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临床试验/NCT07639203
NCT07639203招募中不适用

PotenziaMente: A Digital Executive Function Training Intervention for Healthy Aging in the Elderly Population

Università degli Studi di Trento1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Frontal Assessment Battery (Apollonio et al., 2005)

研究概览

简要总结

The study, entitled "PotenziaMente: Cognitive Training in Aging," is a clinical trial designed to evaluate the effectiveness of an individualized tablet-based cognitive training program targeting executive functions (e.g., planning, cognitive flexibility, and problem solving) in healthy older adults. Executive functions are higher-order cognitive processes that support adaptive functioning in daily life and influence other cognitive domains, such as memory. The primary aim of the study is to enhance cognitive performance, specifically executive functioning, in neurologically healthy adults aged 65 to 75 years. A secondary aim is to compare the effects of two different delivery modalities of the same cognitive training program: home-based self-administration via tablet versus supervised tablet-based training in the presence of a trained researcher. Participants will undergo cognitive assessments at baseline (pre-training), immediately after the intervention (post-training), and at a 3-month follow-up.

This is a randomized parallel-group interventional clinical trial without masking. Participants are randomly assigned to one of two groups: a home-based cognitive training condition, in which they perform an individualized tablet-based cognitive training program targeting executive functions independently at home via a tablet application without direct supervision, or a supervised cognitive training condition, in which they perform the same individualized tablet-based cognitive training under the supervision of a trained researcher in a controlled environment. The intervention consists of two sessions per week, 1 hour per session, for 4 consecutive weeks, delivered via tablet-based exercises. The study uses a parallel assignment model with a prospective design and a primary purpose of treatment (cognitive enhancement and prevention of cognitive decline).

The primary outcome is the change in executive functioning from baseline to post-intervention, assessed using standardized neuropsychological tests. Secondary outcomes include between-group differences (home-based vs. supervised) in executive functioning, changes in global cognitive functioning from baseline to post-intervention, and maintenance of cognitive effects at the 3-month follow-up.

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
None

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cognitively healthy adults aged 65 to 75 years. Montreal Cognitive Assessment (MoCA) equivalent score ≥ 1, according to Italian normative values.

排除标准

  • History of current or previous neurological or neuropsychiatric disorders.

研究组 & 干预措施

Supervised In-Person Cognitive Training

Active Comparator

A group of participants randomly assigned to an in-person supervised tablet-based cognitive training intervention consisting of individualized training sessions aimed at improving cognitive performance.

干预措施: Supervised In-Person Cognitive Training (Behavioral)

Remote Cognitive Training

Experimental

A group of participants randomly assigned to a remote tablet-based cognitive training intervention through individualized training sessions aimed at improving cognitive performance.

干预措施: Remote Cognitive Training (Behavioral)

结局指标

主要结局

Frontal Assessment Battery (Apollonio et al., 2005)

时间窗: 0-4 months

Minimum value: 0; Maximum value: 18; Higher scores indicate better executive functioning.

次要结局

未报告次要终点

研究者

发起方
Università degli Studi di Trento
申办方类型
Other
责任方
Principal Investigator
主要研究者

Costanza Papagno

Study Director

Università degli Studi di Trento

研究点 (1)

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