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临床试验/NCT07728786
NCT07728786尚未招募不适用

The Relationship of Outdoor and Indoor Exercises With Cognitive Functions in Older Individuals With Similar Physical Capacity: A Sample of Renewal Universities

Muğla Sıtkı Koçman University0 个研究点目标入组 100 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Overall Cognitive Performance and Sub-domains via ACE-III

研究概览

简要总结

This observational, cross-sectional study aims to comparatively investigate the effects of outdoor versus indoor exercise environments on overall cognitive performance and its specific sub-domains (attention, memory, and executive functions) in older adults with similar physical capacities. Utilizing a 2 (Exercise Environment: Outdoor vs. Indoor) x 2 (Center: Köyceğiz vs. Erzurum Tazelenme University) factorial design, a sample of 100-120 participants aged 60 and over will be recruited via purposive sampling. To ensure sample homogeneity regarding functional capacity, participants will undergo pre-screening with the 6-Minute Walk Test (6MWT) and the 30-Second Chair Stand Test, while individuals with advanced neurological disorders or severe physical impairments will be excluded. Data will be collected through a Sociodemographic Information Form, the Physical Activity Scale for the Elderly (PASE) to monitor baseline activity parameters, and the Addenbrooke's Cognitive Examination (ACE-III) Turkish Version A to assess cognitive outcomes. Ultimately, this study aims to elucidate the potential predictive role of the exercise environment on cognitive health in late life and explore whether the cognitive benefits of physical activity vary interactively across different geographic centers.

详细描述

This observational, cross-sectional study is designed with a comprehensive quality assurance and operational framework to rigorously investigate the impact of exercise environments on cognitive health in older adults. To ensure data integrity and minimize transcription errors, a multi-stage quality control protocol will be enforced, including double-data entry by two independent investigators and automated database range checks for score boundaries (e.g., restricting the total score of Addenbrooke's Cognitive Examination [ACE-III] between 0 and 100, and validating the age threshold as ≥ 60). Source data verification will be conducted by cross-referencing self-reported chronic conditions and pharmacological backgrounds with institutional health registries where applicable. Operationally, the study follows a strict six-stage Standard Operating Procedure (SOP). Potential participants from Köyceğiz and Erzurum Tazelenme Universities will first undergo a face-to-face pre-screening via a structured Participant Eligibility Form to confirm inclusion criteria, which mandate being aged 60 or older, participating in regular physical exercise, and possessing sufficient sensory and cognitive capacity to complete behavioral testing, while excluding individuals with advanced neurological disorders such as dementia.Following informed consent, participants' functional baseline homogeneity will be verified through validated physical performance metrics, specifically the 6-Minute Walk Test (6MWT) for cardiovascular endurance and the 30-Second Chair Stand Test for lower extremity muscle strength. Based on their primary exercise habits, participants will be classified into the primary independent variables: outdoor or indoor exercise environments. Subsequently, cognitive outcomes across domains of attention, memory, verbal fluency, language, and visuospatial skills will be assessed individually in a controlled, distraction-free environment using the ACE-III Turkish Version A, while past-week physical activity levels will be quantified using the Physical Activity Scale for the Elderly (PASE). Missing data will be managed strictly; variables with less than 15% missing items will be handled via sub-domain mean imputation, whereas cases exceeding this threshold or missing primary cognitive components will be excluded via listwise deletion. Statistical analyses will be executed using IBM SPSS Statistics, utilizing independent samples t-tests or non-parametric Mann-Whitney U tests depending on normality distributions evaluated via Kolmogorov-Smirnov and Shapiro-Wilk criteria. Ultimately, Pearson or Spearman correlation coefficients will assess the relationship between exercise parameters and cognitive scores, and multiple linear regression or analysis of covariance (ANCOVA) will be deployed to isolate the predictive value of the exercise environment on cognitive performance while strictly controlling for confounding covariates such as age, education, baseline physical activity (PASE), and functional capacities (6MWT and chair stand scores), with significance established at p < 0.05.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be aged 60 years or older.
  • Must be currently enrolled as a student at Köyceğiz Tazelenme University or Erzurum Tazelenme University.
  • Must participate regularly in either structured outdoor or indoor physical exercises.
  • Must possess sufficient sensory, visual, hearing, and cognitive capacity to comprehend and complete the behavioral and cognitive tests.
  • Must demonstrate similar and homogenous functional physical capacity as verified by the pre-screening benchmarks of the 6-Minute Walk Test and the 30-Second Chair Stand Test.
  • Must provide written informed consent voluntarily.

排除标准

  • Being under the age of
  • Having a clinical diagnosis of an advanced neurological disorder, including dementia or severe cognitive impairment.
  • Having severe acute or chronic physical disabilities, musculoskeletal injuries, or medical conditions that medically prevent or restrict safe exercise participation.
  • Having severe uncorrected sensory (visual or hearing) deficits or cognitive impairments that prevent the comprehension of test instructions or completion of the assessments.
  • Refusing to provide written informed consent or wishing to withdraw from the evaluation process.

结局指标

主要结局

Overall Cognitive Performance and Sub-domains via ACE-III

时间窗: Baseline (Data will be collected during a single cross-sectional assessment session for each participant).

Cognitive functions will be assessed using the Addenbrooke's Cognitive Examination-III (ACE-III) Turkish Version A. The test comprehensively evaluates five cognitive domains: attention, memory, verbal fluency, language, and visuospatial skills. Total scores range from 0 to 100, and sub-domain scores range as follows: Attention (0-18), Memory (0-26), Verbal Fluency (0-14), Language (0-26), and Visuospatial (0-16). Higher total and sub-domain scores indicate better cognitive performance and higher cognitive reserve.

次要结局

  • Self-Reported Physical Activity Level via PASE(Baseline (Data will be collected during a single cross-sectional assessment session for each participant).)

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meliha Güçlü Saz

Research Assistant

Muğla Sıtkı Koçman University

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