- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07638046
Mindful Walking Neural Correlates of Executive Function in SC Older Adults at Risk of Dementias
5 czerwca 2026 zaktualizowane przez: Chih-Hsiang Yang, University of South Carolina
The Impact of Mindful Walking on Neural Correlates of Executive Function in SC Older Adults at Risk of Alzheimer's and Dementias
Mindful walking is a promising and practical strategy because it combines two activities known to support healthy aging: walking and mindfulness.
Unlike many structured exercise programs, mindful walking is low intensity, accessible, and easier to sustain in daily life.
It may be especially useful for older adults at elevated risk for ADRD.
However, most existing mindful walking studies have focused on mental health outcomes, such as stress reduction, rather than cognitive health.
Little is known about whether mindful walking can support cognition or how it may influence brain function.
To address this gap and strengthen a future R01 resubmission, the investigators propose a two-arm randomized controlled pilot trial using functional near-infrared spectroscopy (fNIRS), a safe, non-invasive brain imaging method.
fNIRS measures brain activity through sensors placed on the scalp and is well-suited for repeated assessments in older adults because it is quiet, portable, painless, and cost-effective.
The investigators will recruit racially and ethnically diverse middle-aged and older adults from the Midlands of South Carolina who are at elevated risk for ADRD.
Participants will be randomly assigned to one of two groups: mindful walking or walking-only control.
Both groups will complete 8 staff-supervised individual sessions over 4 weeks.
The mindful walking group will learn and practice simple mindfulness skills while walking in multiple settings, including lab-based, indoor, and outdoor environments, to support real-world use.
Findings from this pilot study will provide important evidence on whether mindful walking can support brain and cognitive health in adults at elevated risk for ADRD.
The results will also help establish a practical, scalable, and sustainable prevention strategy for underserved aging populations in South Carolina.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Szczegółowy opis
The number of older adults living with Alzheimer's disease and related dementias (ADRD) is escalating around the world, yet no effective treatment is currently available.
Non-pharmacological early preventive strategies are urgently needed to mitigate the social and economic burden of ADRD and to sustain quality of life in the aging population, including the seniors living in South Carolina (SC).
Mindful walking represents a promising prevention approach to sustain cognition, as it simultaneously practices mindfulness skills during physical activity (walking).
However, existing mindful walking programs primarily focused on mental health outcomes (e.g., stress reduction) and overlooked the potential efficacy on cognition.
This lower-intensity lifestyle physical activity may be a more viable and inclusive prevention strategy with greater scalability and long-term sustainability to serve ADRD at-risk aging populations.
Our preliminary work in African American older adults around the Midlands of SC has established preliminary signals that mindful walking is feasible, acceptable, and it may sustain proximal cognitive function.
However, the literature to date has not tested the neural-level correlates underlying mindful walking to infer the potential mechanism related to executive function enhancement.
This is also a gap raised by a reviewer from our scored R01 in 2023 (not funded, 40th percentile).
To address this knowledge gap and strengthen our R01 resubmission, our team proposes to conduct a two-arm randomized controlled pilot trial to determine the neural-level underpinning of mindful walking using the Functional near-infrared spectroscopy (fNIRS).
fNIRS offers a non-invasive neuroimaging tool that uses source-detector channels placed on the scalp to measure event-evoked neural activities across the lifespan (e.g., engaged executive function while practicing mindfulness skills).
fNIRS is a device that is well-suited for within-subjects repeated data collection in older adults because it is noiseless and compact, painless, and cost-effective, making it suitable to apply in a behavioral trial that requires multiple assessments.
This randomized controlled trial will recruit race and ethnically diverse middle-aged and older adults who have elevated risk(s) for ADRD from the Midlands of SC.
Participants will be randomly assigned to participate in 8 sessions of individual mindful walking or a walking-only control group supervised by the staff across 4 weeks.
The mindful walking group will be instructed to practice simple but fundamental mindfulness skills in multiple settings to facilitate real-world skill translation (in lab, indoor, outdoor).
This study will administer lab-based measures of cognitive assessments, including the fNIRS, MoCA, and NIH Toolbox Cognition Battery, to examine group differences in neural activations measured using fNIRS (Aim 1) and the concordance between executive function measured using fNIRS, MoCA, and NIH Toolbox (Aim 2).
