NCT02433691

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

2.4 years

First QC Date

April 13, 2015

Last Update Submit

April 30, 2018

Conditions

Keywords

(An)aerobic exercisememory trainingcognitive benefits

Outcome Measures

Primary Outcomes (1)

  • Effects of the MET interventions on cognition (comparing baseline vs. end-of-study NP testing)

    Change from baseline in composite measure of memory related tasks including retention, attention, and mood.

    up to 9 months

Secondary Outcomes (2)

  • Changes in BDNF levels in response to the interventions

    up to 9 months

  • Physical health measures

    up to 9 months

Study Arms (3)

Sequential Exercise and Memory Training

ACTIVE COMPARATOR

Aerobic exercise via stationary bicycling followed by memory training.

Other: sequential aerobic exercise

Simultaneous Exercise & Memory Training

EXPERIMENTAL

Simultaneous aerobic exercise via stationary bicycling while receiving memory training.

Other: simultaneous aerobic exercise

Stretching and Toning

PLACEBO COMPARATOR

Anerobic stretching and toning followed by memory training

Other: stretching and toning

Interventions

stationary bicycling at 65% of heart rate reserve for 30 minutes while receiving memory training.

Simultaneous Exercise & Memory Training

stationary bicycling at 65% of heart rate reserve for 30 minutes followed by memory training.

Sequential Exercise and Memory Training

anaerobic stretching and toning followed by memory training.

Stretching and Toning

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Longevity Center

Los Angeles, California, 90095, United States

Location

Related Publications (11)

  • Miller KJ, Siddarth P, Gaines JM, Parrish JM, Ercoli LM, Marx K, Ronch J, Pilgram B, Burke K, Barczak N, Babcock B, Small GW. The memory fitness program: cognitive effects of a healthy aging intervention. Am J Geriatr Psychiatry. 2012 Jun;20(6):514-23. doi: 10.1097/JGP.0b013e318227f821.

  • Barnes DE, Yaffe K, Satariano WA, Tager IB. A longitudinal study of cardiorespiratory fitness and cognitive function in healthy older adults. J Am Geriatr Soc. 2003 Apr;51(4):459-65. doi: 10.1046/j.1532-5415.2003.51153.x.

  • Erickson KI, Miller DL, Roecklein KA. The aging hippocampus: interactions between exercise, depression, and BDNF. Neuroscientist. 2012 Feb;18(1):82-97. doi: 10.1177/1073858410397054. Epub 2011 Apr 29.

  • Goodwin VA, Richards SH, Taylor RS, Taylor AH, Campbell JL. The effectiveness of exercise interventions for people with Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2008 Apr 15;23(5):631-40. doi: 10.1002/mds.21922.

  • Hillman CH, Erickson KI, Kramer AF. Be smart, exercise your heart: exercise effects on brain and cognition. Nat Rev Neurosci. 2008 Jan;9(1):58-65. doi: 10.1038/nrn2298.

  • Petzinger GM, Fisher BE, McEwen S, Beeler JA, Walsh JP, Jakowec MW. Exercise-enhanced neuroplasticity targeting motor and cognitive circuitry in Parkinson's disease. Lancet Neurol. 2013 Jul;12(7):716-26. doi: 10.1016/S1474-4422(13)70123-6.

  • Barnes DE, Santos-Modesitt W, Poelke G, Kramer AF, Castro C, Middleton LE, Yaffe K. The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults. JAMA Intern Med. 2013 May 13;173(9):797-804. doi: 10.1001/jamainternmed.2013.189.

  • Oswald WD, Rupprecht R, Gunzelmann T, Tritt K. The SIMA-project: effects of 1 year cognitive and psychomotor training on cognitive abilities of the elderly. Behav Brain Res. 1996 Jun;78(1):67-72. doi: 10.1016/0166-4328(95)00219-7.

  • Berchtold NC, Castello N, Cotman CW. Exercise and time-dependent benefits to learning and memory. Neuroscience. 2010 May 19;167(3):588-97. doi: 10.1016/j.neuroscience.2010.02.050. Epub 2010 Feb 26.

  • Rasmussen P, Brassard P, Adser H, Pedersen MV, Leick L, Hart E, Secher NH, Pedersen BK, Pilegaard H. Evidence for a release of brain-derived neurotrophic factor from the brain during exercise. Exp Physiol. 2009 Oct;94(10):1062-9. doi: 10.1113/expphysiol.2009.048512. Epub 2009 Aug 7.

  • McEwen SC, Siddarth P, Rahi B, Kim Y, Mui W, Wu P, Emerson ND, Lee J, Greenberg S, Shelton T, Kaiser S, Small GW, Merrill DA. Simultaneous Aerobic Exercise and Memory Training Program in Older Adults with Subjective Memory Impairments. J Alzheimers Dis. 2018;62(2):795-806. doi: 10.3233/JAD-170846.

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah McEwen, Ph.D.

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

April 13, 2015

First Posted

May 5, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations