Memory and Exercise Training Study in Older Adults With Subjective Memory Complaints (MET)

April 30, 2018 updated by: David Merrill, MD, PhD

Simultaneous Aerobic Exercise and Memory Training in Older Adults With Subjective Memory Complaints

This pilot study is a first step in a rapidly growing area of clinical research to create the most effective means to combat age-related losses in cognitive function through preventive lifestyle strategies such as physical exercise and memory training. This study will develop innovative simultaneous exercise and memory training programs in non-demented volunteers with subjective memory complaints (controls or MCI). Our primary goal is to assess the cognitive impact of 4-week memory training programs done twice weekly: 1. during simultaneous aerobic exercise (SIM-AR-MET), 2. sequentially after aerobic exercise (SEQ-AR-MET), or 3. without aerobic exercise (replaced with sequential stretching and toning) (SEQ-ST-MET). The investigators will also measure potential metabolic (e.g., glucose, lipid panel) and molecular (serum BDNF) mediators of observed cognitive changes in a subset of participants (those at the UCLA CTRC/IPCN site).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 90 non-demented healthy older adult volunteers (age 60-75) with subjective memory complaints (controls or MCI) will be screened and enrolled into the study. The CTRC/IPCN site will enroll 30 subjects (10 in each group); the MPTF site will enroll 60 subjects (20 in each group). Baseline assessments will include neuropsychological testing of all study subjects. At UCLA CTRC/IPCN, baseline assessments will also include cardiorespiratory fitness, body composition, YMCA fitness tests, and blood-based markers of metabolism and plasticity. To control for total activity levels, all study subjects will wear continuous physical activity monitors (FitBit accelerometers) and keep exercise and cognitive activity logs during the entire study. All subjects (n = 90) will first complete a 1-week observational period to capture baseline activity levels. Subjects will then be randomized to one of three groups: SIM-AR-E&MT, SEQ-AR-E&MT, or SEQ-ST-MET (n = 30 per group). SIM-AR-MET and SEQ-AR-MET subjects will complete a 3-week exercise only 'ramp-up' period consisting of twice weekly 1-hour sessions practicing stationary bicycling, improving cardiovascular fitness enough to complete the upcoming 4-weeks of MET sessions (described below), and practicing stretching and toning; SEQ-ST-MET subjects 3-week exercise only 'ramp-up' period will consist of an equal number of six stretching and toning sessions (no aerobic components). All 3 programs will then have two 2-hour sessions per week for 4 weeks. The SIM-AR-MET and SEQ-ST-MET subjects will do stretching/toning during the first hour; SEQ-AR-MET subjects will do aerobic cycling during the first hour. During the second half of the sessions, all 3 groups will first learn new memory training strategies while sedentary. SIM-AR-MET subjects will then practice the memory techniques while cycling while SEQ-AR-MET and SEQ-ST-MET subjects will practice the memory techniques while still sedentary. The three groups will have group specific exercise and memory training homework assignments, along with monitoring of activity and logging of cognitively enriching activities. The NP testing will be done again at the end of the 4 weeks of memory training classes for all study subjects. UCLA CTRC/IPCN subjects will have the additional testing done at baseline (e.g., blood-based markers, etc.).

Consideration was given to having a purely observational 'wait-list' group, but in our experience with this population such groups have typically initiated greater levels of self-guided exercise and memory training in reaction to being put on a wait list. Alternatively, if no increase in activity or memory training is undertaken by wait list subjects, the investigators would not expect any differences in cognitive performance to be measurable within the brief 3 month total time frame of this initial study. The investigators also considered have a group do aerobic exercise immediately after memory training, but based on current literature, this combination seemed the least likely to impact memory synergistically. Thus, these two groups will be deferred for the pilot until later, larger studies can be done to confirm or refute these hypotheses. Similarly, while our primary aim assessing change in NP performance will be tested in all subjects, the pilot nature of the study prohibits testing of secondary aims in both sites. The academic medical center site will leverage the assistance of the UCLA CTRC/IPCN to accomplish preliminary testing of the secondary aims in 30 subjects, while the UCLA MPTF community site will test only the primary study aim of change in NP performance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Longevity Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In good health
  • Have memory problems or complaints
  • Living independently

Exclusion Criteria:

  • History of neurodegenerative disease or dementia
  • Major psychiatric conditions
  • Neurological disorders
  • Active alcohol or substance abuse
  • Head trauma or systemic diseases affecting brain function
  • Uncontrolled hypertension or cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sequential Exercise and Memory Training
Aerobic exercise via stationary bicycling followed by memory training.
Other: sequential aerobic exercise
stationary bicycling at 65% of heart rate reserve for 30 minutes followed by memory training.
Experimental: Simultaneous Exercise & Memory Training
Simultaneous aerobic exercise via stationary bicycling while receiving memory training.
Other: simultaneous aerobic exercise
stationary bicycling at 65% of heart rate reserve for 30 minutes while receiving memory training.
Placebo Comparator: Stretching and Toning
Anerobic stretching and toning followed by memory training
Other: stretching and toning
anaerobic stretching and toning followed by memory training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effects of the MET interventions on cognition (comparing baseline vs. end-of-study NP testing)
Time Frame: up to 9 months
Change from baseline in composite measure of memory related tasks including retention, attention, and mood.
up to 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in BDNF levels in response to the interventions
Time Frame: up to 9 months
Increase of baseline measurement for BDNF levels.
up to 9 months
Physical health measures
Time Frame: up to 9 months
Change in baseline in composite measurement of weight (loss), and increase in physical activity.
up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
David Merrill, MD, PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah McEwen, Ph.D., UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-001411

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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