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The Active Mind Study

Primary Purpose

Cognitive Impairment, Cardiovascular Risk Factor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness training
Aerobic training
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring mindfulness, exercise, cognitive function

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Mindfulness training only

Aerobic training only

mindfulness + aerobic training

Usual care

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Retention rates of 80% at the final follow-up visit
The investigators will consider the study feasible under this condition
Number of participants who attended at least 70% of the planned sessions
The investigators will consider the study feasible under this condition
Number of participants who completed 70% of the assigned individual home practice exercises
The investigators will consider the study feasible under this condition
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.

Secondary Outcome Measures

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.
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.
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
Exploratory outcome: waist-to-hip ratio
waist-to-hip ratio
An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test
The 6 minute walking test
Exploratory outcome: blood pressure
blood pressure
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).

Full Information

First Posted
March 23, 2017
Last Updated
February 19, 2019
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03289546
Brief Title
The Active Mind Study
Official Title
Exploring Synergistic Effects Of Aerobic Exercise And Mindfulness Training On Cognitive Function In Older Adults: A Pilot, Proof Of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Cardiovascular Risk Factor
Keywords
mindfulness, exercise, cognitive function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness training only
Arm Type
Experimental
Arm Description
1 mindfulness training class (1 hour) every week for 8 weeks.
Arm Title
Aerobic training only
Arm Type
Experimental
Arm Description
3 aerobic training sessions (1 hour) per week for 12 weeks.
Arm Title
mindfulness + aerobic training
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training
Intervention Description
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
Intervention Name(s)
Aerobic training
Intervention Description
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 Outcome Measure Information:
Title
Retention rates of 80% at the final follow-up visit
Description
The investigators will consider the study feasible under this condition
Time Frame
3 months from baseline
Title
Number of participants who attended at least 70% of the planned sessions
Description
The investigators will consider the study feasible under this condition
Time Frame
3 months from baseline
Title
Number of participants who completed 70% of the assigned individual home practice exercises
Description
The investigators will consider the study feasible under this condition
Time Frame
3 months from baseline
Title
Acceptability will be assessed using a satisfaction survey
Description
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.
Time Frame
3 months from baseline
Secondary Outcome Measure Information:
Title
Effect size on cognitive function
Description
Preliminary estimates of effect size of mindfulness training alone vs. aerobic training alone, both, or neither on changes from baseline cognitive function.
Time Frame
baseline, 3, 6 months
Title
An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)
Description
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.
Time Frame
baseline, 3, 6 months
Title
An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity
Time Frame
baseline, 3, 6 months
Title
Exploratory outcome: waist-to-hip ratio
Description
waist-to-hip ratio
Time Frame
baseline, 3, 6 months
Title
An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test
Description
The 6 minute walking test
Time Frame
baseline, 3, 6 months
Title
Exploratory outcome: blood pressure
Description
blood pressure
Time Frame
baseline, 3, 6 months
Title
An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support
Description
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).
Time Frame
baseline, 3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Salmoirago-Blotcher, PhD, MD
Organizational Affiliation
The Miriam Hospital & Warren Alpert Medical School at Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29794738
Citation
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.
Results Reference
derived

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The Active Mind Study

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