Cognitive FunctionNCT06085196
Mindful Walking Program for Older African Americans
A study testing Mindful walking activity in people with Cognitive Function and Aging Well, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Aging Well, Behavior, Health
- What is being tested?
- Mindful walking activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 5) Currently participate in other studies involving physical activity, mindfulness, or cognitive training
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Evaluation of an Outdoor Mindful Walking Program for Sustaining Cognitive Function in Older African Americans at Risk for Dementia
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.
Read the 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.
- Conditions
- Cognitive Function, Aging Well, Behavior, Health
- Being tested
- Mindful walking activity
- Keywords
- Walking, Mindfulness, Lifestyle activity
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful walking activityBehavioural
Participate in 24 sessions of outdoor mindful walking on a local walking trail over three months
| Study group | Role | What they receive |
|---|---|---|
| Mindful walking | Experimental | Complete a 24-session outdoor mindful walking intervention over 3 months Receives: Behavioral: Mindful walking activity |
| Delayed mindful walking group | Other | Option to complete a delayed 24-session mindful walking Receives: Behavioral: Mindful walking activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function as assessed by the Montreal Cognitive Assessment (MoCA)
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.
Measured: Baseline, 12,18,24 weeks follow-up
Everyday Cognition as assessed by the NIH Mobile Toolbox
The NIH Mobile Toolbox is a smartphone-based, ultra-brief cognitive assessments to measure different domains of cognition using the smartphone screen.
Measured: Baseline, 18, 24 weeks follow-up (4 days each), Weeks 12 and 13 (14 days)
Secondary outcomes (9)
Perceived Quality of Life as assessed by the EuroQol 5 dimensions and 5 levels questionnaire
The EuroQol 5 dimensions and 5 levels survey (EQ-5D-5L) is a self-assessed, health related, quality of life questionnaire. The questionnaire measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, ranging from 11111 (best) to 55555 (worst).
Measured: Baseline, 12,18,24 weeks follow-up
Subjective Physical Activity Levels as assessed by the CHAMPS (Community Health Activities Model Program for Seniors) questionnaire
The CHAMPS self-report questionnaire assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults
Measured: Baseline, 12,18,24 weeks follow-up
Device-based Physical Activity Levels as assessed by the activPAL Accelerometer
The activPAL is a small, slim activity monitor that uses an accelerometer to measure limb position and activity. It's worn on the thigh and uses algorithms to determine body posture, including moving, standing, and sitting.
Measured: Weeks 12 and 13 (14 days)
Mindfulness Level as assessed by the Mindfulness Attention Awareness Scale and Five Facet Mindfulness Questionnaire
Use Mindfulness Attention Awareness Scale (MAAS) is a 15-item self-report survey that measures mindfulness in general and in specific day-to-day circumstances. Each MAAS scores can range from 1 to 6. Higher scores indicate greater mindfulness; The Five Facet Mindfulness Questionnaire (FFMQ) has 39 self-reported items. It measures five mindfulness facets, including Observing, Describing, Acting with awareness, Non-judgmental, and Non-reactive. The items are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true).
Measured: Baseline, 12,18,24 weeks follow-up
Overall Health Status as assessed by the SF-36 self-report survey
The SF-36 is a 36-item survey that measures eight domains of health status. The survey is designed to capture adult patients' perceptions of their own health and well-being. The score range is 0 to 100. Higher scores indicate better health status.
Measured: Baseline, 12,18,24 weeks follow-up
Mobility as assessed by the 10-meter walk test
The 10-meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Measured: Baseline, 12,18,24 weeks follow-up
Perceived Stress as assessed by the Perceived Stress Scale (PSS-10)
The Perceived Stress Scale (PSS-10) is a 10-item questionnaire that measures psychological stress. The PSS-10 asks respondents to rate statements about their feelings and thoughts. Each question is scored from 0 (never) to 5 (very often) with a total possible score range of 0 to 40.
Measured: Baseline, 12,18,24 weeks follow-up
Depressive Symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item questionnaire that measures the severity of depressive symptoms in the general population. The CES-D has a possible range of scores from zero to 60. Higher scores indicate the presence of more symptomatology.
Measured: Baseline, 12,18,24 weeks follow-up
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire that assesses sleep quality and quantity. It has seven components, each rated from 0 (no difficulty) to 3 (severe difficulty). It has a global score range of 0 to 21. Higher scores indicate worse sleep quality.
Measured: Baseline, 12,18,24 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start16 May 2023
- Primary completion15 Jun 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Chih-Hsiang Yang, University of South Carolina
- Investigators
- Chih-Hsiang "Jason" Yang, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085196
- Sponsor's protocol ID
- Pro00123487
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang CH, Lee J, Wilcox S, Rudisill AC, Friedman DB, Hakun JG, Neils-Strunjas J, Wei J, Miller MC, Byers MD. Implementation and evaluation of a community-based mindful walking randomized controlled trial to sustain cognitive health in older African Americans at risk for dementia. BMC Geriatr. 2024 Jul 4;24(1):579. doi: 10.1186/s12877-024-05090-2.
PubMed 38965464
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Outdoor Mindful Walking Program for Sustaining Cognitive Function in Older African Americans at Risk for Dementia
- ClinicalTrials.gov ID
- NCT06085196
- Acronym / sponsor ID
- Pro00123487
- Conditions
- Cognitive Function, Aging Well, Behavior, Health
- Keywords
- Walking, Mindfulness, Lifestyle activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 16 May 2023 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful walking | Experimental | Behavioral: Mindful walking activityComplete a 24-session outdoor mindful walking intervention over 3 months |
| Delayed mindful walking group | Other | Behavioral: Mindful walking activityOption to complete a delayed 24-session mindful walking |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- 5) Currently participate in other studies involving physical activity, mindfulness, or cognitive training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful walking activityParticipate in 24 sessions of outdoor mindful walking on a local walking trail over three months | Behavioural | Delayed mindful walking group, Mindful walking |
Primary outcome
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.
9 secondary outcomes
Perceived Quality of Life as assessed by the EuroQol 5 dimensions and 5 levels questionnaire
Time frame: Baseline, 12,18,24 weeks follow-up
Subjective Physical Activity Levels as assessed by the CHAMPS (Community Health Activities Model Program for Seniors) questionnaire
Time frame: Baseline, 12,18,24 weeks follow-up
Device-based Physical Activity Levels as assessed by the activPAL Accelerometer
Time frame: Weeks 12 and 13 (14 days)
Mindfulness Level as assessed by the Mindfulness Attention Awareness Scale and Five Facet Mindfulness Questionnaire
Time frame: Baseline, 12,18,24 weeks follow-up
Overall Health Status as assessed by the SF-36 self-report survey
Time frame: Baseline, 12,18,24 weeks follow-up
Mobility as assessed by the 10-meter walk test
Time frame: Baseline, 12,18,24 weeks follow-up
Perceived Stress as assessed by the Perceived Stress Scale (PSS-10)
Time frame: Baseline, 12,18,24 weeks follow-up
Depressive Symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, 12,18,24 weeks follow-up
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 12,18,24 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Derived from this study: PubMed 38965464Yang CH, Lee J, Wilcox S, Rudisill AC, Friedman DB, Hakun JG, Neils-Strunjas J, Wei J, Miller MC, Byers MD. Implementation and evaluation of a community-based mindful walking randomized controlled trial to sustain cognitive health in older African Americans at risk for dementia. BMC Geriatr. 2024 Jul 4;24(1):579. doi: 10.1186/s12877-024-05090-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Hsiang "Jason" Yang, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful walking activity in people with Cognitive Function and Aging Well, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Hsiang "Jason" Yang, PhD (803-777-1025, cy11@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function as assessed by the Montreal Cognitive Assessment (MoCA) (time frame: Baseline, 12,18,24 weeks follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06085196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.