocation to minimize bias.
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages Eligible for Study:
- •65 Years to 80 Years (Older Adult)
- •Sexes Eligible for Study:
- •Accepts Healthy Volunteers:
排除标准
- •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.
研究组 & 干预措施
Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention
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.
干预措施: Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention (Behavioral)
Control Group - Routine Care
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.
结局指标
主要结局
Change in ANU-ADRI-SF Total Risk Score
时间窗: 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).
次要结局
未报告次要终点
研究者
Ayse Sezer Balci
Assistant Professor, PhD, RN - Department of Public Health Nursing, Burdur Mehmet Akif Ersoy University
Burdur Mehmet Akif Ersoy University