The Active Mind Study

NCT ID: NCT03289546

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2018-12-31

Brief Summary

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

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.

Conditions

Cognitive Impairment; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness training only

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

Group Type: EXPERIMENTAL

Mindfulness training

Intervention Type: BEHAVIORAL

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'.

Aerobic training only

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

Group Type: EXPERIMENTAL

Aerobic training

Intervention Type: BEHAVIORAL

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.

mindfulness + aerobic training

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.

Group Type: EXPERIMENTAL

Mindfulness training

Intervention Type: BEHAVIORAL

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'.

Aerobic training

Intervention Type: BEHAVIORAL

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.

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness training

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'.

Intervention Type: BEHAVIORAL

Aerobic training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elena Salmoirago-Blotcher

Assistant professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena Salmoirago-Blotcher, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital & Warren Alpert Medical School at Brown University

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

References

Salmoirago-Blotcher E, DeCosta J, Harris K, Breault C, Dunsiger S, Santos C, Snyder P. Exploring synergistic effects of aerobic exercise and mindfulness training on cognitive function in older adults: Protocol for a pilot randomized controlled trial. Medicine (Baltimore). 2018 May;97(21):e10626. doi: 10.1097/MD.0000000000010626.

Reference Type: DERIVED

PMID: 29794738 (View on PubMed)

Other Identifiers

201602917

Identifier Type: -

Identifier Source: org_study_id