Findings from this study have the potential to provide a viable and achievable behavioral strategy that can be engaged in daily life to address cognitive health and reduce ADRD risk among underserved older populations in the Midlands of SC.
It will also well-position our team to submit R01s in the following years to support this timely and critical research.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
54
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Halle Prine, MS
- Numer telefonu: 8039997392
- E-mail: HPRINE@email.sc.edu
Lokalizacje studiów
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South Carolina
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Columbia, South Carolina, Stany Zjednoczone, 29201
- Rekrutacyjny
- University of South Carolina
-
Kontakt:
- Chih-Hsiang Yang
- Numer telefonu: 8037771025
- E-mail: cy11@mailbox.sc.edu
-
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- Age 60 or older
- Sedentary (sit ≥9hrs per day) and not meeting the US physical activity guidelines
Have at least one of the following ADRD risk factors:
i. family history of ADRD (>= first-degree relative) ii. subjective experience of cognitive complaints iii. currently overweight or obese (BMI≥25)
- Adequate hearing, visual and cognitive ability to complete study tasks and assessments
- Able to walk without others' assistance
- Medically stable with or without medication (do not expect to have major health status changes or a surgery in the next 4 months)
Exclusion Criteria:
- Diagnosis of ADRD or other brain abnormalities (i.e., strokes, epilepsy, Parkinson's disease)
- Diagnosis of mental disorders (i.e., depression)
- Inability to complete surveys on mobile device or wear the activity monitor (i.e., due to arthritis, physical limitations, or other reasons)
- Plan to move or have surgery in next 4 months
- Currently participate in other study involving physical activity or cognitive training that may interfere with the study outcomes
- Unable to provide consent due to disabilities
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Mindful walking arm
Older adults will participate in 8 sessions of mindful walking over one month
|
Implementing mindfulness skills during the walking movement
|
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Aktywny komparator: Walking-only arm
Older adults will participate in 8 sessions of walking over one month
|
Implementing mindfulness skills during the walking movement
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Hemodynamic activation signal
Ramy czasowe: Assessed at baseline, 4 weeks, 8 weeks
|
Hemodynamic activation in the prefrontal and parietal regions as an indication of EF.
Neural activation will be measured using functional nearinfrared spectroscopy (fNIRS).
|
Assessed at baseline, 4 weeks, 8 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Neuropsychological function
Ramy czasowe: Assessed at baseline, 4 weeks, 8 weeks
|
Montreal Cognitive Assessment (MoCA) is sensitive to measure normal cognitive aging from those with mild cognitive decline.
MoCA scores range from 1-30 to detect cognitive impairment.
Higher scores indicate better cognitive function.
|
Assessed at baseline, 4 weeks, 8 weeks
|
|
Executive function
Ramy czasowe: Assessed at Baseline, 4 weeks, 8 weeks
|
NIH Toolbox Cognitive Battery will be used to measure fluid cognitive abilities
|
Assessed at Baseline, 4 weeks, 8 weeks
|
|
Trait Mindfulness Levels
Ramy czasowe: Assessed at Baseline, 4 weeks, 8 weeks
|
Using the validated five-facet mindfulness scale (FFMQ) to measure trait mindfulness.
FFMQ scores range from 39-195.
Higher scores indicate higher trait mindfulness levels.
|
Assessed at Baseline, 4 weeks, 8 weeks
|
|
State Mindfulness Levels
Ramy czasowe: Assessed at baseline, 4 weeks, 8 weeks
|
Using the validated state mindfulness scale (SMS) to measure state mindfulness.
SMS scores range from 21-105.
Higher scores indicate higher state mindfulness levels.
|
Assessed at baseline, 4 weeks, 8 weeks
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall (in)activity levels
Ramy czasowe: Assessed at Baseline, 8 weeks
|
Using the physical activity and sedentary behavior questionnaire (PASB-Q) to assess older adults' overall (in)activity levels.
The questionnaire asks participants about their typical weekly physical activity minutes and daily sitting hours.
|
Assessed at Baseline, 8 weeks
|
|
Overall everyday cognition
Ramy czasowe: Assessed at Baseline, 8 weeks
|
Using everyday cognition scale (ECog) to assess memory, planning, organization, and divided attention in daily contexts.
