NCT03750903

Brief Summary

The objective of the current proposal is to identify 1) how aging-related changes in GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may improve inhibitory function and facilitate motor learning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

November 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 3, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

4.6 years

First QC Date

November 20, 2018

Results QC Date

December 3, 2024

Last Update Submit

April 1, 2025

Conditions

Keywords

aging

Outcome Measures

Primary Outcomes (1)

  • Magnetic Resonance Spectroscopy

    Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.

    Baseline and12 weeks

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.

Behavioral: Aerobic Exercise

Stretching and Balance Training

ACTIVE COMPARATOR

Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.

Behavioral: Stretching and Balance Training

Interventions

Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.

Also known as: AE; Exercise
Aerobic Exercise

Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.

Also known as: BAL; Balance
Stretching and Balance Training

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • living persons aged 50-85

You may not qualify if:

  • unmanaged diabetes
  • participants completing vigorous exercise per week
  • participants whose profession requires vigorous physical labor
  • contraindication to magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Washington, 30033-4004, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

COVID-19 impacted the in person exercise interventions

Results Point of Contact

Title
Dr. Joe Nocera, PI
Organization
Department of Veterans Affairs

Study Officials

  • Joe R. Nocera, PhD

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two group parallel design
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 23, 2018

Study Start

March 4, 2019

Primary Completion

September 30, 2023

Study Completion

September 30, 2024

Last Updated

April 3, 2025

Results First Posted

April 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations