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Cognitive ImpairmentNCT03289546

The Active Mind Study

A study testing Mindfulness training and Aerobic training in people with Cognitive Impairment and Cardiovascular Risk Factor, run by The Miriam Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Mindfulness training and Aerobic training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
1 Apr 2016to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Miriam Hospital

    Providence, Rhode Island, 02906

Other trials in United States

About this study

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

Read the 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.

Being tested
Mindfulness training, Aerobic training
Keywords
mindfulness, exercise, cognitive function
Medical subject headings
Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness trainingBehavioural

    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 trainingBehavioural

    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.

Study groups in NCT03289546
Study groupRoleWhat they receive
Mindfulness training onlyExperimental1 mindfulness training class (1 hour) every week for 8 weeks.
Receives: Behavioral: Mindfulness training
Aerobic training onlyExperimental3 aerobic training sessions (1 hour) per week for 12 weeks.
Receives: Behavioral: Aerobic training
mindfulness + aerobic trainingExperimental2 aerobic training sessions + 1 mindfulness training class every week for 8 weeks, then continue with 3 aerobic training sessions/ week for 4 additional weeks.
Receives: Behavioral: Mindfulness training; Behavioral: Aerobic training
Usual careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The investigators will consider the study feasible under this condition

    Measured: 3 months from baseline

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

    The investigators will consider the study feasible under this condition

    Measured: 3 months from baseline

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

    The investigators will consider the study feasible under this condition

    Measured: 3 months from baseline

  4. 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.

    Measured: 3 months from baseline

Secondary outcomes (7)

  1. 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.

    Measured: baseline, 3, 6 months

  2. 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.

    Measured: baseline, 3, 6 months

  3. 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

    Measured: baseline, 3, 6 months

  4. Exploratory outcome: waist-to-hip ratio

    waist-to-hip ratio

    Measured: baseline, 3, 6 months

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

    The 6 minute walking test

    Measured: baseline, 3, 6 months

  6. Exploratory outcome: blood pressure

    blood pressure

    Measured: baseline, 3, 6 months

  7. 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).

    Measured: baseline, 3, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2017
  2. Study start1 Apr 2016
  3. Primary completion30 Nov 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03289546
Sponsor's protocol ID
201602917
Status last verified
Feb 2019
First submitted
23 Mar 2017
Last updated
20 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29794738

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness training and Aerobic training in people with Cognitive Impairment and Cardiovascular Risk Factor, run by The Miriam Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention rates of 80% at the final follow-up visit (time frame: 3 months from baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03289546, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.

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