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Effects of Exercise Intervention on Aging-related Motor Decline (EIAMD)

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ClinicalTrials.gov Identifier: NCT01787292
Recruitment Status : Active, not recruiting
First Posted : February 8, 2013
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

February 5, 2013
February 8, 2013
June 27, 2018
January 14, 2013
December 31, 2017   (Final data collection date for primary outcome measure)
Motor Dexterity Score Improvement [ Time Frame: 12 weeks ]
Motor dexterity will be improved with finger coordination training.
Same as current
Complete list of historical versions of study NCT01787292 on ClinicalTrials.gov Archive Site
  • Interhemispheric Inhibition Improvement after Exercise [ Time Frame: 12 Weeks ]
    Participants who exercise will evidence increased levels of interhemispheric inhibition as assessed by transcranial magnetic stimulation and functional magnetic resonance imaging.
  • Enhanced Interhemispheric Inhibition Improvement after Long Term Exercise [ Time Frame: 6 months ]
    Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by transcranial magnetic stimulation and functional magnetic resonance imaging after a six month, self-directed exercise intervention.
Same as current
Not Provided
Not Provided
 
Effects of Exercise Intervention on Aging-related Motor Decline
Effects of Exercise Intervention on Aging-related Motor Decline (AGING)

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.

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 cohor). 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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Aging
  • Exercise
  • Behavioral: Coordination training
    finger movement coordination training using sequenced finger movements of varying pressure.
  • Behavioral: Short Term exercise - supervised
    Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
  • Behavioral: Long Term Exercise
    6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling)
  • Experimental: Motor coordination training
    Finger movement coordination training using sequenced finger movements of varying pressure.
    Intervention: Behavioral: Coordination training
  • Experimental: Exercise - cycling
    3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum
    Intervention: Behavioral: Short Term exercise - supervised
  • Active Comparator: Waiting period
    12 week enrollment waiting period after which treatment arms will begin
    Interventions:
    • Behavioral: Coordination training
    • Behavioral: Short Term exercise - supervised
    • Behavioral: Long Term Exercise
  • Experimental: Long-term exercise - cycling
    6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling)
    Intervention: Behavioral: Long Term Exercise
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Same as current
October 1, 2018
December 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 85 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01787292
E0956-W
2012-060697 ( Other Grant/Funding Number: Veterans Affairs )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Keith M. McGregor, PhD Atlanta VA Medical and Rehab Center, Decatur, GA
VA Office of Research and Development
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP