The Active Mind Study

Lifespan

Status: Completed

Conditions: Cognitive Impairment; Cardiovascular Risk Factor

Treatments: Behavioral: Aerobic training; Behavioral: Mindfulness training

Study type: Interventional

Funder types: Other

Identifiers

NCT03289546

201602917

Details and patient eligibility

About

The purpose of this study is to explore whether physical exercise, mindfulness training, or both interventions together can improve cognitive function in individuals with multiple risk factors for the development of dementia in the future.

Full description

The investigators will test the feasibility and acceptability of a combined mindfulness training + aerobic training intervention, vs. either alone or none to improve cognitive function in older adults with cognitive impairment. The investigators will also obtain estimates of effect sizes (and confidence intervals) on cognitive function. Preliminary analyses will be conducted to explore the mediating role of changes in aerobic capacity, physical activity, vascular risk factors, and mindfulness skills. Assessments will be conducted at baseline, 3-, and 6- months since baseline.

Enrollment: 38 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥55
2. Being physically inactive (defined as not meeting current AHA recommendations for physical activity, i.e., < 150 min of moderate-intensity aerobic activity per week OR < 75 minutes of vigorous aerobic activity per week
3. Cognitive complaint defined as answering yes to the question "do you feel that your memory or thinking skills have gotten worse recently?"
4. Fluency in English language

Exclusion criteria

1. Unwillingness/inability to provide informed consent
2. Contraindications to physical activity as per the participant's PCP assessment
3. Blood pressure >200/110
4. Severe depressive symptoms (defined as Hospital Anxiety and Depression Scale [HADS] depression subscale scores >14)
5. Acute psychosis (from medical record)
6. Severe cognitive impairment (Mini-Mental State Examination [MMSE] score <24)
7. Recent hospitalization (< 6 weeks)
8. Current (at least once a month) mind/body practice (i.e., mindfulness meditation, yoga, or tai chi)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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38 participants in 4 patient groups

Mindfulness training only

Experimental group

Description:

1 mindfulness training class (1 hour) every week for 8 weeks.

Treatment:

Behavioral: Mindfulness training

Aerobic training only

Experimental group

Description:

3 aerobic training sessions (1 hour) per week for 12 weeks.

Treatment:

Behavioral: Aerobic training

mindfulness + aerobic training

Experimental group

Description:

2 aerobic training sessions + 1 mindfulness training class every week for 8 weeks, then continue with 3 aerobic training sessions/ week for 4 additional weeks.

Treatment:

Behavioral: Mindfulness training

Behavioral: Aerobic training

Usual care

No Intervention group