Neurobehavioral Changes Following Spaceflight Stressors
NCT07293494
Alcohol Impairment, Behavior
View Trial DetailsNCT Number: NCT07728786
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Observational
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: Baseline (Data will be collected during a single cross-sectional assessment session for each participant).
Participants' physical activity levels over the past week will be measured using the Physical Activity Scale for the Elderly (PASE). The scale evaluates leisure, household, and occupational physical activities through structured questions. Higher total scores on the scale indicate a higher level of physical activity and engagement in daily life movements.
Contact information is provided by the study sponsor or research team.
Muğla Sıtkı Koçman University
Other
The Relationship of Outdoor and Indoor Exercises With Cognitive Functions in Older Individuals With Similar Physical Capacity: A Sample of Renewal Universities
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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