NCT01787292

Brief Summary

The purpose of this research study is to test whether differing levels of physical fitness affects patterns of motor dexterity and brain activity that have been shown to differ due to aging. Testing will take place at the Atlanta VA Medical Center and at Emory University. Participants will be healthy adults within the target age range of 60-85 for the study. The study will require multiple visits over 15 months. There will be about 64 people volunteering for this study.

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 Jan 2013

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

Study Start

First participant enrolled

January 14, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

5.5 years

First QC Date

February 5, 2013

Results QC Date

September 23, 2019

Last Update Submit

February 5, 2020

Conditions

AgingExercise

Keywords

ExerciseMagnetic Resonance ImagingTranscranial Magnetic StimulationAging

Outcome Measures

Primary Outcomes (10)

  • Estimate Cardiovascular Efficiency After Aerobic Exercise

    Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment.

    Baseline, 12 weeks, 24 weeks

  • Estimate of Cardiovascular Efficiency After Balance Training

    Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes.

    Baseline, 12 weeks, 24 weeks

  • Silent Period Duration After Exercise Cycling Program

    Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds

    Baseline, 12 weeks, 24 weeks

  • Silent Period Duration for Balance Group

    Ipsilateral silent period duration as assessed by TMS

    Baseline, 12 weeks, 24 weeks

  • fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise

    Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by functional magnetic resonance measured by a z-normalized area under curve of right primary motor cortex. The area under the curve is an estimate of the fMRI hemodynamic response impulse response function. A higher number of AUC indicates less interhemispheric inhibition. In contrast, a lower number in this analysis indicates higher interhemispheric inhibition.

    Baseline to 24 Weeks with cross-over

  • fMRI Interhemispheric Inhibition Improvement After Balance Training

    Area under the curve of fMRI measures of right motor cortex BOLD profile will remain similar to pre measurements. The BOLD profile is the z-normalized area under the curve value of the fMRI impulse response function. A higher number indicates less interhemispheric inhibition.

    Baseline, 12 weeks, 24 weeks

  • Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention

    Comparison of home based aerobic exercise intervention to assessments made after completion of crossover intervention in Participants receiving aerobic condition first. VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. Estimated VO2 peak values are in ml/kg(min).

    24 and 48 weeks

  • Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention

    VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads.

    24 and 48 weeks

  • Comparison of Silent Period Duration After Aerobic Exercise

    Comparison of silent period duration at 24 weeks compared to baseline

    Baseline, 12 weeks, 24 weeks

  • Comparison of Silent Period Duration After Balance Exercise

    Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs.

    24 and 48 weeks

Secondary Outcomes (3)

  • Target Heart Rate Zone for Balance First Participants

    24 and 48 weeks

  • Target Heart Rate Zone After Aerobic Exercise First

    24 and 48 weeks

  • Heart Rate Workload After Home Based Intervention

    24 and 48 weeks

Study Arms (3)

Stretching Exercise Intervention

EXPERIMENTAL

A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.

Behavioral: Stretching Exercise Intervention

Aerobic Exercise Intervention

EXPERIMENTAL

B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum.

Behavioral: Aerobic Exercise Intervention

Self Monitoring Intervention

EXPERIMENTAL

C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer.

Behavioral: Self Monitoring

Interventions

Stretching Exercise InterventionBEHAVIORAL

A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.

Stretching Exercise Intervention
Aerobic Exercise InterventionBEHAVIORAL

Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.

Aerobic Exercise Intervention
Self MonitoringBEHAVIORAL

6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling)

Self Monitoring Intervention

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living persons between 60 and 85 years of age

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, Georgia, 30033, United States

Location

Related Publications (3)

  • McGregor KM, Crosson B, Mammino K, Omar J, Garcia PS, Nocera JR. Influences of 12-Week Physical Activity Interventions on TMS Measures of Cortical Network Inhibition and Upper Extremity Motor Performance in Older Adults-A Feasibility Study. Front Aging Neurosci. 2018 Jan 4;9:422. doi: 10.3389/fnagi.2017.00422. eCollection 2017.

    PMID: 29354049RESULT

  • Nocera J, Crosson B, Mammino K, McGregor KM. Changes in Cortical Activation Patterns in Language Areas following an Aerobic Exercise Intervention in Older Adults. Neural Plast. 2017;2017:6340302. doi: 10.1155/2017/6340302. Epub 2017 Mar 6.

    PMID: 28367334RESULT

  • McGregor KM, Crosson B, Krishnamurthy LC, Krishnamurthy V, Hortman K, Gopinath K, Mammino KM, Omar J, Nocera JR. Effects of a 12-Week Aerobic Spin Intervention on Resting State Networks in Previously Sedentary Older Adults. Front Psychol. 2018 Nov 27;9:2376. doi: 10.3389/fpsyg.2018.02376. eCollection 2018.

    PMID: 30542314RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative Techniques

Limitations and Caveats

Local procurement difficulties limited remote tracking of participants in 6-month home exercise arm of program. This caused lower-than-expected adherence and negatively affected long-term outcomes.

Results Point of Contact

Title
Dr. Keith McGregor
Organization
Health Science Specialist
keith.mcgregor2@va.gov
4043216111

Study Officials

  • Keith M. McGregor, PhD MS BA

    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
CROSSOVER
Model Details: A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum. C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 8, 2013

Study Start

January 14, 2013

Primary Completion

July 7, 2018

Study Completion

August 1, 2019

Last Updated

February 20, 2020

Results First Posted

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)