Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01787292
Other study ID # E0956-W
Secondary ID 2012-060697
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2013
Est. completion date August 1, 2019

Study information

Verified date February 2020
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The U.S. Census reports over 14 million U.S. Veterans (>63%) are beyond mid-life (>55 years). Declines in upper extremity motor performance respective of strength and dexterity are well documented within this age cohort). Recent cross-sectional research has discovered that aging related motor deficits may be influenced by a loss of interhemispheric inhibition (IHI) between primary motor cortices. However, this loss may not be an inevitable consequence of aging. Work from previous VA OAA Predoctoral and CDA-1 awards have shown that aerobic fitness may serve to mitigate losses in interhemispheric inhibition assessed by both functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS). That is, individuals who are aerobically fit show higher levels of IHI and improved dexterity and reaction times.

In light of new evidence from the investigators' lab's recent cross-sectional studies, physical activity over the long term (at least 2-5 years) may serve to alter levels of IHI and improve motor performance in the upper extremity. Aerobic exercise may provide a mechanism (reduced loss of interhemispheric inhibition) that could serve to improve motor function, but the neural mechanism responsible for such effects remains unclear. Previous investigations of interhemispheric communication and exercise have been limited by nature of inquiry, as cross-sectional research cannot measure changes over time in participants. As such, it is currently unknown how exercise may directly affect levels of interhemispheric communication and motor performance.

Behavioral interventions (motor strength and coordination) have been shown to be effective in improving upper extremity motor performance in older adults, however the duration of these gains appear to be short-lived. After as little as a few weeks of detraining, motor strength and coordination in the upper extremity rapidly begins to return to pre-intervention levels. Evidence from exercise interventions assessing gait and locomotion have shown that exercise programs over a longer term (>6 months) are associated with improved proprioception, fewer falls and better balance. However, the comparison of outcomes of upper extremity function in elderly adults respective of exercise duration remains largely unexplored. In addition to comparing the effects of short-term exercise (3 months) versus behavioral training (3 months) on upper extremity function, the current proposal will evaluate if a longer-term (6 months) exercise program can maintain or enhance upper extremity function and associated levels of interhemispheric inhibition.

The current study proposes the next logical step in my line of research and directly investigates the effects of exercise in an intervention with sedentary older Veterans (50-80 years), a group most likely to exhibit aging-related motor deficits. The investigators propose to enroll 40 Veterans into an upper extremity dexterity improvement program involving behavioral and exercise components. The behavioral intervention is a muscle coordination training previously shown to improve unimanual motor performance in older adults. The exercise intervention is a supervised group cycling regimen. The figure below shows the study design. Interhemispheric communication will be assessed with fMRI, and TMS.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date August 1, 2019
Est. primary completion date July 7, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria:

- Living persons between 60 and 85 years of age

Exclusion Criteria:

- unmanaged diabetes

- participants completing vigorous exercise per week

- participants whose profession requires vigorous physical labor

- contraindication to magnetic resonance imaging

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stretching Exercise Intervention
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.
Aerobic Exercise Intervention
Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
Self Monitoring
6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling)

Locations

Country Name City State
United States Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Georgia

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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;9:23 — View Citation

McGregor KM, Crosson B, Mammino K, Omar J, García 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 Ne — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Estimate Cardiovascular Efficiency After Aerobic Exercise Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment. Baseline, 12 weeks, 24 weeks
Primary Estimate of Cardiovascular Efficiency After Balance Training Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes. Baseline, 12 weeks, 24 weeks
Primary Silent Period Duration After Exercise Cycling Program Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds Baseline, 12 weeks, 24 weeks
Primary Silent Period Duration for Balance Group Ipsilateral silent period duration as assessed by TMS Baseline, 12 weeks, 24 weeks
Primary 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
Primary 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
Primary 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
Primary 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
Primary Comparison of Silent Period Duration After Aerobic Exercise Comparison of silent period duration at 24 weeks compared to baseline Baseline, 12 weeks, 24 weeks
Primary 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 Target Heart Rate Zone for Balance First Participants Heart rate in aerobic target zone is measured in percentage of time in at least 50% of participants heart rate reserve. 24 and 48 weeks
Secondary Target Heart Rate Zone After Aerobic Exercise First Targeted Heart Rate Zone among participants compared among short term exercise groups 24 and 48 weeks
Secondary Heart Rate Workload After Home Based Intervention Measured heart rate after home based intervention
Technical implementation at the facility level prevented acquisition of these metrics until late in the project.
24 and 48 weeks
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A