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Completed

NCT Number: NCT03289546

The Active Mind Study

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.

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Key information

Conditions

Cognitive Impairment Behavior Cardiovascular Risk Factor Cognition Disorders Cognitive Dysfunction Mental Disorders Motor Activity Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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'.

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.

Primary outcomes

  1. Retention rates of 80% at the final follow-up visit

    Time frame: 3 months from baseline

    The investigators will consider the study feasible under this condition

  2. Number of participants who attended at least 70% of the planned sessions

    Time frame: 3 months from baseline

    The investigators will consider the study feasible under this condition

  3. Number of participants who completed 70% of the assigned individual home practice exercises

    Time frame: 3 months from baseline

    The investigators will consider the study feasible under this condition

  4. Acceptability will be assessed using a satisfaction survey

    Time frame: 3 months from baseline

    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.

Secondary outcomes

  1. Effect size on cognitive function

    Time frame: baseline, 3, 6 months

    Preliminary estimates of effect size of mindfulness training alone vs. aerobic training alone, both, or neither on changes from baseline cognitive function.

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

    Time frame: baseline, 3, 6 months

    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.

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

    Time frame: baseline, 3, 6 months

    The HADS is a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity

  4. Exploratory outcome: waist-to-hip ratio

    Time frame: baseline, 3, 6 months

    waist-to-hip ratio

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

    Time frame: baseline, 3, 6 months

    The 6 minute walking test

  6. Exploratory outcome: blood pressure

    Time frame: baseline, 3, 6 months

    blood pressure

  7. An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support

    Time frame: baseline, 3, 6 months

    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).

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2017
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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