- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07638046
Mindful Walking Neural Correlates of Executive Function in SC Older Adults at Risk of Dementias
2026년 6월 5일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
54
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Halle Prine, MS
- 전화번호: 8039997392
- 이메일: HPRINE@email.sc.edu
연구 장소
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South Carolina
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Columbia, South Carolina, 미국, 29201
- 모병
- University of South Carolina
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연락하다:
- Chih-Hsiang Yang
- 전화번호: 8037771025
- 이메일: cy11@mailbox.sc.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Mindful walking arm
Older adults will participate in 8 sessions of mindful walking over one month
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Implementing mindfulness skills during the walking movement
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활성 비교기: Walking-only arm
Older adults will participate in 8 sessions of walking over one month
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Implementing mindfulness skills during the walking movement
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hemodynamic activation signal
기간: Assessed at baseline, 4 weeks, 8 weeks
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Hemodynamic activation in the prefrontal and parietal regions as an indication of EF.
Neural activation will be measured using functional nearinfrared spectroscopy (fNIRS).
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Assessed at baseline, 4 weeks, 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neuropsychological function
기간: Assessed at baseline, 4 weeks, 8 weeks
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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.
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Assessed at baseline, 4 weeks, 8 weeks
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Executive function
기간: Assessed at Baseline, 4 weeks, 8 weeks
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NIH Toolbox Cognitive Battery will be used to measure fluid cognitive abilities
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Assessed at Baseline, 4 weeks, 8 weeks
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Trait Mindfulness Levels
기간: Assessed at Baseline, 4 weeks, 8 weeks
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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.
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Assessed at Baseline, 4 weeks, 8 weeks
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State Mindfulness Levels
기간: 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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall (in)activity levels
기간: Assessed at Baseline, 8 weeks
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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.
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Assessed at Baseline, 8 weeks
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Overall everyday cognition
기간: Assessed at Baseline, 8 weeks
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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.
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Assessed at Baseline, 8 weeks
|
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Overall health status
기간: 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.
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Assessed at Baseline, 8 weeks
|
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Height
기간: Assessed at Baseline, 8 weeks
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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.
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Assessed at Baseline, 8 weeks
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Weight
기간: Baseline, 8 weeks
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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.
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Baseline, 8 weeks
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Mobility
기간: Assessed at baseline, 8 weeks
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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.
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Assessed at baseline, 8 weeks
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Demographics
기간: Assessed at baseline
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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.
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Assessed at baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 22일
기본 완료 (추정된)
2027년 7월 1일
연구 완료 (추정된)
2027년 9월 1일
연구 등록 날짜
최초 제출
2026년 5월 16일
QC 기준을 충족하는 최초 제출
2026년 6월 5일
처음 게시됨 (실제)
2026년 6월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 5일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MODCR00000007
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Mindfulness-based walking에 대한 임상 시험
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