Mindful Walking Neural Correlates of Executive Function in SC Older Adults at Risk of Dementias

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.

Study Overview

• Status: Recruiting
• Conditions: Older Adults With Elevated Dementia Risk
• Intervention / Treatment: Behavioral: Mindfulness-based walking

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Halle Prine, MS; Phone Number: 8039997392; Email: HPRINE@email.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Recruiting
      • University of South Carolina
      • Contact: Chih-Hsiang Yang; Phone Number: 8037771025; Email: cy11@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 60 or older
2. Sedentary (sit ≥9hrs per day) and not meeting the US physical activity guidelines

3. 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)

4. Adequate hearing, visual and cognitive ability to complete study tasks and assessments
5. Able to walk without others' assistance
6. 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:

1. Diagnosis of ADRD or other brain abnormalities (i.e., strokes, epilepsy, Parkinson's disease)
2. Diagnosis of mental disorders (i.e., depression)
3. Inability to complete surveys on mobile device or wear the activity monitor (i.e., due to arthritis, physical limitations, or other reasons)
4. Plan to move or have surgery in next 4 months
5. Currently participate in other study involving physical activity or cognitive training that may interfere with the study outcomes
6. Unable to provide consent due to disabilities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful walking arm; Older adults will participate in 8 sessions of mindful walking over one month	Behavioral: Mindfulness-based walking; Implementing mindfulness skills during the walking movement
Active Comparator: Walking-only arm; Older adults will participate in 8 sessions of walking over one month	Behavioral: Mindfulness-based walking; Implementing mindfulness skills during the walking movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic activation signal	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychological function	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	NIH Toolbox Cognitive Battery will be used to measure fluid cognitive abilities	Assessed at Baseline, 4 weeks, 8 weeks
Trait Mindfulness Levels	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall (in)activity levels	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	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	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	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	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
Mobility	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	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

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: USC The Center for Clinical & Translational Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 16, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MODCR00000007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No