NCT03114150

Brief Summary

Given the accelerating growth of older adults worldwide and the decline in cognitive function with aging, therapeutics that remediate age-related cognitive decline are needed more than ever. The proposed research seeks to better understand and enhance the detection of exercise effects on hippocampal network function and learning and memory, which decline with aging and Alzheimer's. Success would lead to new ways to detect benefits of exercise on cognitive aging and would lead to mechanistic insight on how such plasticity is possible while also informing prevention strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 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

First Submitted

Initial submission to the registry

March 30, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

July 1, 2025

Enrollment Period

5.1 years

First QC Date

March 30, 2017

Results QC Date

January 11, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

physical activityaginglearning and memoryexercisebrain

Outcome Measures

Primary Outcomes (1)

  • Change in Hippocampal-dependent Learning

    Learning rate on constructs that have been examined in animal models including context acquisition, episodic associations, and spatial navigation. The primary outcome is reported for the spatial navigation task that is associated with hippocampal structure and function, which is learning in the wayfinding condition. We report change in slope for wayfinding learning trials. The slope is computed based on the proportion of items correctly recalled on a map, over four learning trials. For each trial, proportion correct can range from 0 to 1, and a higher number represents faster learning, which is better.

    Baseline, 24-weeks

Secondary Outcomes (3)

  • Change in Hippocampal-cortical Functional Connectivity

    Baseline, 30 minutes

  • Change in Hippocampal-cortical Functional Connectivity

    Baseline, 24-weeks

  • Change in Cardiorespiratory Fitness

    Baseline, 24-weeks

Study Arms (2)

Cardiorespiratory fitness training

EXPERIMENTAL

Cardiorespiratory fitness training will be a 24-week supervised cycling program designed to improve cardiorespiratory fitness, with supervision directly from the 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 light intensity cycling, and 5 minute cool-down per session, for 3 sessions/week. In each additional week, 6 minutes of moderate intensity cycling per session will be added, 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: Cardiorespiratory fitness training

Functional fitness training

ACTIVE COMPARATOR

Functional fitness training will be a 24-week supervised exercise program designed to focus on functional flexibility and mobility, 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 of light intensity cycling and 20 minutes of dynamic stretching to increase range of motion and functional fitness, for 3 sessions/week. In each additional week, additional stretches will be added to maintain variety and improve flexibility of all major muscle groups.

Behavioral: Functional fitness training

Interventions

Physical exercise of moderate intensity designed to improve cardiorespiratory fitness

Cardiorespiratory fitness training

Physical exercise of light intensity designed to improve functional fitness

Functional fitness training

Eligibility Criteria

Age55 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.
  • 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.
  • Exercising less than 60 minutes a week for the past calendar year

You may not qualify if:

  • Not between the ages of 55 and 80 years old
  • Not fluent in English
  • Score \< 20 (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
  • 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)

University of Iowa

Iowa City, Iowa, 52242-1401, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Michelle Voss, Study Principal Investigator
Organization
The University of Iowa

Study Officials

  • Michelle W Voss, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 14, 2017

Study Start

May 1, 2018

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

August 13, 2025

Results First Posted

August 13, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

In accord with NIH regulations, the investigators will make the data and relevant documentation available to other investigators upon acceptance of the main findings from the study for publication. The investigators will share analysis tools as they are developed. 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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
We will share baseline neuroimaging data and phenotypic data upon completion of data collection. We will share the intervention outcome data after we have published our results from each primary aim.
Access Criteria
We will share on an open platform such as OpenNeuro (https://openneuro.org/).

Locations