- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07728786
Outdoor vs. Indoor Exercises and Cognitive Functions in Older Adults
23. července 2026 aktualizováno: Meliha Güçlü Saz, Muğla Sıtkı Koçman University
The Relationship of Outdoor and Indoor Exercises With Cognitive Functions in Older Individuals With Similar Physical Capacity: A Sample of Renewal Universities
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.
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Odhadovaný)
100
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Meliha Güçlü Saz, MSc, PhD Student
- Telefonní číslo: +905374931504
- E-mail: melihaguclu@mu.edu.tr
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
The study population consists of older adults aged 60 and over who are actively enrolled as students at Köyceğiz Tazelenme University and Erzurum Tazelenme University in Türkiye.
This population represents a unique cohort of older individuals engaged in lifelong learning and structured active aging programs.
To investigate the specific role of the exercise environment on cognitive reserve, the sample will be drawn from this population using purposive sampling, selecting individuals who regularly participate in either structured outdoor or indoor physical activities.
The population is structurally characterized by functionally independent older adults who exhibit homogeneous physical baseline capacities-verified via objective clinical performance benchmarks-and are free from advanced neurological or debilitating physical conditions.
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Being under the age of 60.
- 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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Outdoor
This cohort consists of older adults aged 60 and over, enrolled in Tazelenme University, who regularly participate in physical exercises in outdoor environments.
Participants in this group maintain similar functional and physical capacities as verified by the 6-Minute Walk Test and the 30-Second Chair Stand Test, and they do not have any advanced neurological or severe physical impairments.
|
|
Indoor
This cohort consists of older adults aged 60 and over, enrolled in Tazelenme University, who regularly participate in physical exercises in indoor environments.
Participants in this group maintain similar functional and physical capacities as verified by the 6-Minute Walk Test and the 30-Second Chair Stand Test, and they do not have any advanced neurological or severe physical impairments.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall Cognitive Performance and Sub-domains via ACE-III
Časové okno: Baseline (Data will be collected during a single cross-sectional assessment session for each participant).
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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.
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Baseline (Data will be collected during a single cross-sectional assessment session for each participant).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Self-Reported Physical Activity Level via PASE
Časové okno: Baseline (Data will be collected during a single cross-sectional assessment session for each participant).
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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.
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Baseline (Data will be collected during a single cross-sectional assessment session for each participant).
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Albinet, C. T., Boucard, G., Bouquet, C. A., & Audiffren, M. (2012). Processing speed and executive functions in cognitive aging: How to disentangle their mutual relationship? Brain and Cognition, 79(1), 1-11. https://doi.org/10.1016/j.bandc.2012.02.001 Alcazar, J., Kamper, R. S., Aagaard, P., Haddock, B., Prescott, E., Ara, I., & Suetta, C. (2020). Relation between leg extension power and 30-s sit-to-stand muscle power in older adults: validation and translation to functional performance. Scientific Reports, 10(1). https://doi.org/10.1038/s41598-020-73395-4 Bautmans, I., Lambert, M., & Mets, T. (2004). The six-minute walk test in community dwelling elderly: Influence of health status. BMC Geriatrics, 4, 1-9. https://doi.org/10.1186/1471-2318-4-6 Biazus-Sehn, L. F., Schuch, F. B., Firth, J., & Stigger, F. de S. (2020). Effects of physical exercise on cognitive function of older adults with mild cognitive impairment: A systematic review and meta-analysis. In Archives of Gerontology and Geriatrics (Vol. 89). Elsevier Ireland Ltd. https://doi.org/10.1016/j.archger.2020.104048 Falck, R. S., Davis, J. C., Best, J. R., Crockett, R. A., & Liu-Ambrose, T. (2019, July 1). Impact of exercise training on physical and cognitive function among older adults: a systematic review and meta-analysis. In Neurobiology of Aging. Elsevier Inc. https://doi.org/10.1016/j.neurobiolaging.2019.03.007 Gallardo-Gómez, D., del Pozo-Cruz, J., Noetel, M., Álvarez-Barbosa, F., Alfonso-Rosa, R. M., & del Pozo Cruz, B. (2022). Optimal dose and type of exercise to improve cognitive function in older adults: A systematic review and bayesian model-based network meta-analysis of RCTs. In Ageing Research Reviews (Vol. 76). Elsevier Ireland Ltd. https://doi.org/10.1016/j.arr.2022.101591 Glisky, E. L., Woolverton, C. B., McVeigh, K. S., & Grilli, M. D. (2022). Episodic Memory and Executive Function Are Differentially Affected by Retests but Similarly Affected by Age in a Longitudinal Study of Normally-Aging
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. září 2026
Primární dokončení (Odhadovaný)
1. prosince 2026
Dokončení studie (Odhadovaný)
31. prosince 2026
Termíny zápisu do studia
První předloženo
16. června 2026
První předloženo, které splnilo kritéria kontroly kvality
23. července 2026
První zveřejněno (Aktuální)
27. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-ETÜ-0124
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Individual participant data (IPD) will not be shared publicly to maintain participant confidentiality and strictly protect personal privacy in accordance with the national Personal Data Protection Law (KVKK) and the institutional ethics committee guidelines.
Since the data collected includes comprehensive sociodemographic details and physical/cognitive functional health scores of vulnerable older adults, public sharing of raw individual datasets is restricted by the institutional ethical clearance.
However, aggregated statistical results and study outcomes will be fully accessible through peer-reviewed academic publications.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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