The Active Mind Study

NCT03289546 | Completed DMC

• 1 other identifier: 201602917
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Cardiovascular Risk Factor

Keywords

mindfulness; exercise; cognitive function

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Effect size on cognitive function

  baseline, 3, 6 months

• An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)

  baseline, 3, 6 months

• An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)

  baseline, 3, 6 months

• Exploratory outcome: waist-to-hip ratio

  baseline, 3, 6 months

• An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test

  baseline, 3, 6 months

Study Arms (4)

Mindfulness training only

EXPERIMENTAL

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

Behavioral: Mindfulness training

Aerobic training only

EXPERIMENTAL

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

Behavioral: Aerobic training

mindfulness + aerobic training

EXPERIMENTAL

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; Behavioral: Aerobic training

Usual care

NO INTERVENTION

Interventions

Mindfulness training 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'.

Mindfulness training only; mindfulness + aerobic training

Aerobic training 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.

Aerobic training only; mindfulness + aerobic training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• 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.

  PMID: 29794738 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Elena Salmoirago-Blotcher, PhD, MD

  The Miriam Hospital & Warren Alpert Medical School at Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Medicine

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: September 21, 2017
• Study Start: April 1, 2016
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)