University of South Carolina
Columbia, South Carolina, 29201, United States
Location status: Recruiting
NCT Number: NCT07638046
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 2
Columbia, South Carolina, 29201, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. family history of ADRD (>= first-degree relative) ii. subjective experience of cognitive complaints iii. currently overweight or obese (BMI≥25)
Exclusion criteria
Implementing mindfulness skills during the walking movement
Older adults will participate in 8 sessions of walking over one month without being trained on mindfulness skills.
Time frame: 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).
Time frame: 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.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks
NIH Toolbox Cognitive Battery will be used to measure fluid cognitive abilities
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of South Carolina
Other
The Impact of Mindful Walking on Neural Correlates of Executive Function in SC Older Adults at Risk of Alzheimer's and Dementias
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