Each item ranges from 1-4 points.
The overall score is calculated as an average of all completed items, resulting in a score range of 1 to 4. The higher scores represent worse everyday cognition.
|
Assessed at Baseline, 8 weeks
|
|
Overall health status
Ramy czasowe: Assessed at Baseline, 8 weeks
|
Using SF-36 questionnaire to assess overall health status.
For all domain scales and component scores, the scoring range is 0 to 100, with higher scores representing a more favorable or higher level of health.
|
Assessed at Baseline, 8 weeks
|
|
Height
Ramy czasowe: Assessed at Baseline, 8 weeks
|
Applying the NIH PhenX Toolkit protocol.
Participants' standing height is measured from the top of the participant's head to their heels.
The measure will be conducted in duplicates and will be recorded to the nearest 0.1 cm.
This measure will be combined with the weight measure to measure participants' BMI in kg/ m^2.
|
Assessed at Baseline, 8 weeks
|
|
Weight
Ramy czasowe: Baseline, 8 weeks
|
Applying the NIH PhenX Toolkit protocol.
Participants' weight will be measured using a digital floor scale.
Their weight will be measured in duplicates and will be recorded to the nearest 0.1 kg.
This measure will be combined with the height measure to calculate participants' BMI in kg/ m^2.
|
Baseline, 8 weeks
|
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Mobility
Ramy czasowe: Assessed at baseline, 8 weeks
|
Applying the NIH PhenX Toolkit 10-meter walk protocol to assess mobility.
The test outcome is typically expressed as gait speed in meters per second (m/s).
The lower values indicate a higher risk of adverse health events.
|
Assessed at baseline, 8 weeks
|
|
Demographics
Ramy czasowe: Assessed at baseline
|
Collected basic demographics via an online survey.
All items are assessed using multiple-choice or multiple-selection questions of different types of participants' demographic status.
The response options are thus categorical but not a scale.
|
Assessed at baseline
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Yang CH, Maher JP, Conroy DE. Acceptability of mobile health interventions to reduce inactivity-related health risk in central Pennsylvania adults. Prev Med Rep. 2015 Aug 13;2:669-72. doi: 10.1016/j.pmedr.2015.08.009. eCollection 2015.
- Carpenter C, Yang CH, West D. A Comparison of Sedentary Behavior as Measured by the Fitbit and ActivPAL in College Students. Int J Environ Res Public Health. 2021 Apr 8;18(8):3914. doi: 10.3390/ijerph18083914.
- Yang CH, Huh J, Mason TB, Belcher BR, Kanning M, Dunton GF. Mother-child dyadic influences of affect on everyday movement behaviors: evidence from an ecological momentary assessment study. Int J Behav Nutr Phys Act. 2020 May 11;17(1):56. doi: 10.1186/s12966-020-00951-6.
- Lopez NV, Yang CH, Belcher BR, Margolin G, Dunton GF. Within-Subject Associations of Maternal Physical Activity Parenting Practices on Children's Objectively Measured Moderate-to-Vigorous Physical Activity. J Pediatr Psychol. 2019 Apr 1;44(3):300-310. doi: 10.1093/jpepsy/jsy100.
- Yang CH, Hakun JG, Roque N, Sliwinski MJ, Conroy DE. Mindful walking and cognition in older adults: A proof of concept study using in-lab and ambulatory cognitive measures. Prev Med Rep. 2021 Jul 14;23:101490. doi: 10.1016/j.pmedr.2021.101490. eCollection 2021 Sep.
- Yang CH, Conroy DE. Feasibility of an Outdoor Mindful Walking Program for Reducing Negative Affect in Older Adults. J Aging Phys Act. 2018 Nov 7:1-10. doi: 10.1123/japa.2017-0390. Online ahead of print.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
22 maja 2026
Zakończenie podstawowe (Szacowany)
1 lipca 2027
Ukończenie studiów (Szacowany)
1 września 2027
Daty rejestracji na studia
Pierwszy przesłany
16 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
10 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
10 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
5 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- MODCR00000007
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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