- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07728786
Outdoor vs. Indoor Exercises and Cognitive Functions in Older Adults
23. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Meliha Güçlü Saz, MSc, PhD Student
- Telefonnummer: +905374931504
- E-mail: melihaguclu@mu.edu.tr
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Cognitive Performance and Sub-domains via ACE-III
Tidsramme: 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.
|
Baseline (Data will be collected during a single cross-sectional assessment session for each participant).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-Reported Physical Activity Level via PASE
Tidsramme: 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.
|
Baseline (Data will be collected during a single cross-sectional assessment session for each participant).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
31. december 2026
Datoer for studieregistrering
Først indsendt
16. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juli 2026
Først opslået (Faktiske)
27. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-ETÜ-0124
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
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