NCT02453178

Brief Summary

Although exercise is known to delay cognitive decline and decrease our risk of Alzheimer's Disease, there is a lack of understanding of how exercise protects the aging brain. The proposed research takes a novel approach to this problem by testing the concept that there are acute, direct effects of exercise in the same brain regions that are affected by chronic exercise training. If the investigators are successful, the acute paradigm will allow us to determine the critical exercise parameters that modulate brain function in humans using only a single exercise dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

April 25, 2015

Last Update Submit

January 26, 2018

Conditions

Keywords

physical activityagingcognitionbrainexercise

Outcome Measures

Primary Outcomes (1)

  • Functional brain network integrity: the strength of the correlation between fluctuating functional magnetic resonance imaging (fMRI) signal in different brain regions of the Default Mode Network (DMN) and the Executive Control Network (ECN) at rest

    Resting state brain networks known to be vulnerable to decline with normal aging

    Change from baseline functional network integrity at 12-weeks

Secondary Outcomes (4)

  • Motor learning rate

    Change from baseline learning rate at 12-weeks

  • Explicit paired associates learning rate

    Change from baseline learning rate at 12-weeks

  • Executive function composite measure

    Change from baseline executive function performance at 12-weeks

  • Cardiovascular fitness measured as "Vo2 max" from a cycle ergometer test

    Change from baseline fitness at 12-weeks

Study Arms (2)

Steady state moderate intensity cycling

EXPERIMENTAL

Moderate intensity exercise training will be a 12-week supervised cycling program, with supervision directly from our research team. All participants will first receive a one-on-one orientation with an exercise training specialist that has been trained by Dr. Gary Pierce in monitoring an exercise program for healthy older adults. Training will start with a 5 minute-warm-up, 20 minutes moderate intensity cycling and 30 minutes passive cycling, and 5 minute cool-down per session, for 3 sessions/week. In each additional week, we will add 6 minutes of moderate intensity cycling per session, until the total time for moderate intensity is 50 minutes per session by the start of week 5 (with additional 5 minute warm-up and 5 minute cool-down).

Behavioral: Cycling

Intermittent cycling

ACTIVE COMPARATOR

The intermittent cycling group will come to the exercise lab for the same duration and frequency each week and complete primarily passive cycling such that a motor in the stationary bicycle moves the pedals for them. To maintain interest in this intervention, we will include short bouts of moderate intensity activity. The short bouts of moderate intensity cycling will be designed to be ineffective for substantially increasing cardiorespiratory fitness over the course of the intervention.

Behavioral: Cycling

Interventions

CyclingBEHAVIORAL

The experimental group will complete a 3 month exercise program that includes working up to cycling at a moderate intensity for 50 minutes/session 3 times a week. The comparison group will complete a 3-month exercise program that includes intermittent cycling (alternating between passive and moderate intensity) for 50 minutes/session 3 times a week. Both groups will exercise in our laboratory at Spence Labs, and will be supervised by an exercise trainer that is trained in working with elderly and special populations.

Also known as: Exercise
Intermittent cyclingSteady state moderate intensity cycling

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire, and corrected vision of 20/40.
  • Because our older adult sample is over the age of 40, we will also require completion of a detailed health history questionnaire and further eligibility for the exercise intervention will be determined following approval from a physician that monitored electrocardiography (ECG) response during a maximal aerobic fitness test that is part of the second study visit described below.

You may not qualify if:

  • Not between the ages of 60 and 80 years old
  • Not fluent in English
  • Score \< 26 (out of 30) on the Montreal Cognitive Assessment (MoCA)
  • Inability to comply with experimental instructions
  • Qualify as "high risk" for acute cardiovascular event by the published standards of the American College of Sports Medicine
  • Left-handed
  • Previous diagnosis of neurological, metabolic, or psychiatric condition, and no previous brain injury associated with loss of consciousness
  • Inability to complete an MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HBC Lab

Iowa City, Iowa, 52245, United States

Location

Related Publications (1)

  • Voss MW, Weng TB, Narayana-Kumanan K, Cole RC, Wharff C, Reist L, Dubose L, Sigurdsson G, Mills JA, Long JD, Magnotta VA, Pierce GL. Acute Exercise Effects Predict Training Change in Cognition and Connectivity. Med Sci Sports Exerc. 2020 Jan;52(1):131-140. doi: 10.1249/MSS.0000000000002115.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michelle Voss, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychological and Brain Sciences

Study Record Dates

First Submitted

April 25, 2015

First Posted

May 25, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

In accord with NIH regulations, we will make the data and relevant documentation available to other investigators at their request upon acceptance of the main findings from the study for publication. Because the collected data are to remain anonymous, only a subject number will identify all data. To further protect the privacy and confidentiality of the data, data and documentation will be made available only under a data-sharing agreement that provides for restrictions for the transferring of data to others and a commitment that the data will be used for research purposes only and not for a profit-making enterprise.

Locations