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Clinical Trials/NCT06085196
NCT06085196
Recruiting
Not Applicable

Evaluation of an Outdoor Mindful Walking Program for Sustaining Cognitive Function in Older African Americans at Risk for Dementia

University of South Carolina1 site in 1 country114 target enrollmentMay 16, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Function
Sponsor
University of South Carolina
Enrollment
114
Locations
1
Primary Endpoint
Cognitive Function as assessed by the Montreal Cognitive Assessment (MoCA)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to understand the beneficial role of mindful walking in sustaining cognitive health in African American older adults who have elevated risk of developing neuropsychological diseases. The main question it aims to answer is "Does a multi-session mindful walking intervention lead to promising signals of sustaining cognitive health in vulnerable AA older adults?" The researchers in this 2-arm randomized controlled trial will compare the mindful walking group with a delayed mindful walking to see if the intervention efficacy is observed at multiple follow-up period.

Detailed Description

African American (AA) older adults in the U.S. are disproportionally impacted by ADRD compared to other races and ethnicities. Mindful walking integrates two potentially protective factors of ADRD by elevating mindfulness and physical activity (i.e., walking), resulting in a synergistic behavioral strategy that is feasible and safe for older adults. However, the efficacy of using this intervention for cognitive health outcomes has not been tested using experimental designs. This study is a community-based, mindful walking randomized controlled trial to examine its efficacy on cognitive and other health outcomes in ADRD at-risk, AA older adults. This study will recruit 114 older adults (ages 60+ years) with elevated risk of developing ADRD from the Midlands region of South Carolina. Older adults were randomly assigned to participate in 24 sessions of mindful walking or a delayed mindful walking group (n=57 in each group). The study outcomes include various key brain health determinants, including cognitive function, quality of life, psychological well-being, physical activity, mindfulness, sleep, and overall health status. Participants in both groups follow identical measurement protocol of at baseline, 12 weeks, 18 weeks, and 24 weeks. The outcome measures are administered in the lab and in everyday settings. This study will generate preliminary evidence regarding the effects of mindful walking on sustaining cognition health. It will also inform future large-scale effectiveness trials to validate our study findings. If successful, this mindful walking program can be scaled up as a low-cost and viable lifestyle strategy to promote healthy cognitive aging in diverse older adult populations, including those at greatest risk.

Registry
clinicaltrials.gov
Start Date
May 16, 2023
End Date
September 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chih-Hsiang Yang

Assistant Professor

University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • African American ages 60 and above
  • Mild symptoms of cognitive decline or MCI
  • Physically inactive or insufficiently active (based on the 2018 US guidelines)
  • Adequate hearing and visual ability to complete study tasks and assessments
  • English proficiency
  • Medically stable with or without medication
  • Capable of providing informed consent
  • Willing to be randomized to one of the two groups

Exclusion Criteria

  • Clinical diagnosis of ADRD or other brain abnormalities (e.g., strokes, epilepsy, Parkinson's disease
  • Clinical diagnosis of psychiatric disorders (i.e., depression, post-traumatic stress disorder, bipolar disorder)
  • Unable to walk independently (i.e., need caregiver's assistance) 4) Plan to have surgery or relocate outside the area within the next 6 months
  • Currently participate in other studies involving physical activity, mindfulness, or cognitive training

Outcomes

Primary Outcomes

Cognitive Function as assessed by the Montreal Cognitive Assessment (MoCA)

Time Frame: Baseline, 12,18,24 weeks follow-up

MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, conceptual thinking, calculations, and orientation.

Everyday Cognition as assessed by the NIH Mobile Toolbox

Time Frame: Baseline, 18, 24 weeks follow-up (4 days each), Weeks 12 and 13 (14 days)

The NIH Mobile Toolbox is a smartphone-based, ultra-brief cognitive assessments to measure different domains of cognition using the smartphone screen.

Secondary Outcomes

  • Subjective Physical Activity Levels as assessed by the CHAMPS (Community Health Activities Model Program for Seniors) questionnaire(Baseline, 12,18,24 weeks follow-up)
  • Mobility as assessed by the 10-meter walk test(Baseline, 12,18,24 weeks follow-up)
  • Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, 12,18,24 weeks follow-up)
  • Perceived Stress as assessed by the Perceived Stress Scale (PSS-10)(Baseline, 12,18,24 weeks follow-up)
  • Perceived Quality of Life as assessed by the EuroQol 5 dimensions and 5 levels questionnaire(Baseline, 12,18,24 weeks follow-up)
  • Mindfulness Level as assessed by the Mindfulness Attention Awareness Scale and Five Facet Mindfulness Questionnaire(Baseline, 12,18,24 weeks follow-up)
  • Overall Health Status as assessed by the SF-36 self-report survey(Baseline, 12,18,24 weeks follow-up)
  • Depressive Symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, 12,18,24 weeks follow-up)
  • Device-based Physical Activity Levels as assessed by the activPAL Accelerometer(Weeks 12 and 13 (14 days))

Study Sites (1)

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