Clinical trial NCT06085196: Mindful Walking Program for Older African Americans
Official title: Evaluation of an Outdoor Mindful Walking Program for Sustaining Cognitive Function in Older African Americans at Risk for Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Function
Aging Well
Behavior, Health
Keywords: Walking
Mindfulness
Lifestyle activity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2023-10-16
Enrollment: 114
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Clinical diagnosis of ADRD or other brain abnormalities (e.g., strokes, epilepsy, Parkinson's disease
2. Clinical diagnosis of psychiatric disorders (i.e., depression, post-traumatic stress disorder, bipolar disorder)
3. 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

5) Currently participate in other studies involving physical activity, mindfulness, or cognitive training

Primary outcomes:
measure: Cognitive Function as assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 12,18,24 weeks follow-up
measure: Everyday Cognition as assessed by the NIH Mobile Toolbox
timeFrame: Baseline, 18, 24 weeks follow-up (4 days each), Weeks 12 and 13 (14 days)
Secondary outcomes:
measure: Perceived Quality of Life as assessed by the EuroQol 5 dimensions and 5 levels questionnaire
timeFrame: Baseline, 12,18,24 weeks follow-up
measure: Subjective Physical Activity Levels as assessed by the CHAMPS (Community Health Activities Model Program for Seniors) questionnaire
timeFrame: Baseline, 12,18,24 weeks follow-up
measure: Device-based Physical Activity Levels as assessed by the activPAL Accelerometer
timeFrame: Weeks 12 and 13 (14 days)
measure: Mindfulness Level as assessed by the Mindfulness Attention Awareness Scale and Five Facet Mindfulness Questionnaire
timeFrame: Baseline, 12,18,24 weeks follow-up
measure: Overall Health Status as assessed by the SF-36 self-report survey
timeFrame: Baseline, 12,18,24 weeks follow-up
measure: Mobility as assessed by the 10-meter walk test
timeFrame: Baseline, 12,18,24 weeks follow-up
measure: Perceived Stress as assessed by the Perceived Stress Scale (PSS-10)
timeFrame: Baseline, 12,18,24 weeks follow-up
measure: Depressive Symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, 12,18,24 weeks follow-up
measure: Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 12,18,24 weeks follow-up
Other outcomes:
measure: Height as measured from the top of the person's head to the heel using digital stadiometer
timeFrame: Baseline
measure: Weight as measured using a digital floor scale
timeFrame: Baseline
measure: Body Mass Index (BMI) as calculated by the height and weight measures
timeFrame: Baseline
measure: Waist Circumference as measured using a tape measure at the uppermost lateral border of the ilium
timeFrame: Baseline
measure: Systolic and diastolic blood pressures as measured using the automatic arm blood pressure monitor
timeFrame: Baseline
measure: Health Literacy as assessed by a validated survey item
timeFrame: Baseline
measure: Grip Strength as measured using the digital dynamometer
timeFrame: Baseline
measure: Daily Functioning as assessed by the Brody Instrumental Activities of Daily Living Scale (IADL)
timeFrame: Baseline
measure: Social Support as assess by the Perceived Social Support Scale (PSSS)
timeFrame: Baseline
measure: Medication Use as assessed using the general health needs survey
timeFrame: Baseline
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Chih-Hsiang "Jason" Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: