The Active Mind Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exploring Synergistic Effects Of Aerobic Exercise And Mindfulness Training On Cognitive Function In Older Adults: A Pilot, Proof Of Concept Study

Conditions
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Cognitive Impairment, Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Mindfulness training
* Behavioral: Aerobic training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥55 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 Cognitive complaint defined as answering yes to the question do you feel that your memory or thinking skills have gotten worse recently? Fluency in English language Exclusion Criteria: Unwillingness/inability to provide informed consent Contraindications to physical activity as per the participant's PCP assessment Blood pressure >200/110 Severe depressive symptoms (defined as Hospital Anxiety and Depression Scale [HADS] depression subscale scores >14) Acute psychosis (from medical record) Severe cognitive impairment (Mini-Mental State Examination [MMSE] score <24) Recent hospitalization (< 6 weeks) Current (at least once a month) mind/body practice (i.e., mindfulness meditation, yoga, or tai chi)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness training only<br>1 mindfulness training class (1 hour) every week for 8 weeks. | Behavioral: Mindfulness training<br>* The mindfulness training protocol will include the following basic components of traditional mindfulness-based stress reduction training: 1) training in awareness of sensations (body scan); 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life, and in recognizing when the attention is no longer focused on a specific object of attention; and 4) training in 'open awareness'.<br>|
| Experimental: Aerobic training only<br>3 aerobic training sessions (1 hour) per week for 12 weeks. | Behavioral: Aerobic training<br>* Exercise sessions will be led by CPR- and exercise-certified YMCA instructors and supervised by the senior research assistant. Sessions will consist of 10 minutes of warm-up, 40 minutes of aerobic exercise (walking on a treadmill), 10 minutes of cool down and stretching. Participants will receive heart monitors at the beginning of the study and will be trained by the senior research assistant to exercise targeting heart rates at 65-75% of the age predicted max heart rate or at an intensity of 12-13 in the Borg scale of the rate of perceived exertion.<br>|
| Experimental: mindfulness + aerobic training<br>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. | Behavioral: Mindfulness training<br>* The mindfulness training protocol will include the following basic components of traditional mindfulness-based stress reduction training: 1) training in awareness of sensations (body scan); 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life, and in recognizing when the attention is no longer focused on a specific object of attention; and 4) training in 'open awareness'.<br>Behavioral: Aerobic training<br>* Exercise sessions will be led by CPR- and exercise-certified YMCA instructors and supervised by the senior research assistant. Sessions will consist of 10 minutes of warm-up, 40 minutes of aerobic exercise (walking on a treadmill), 10 minutes of cool down and stretching. Participants will receive heart monitors at the beginning of the study and will be trained by the senior research assistant to exercise targeting heart rates at 65-75% of the age predicted max heart rate or at an intensity of 12-13 in the Borg scale of the rate of perceived exertion.<br>|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rates of 80% at the final follow-up visit | The investigators will consider the study feasible under this condition | 3 months from baseline | 
| Number of participants who attended at least 70% of the planned sessions | The investigators will consider the study feasible under this condition | 3 months from baseline | 
| Number of participants who completed 70% of the assigned individual home practice exercises | The investigators will consider the study feasible under this condition | 3 months from baseline | 
| Acceptability will be assessed using a satisfaction survey | Acceptability will be assessed using a satisfaction survey. The intervention will be considered acceptable if ≥80% of participants responds that they are at least somewhat satisfied with the intervention. | 3 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect size on cognitive function | Preliminary estimates of effect size of mindfulness training alone vs. aerobic training alone, both, or neither on changes from baseline cognitive function. | baseline, 3, 6 months | 
| An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form) | Five Facets of Mindfulness questionnaire (short form) is a 12-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. | baseline, 3, 6 months | 
| An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) | The HADS is a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity | baseline, 3, 6 months | 
| Exploratory outcome: waist-to-hip ratio | waist-to-hip ratio | baseline, 3, 6 months | 
| An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test | The 6 minute walking test | baseline, 3, 6 months | 
| Exploratory outcome: blood pressure | blood pressure | baseline, 3, 6 months | 
| An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support | A 12-item, uni-dimensional tool to measure how one perceives their social support system, including individuals sources of social support (i.e., family, friends, and significant other). | baseline, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, exercise, cognitive function