Mindful Walking Neural Correlates of Executive Function in SC Older Adults at Risk of Dementias
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of South Carolina
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 60 or older
Sedentary (sit ≥9hrs per day) and not meeting the US physical activity guidelines
Adequate hearing, visual and cognitive ability to complete study tasks and assessments
Able to walk without others' assistance
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-based walking
BehavioralImplementing mindfulness skills during the walking movement
Walking-only
BehavioralOlder adults will participate in 8 sessions of walking over one month without being trained on mindfulness skills.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Mindful walking armExperimental treatment 1 intervention
Group B: Walking-only armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Assessed at baseline, 4 weeks, 8 weeksSecondary outcomes
1
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.
Time frame
Assessed at baseline, 4 weeks, 8 weeks2
Executive function
NIH Toolbox Cognitive Battery will be used to measure fluid cognitive abilities
Time frame
Assessed at Baseline, 4 weeks, 8 weeks3
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.
Time frame
Assessed at Baseline, 4 weeks, 8 weeks4
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.
Time frame
Assessed at baseline, 4 weeks, 8 weeksOther outcomes
1
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.
Time frame
Assessed at Baseline, 8 weeks2
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.
Time frame
Assessed at Baseline, 8 weeks3
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.
Time frame
Assessed at Baseline, 8 weeks4
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.
Time frame
Assessed at Baseline, 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of South Carolina
Lead sponsor
USC Center for Clinical and Translational Research
Collaborator
Source ClinicalTrials.gov