Recruiting
Phase 2

Mindful Walking

Sponsor:

University of South Carolina

Code:

NCT07638046

Conditions

Older Adults With Elevated Dementia Risk

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Mindfulness-based walking

Walking-only

Study Details

Brief summary:

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.

Conditions

Older Adults With Elevated Dementia Risk

Study ID

NCT07638046

Start date

Jun 26, 2026

Status verified date

Jul, 2026

Completion date

Nov 17, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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 Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mindful walking arm

Older adults will participate in 8 sessions of mindful walking over one month

active comparator: Walking-only arm

Older adults will participate in 8 sessions of walking over one month

Interventions

Mindfulness-based walking

Implementing mindfulness skills during the walking movement

Walking-only

Older adults will participate in 8 sessions of walking over one month without being trained on mindfulness skills.

Primary outcome measure

  • Hemodynamic activation signal [ Time Frame: Assessed at baseline, 4 weeks, 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29201

Contacts

More Information

Sponsor

University of South Carolina

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-07-10.