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Cognitive Control and Physical Exercise

Cognitive Control and Physical Exercise: A Multi-Modal Intervention

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01183819
Enrollment
12
Registered
2010-08-18
Start date
2010-02-28
Completion date
2015-06-30
Last updated
2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function, Day-to-Day Function

Keywords

cognitive function, fMRI, apoE, inflammatory markers, exercise, cognitive intervention, Space Fortress

Brief summary

The purpose of this study is to test the hypothesis that aerobic exercise and a computer-based cognitive intervention leads to improved cognitive function accompanied by increases in gray matter density and changes in functional magnetic resonance imaging (fMRI) patterns of task-related activation.

Detailed description

Epidemiological evidence suggest that a set of lifetime exposures including educational and occupational attainment and leisure activities later in life are associated with more preserved cognitive and day-to-day functioning and reduced risk of dementia. However, the specific set of activities that can maintain or improve function in late life are relatively unexplored. In the current study, we will test the combined efficacy of two such activities: cognitive training and aerobic exercise. These activities have been shown to increase cognitive function and brain plasticity, respectively. The cognitive intervention that we will use is training with the Space Fortress task. This task is aimed at improving cognitive control processes that underlie multiple activities and are particularly affected by aging. We hypothesize that combining these two interventions will produce synergistic effects that will significantly improve cognitive and day-to-day function in healthy older adults. A total of 90 cognitively-healthy older adults will be recruited and randomly assigned to one of three conditions: control video game, control exercise and combined exercise and space fortress training. A range of cognitive and day-to-day functioning will be assessed at baseline and after three months of training. We will also assess compliance with a home-based version of the training program from the end of the 3-month laboratory-based training and the effect of this compliance on measures of cognition and day-to-day functioning. We hypothesize that the interventions can be sustained over a 1-year period and that larger benefits will be observed in participants that adhere to the protocol. We also propose two complementary approaches to investigating the neural correlates of the beneficial effects of aerobic exercise on cognition: 1) imaging -- we will use a combination of structural, metabolic, and cognitive activation fMRI studies to evaluate the neural substrates of the effect of aerobic exercise on cognition. 2) important correlates -- we will explore the effects of apolipoprotein E (APOE) genotype, inflammatory markers and cognitive reserve on the cognitive effects of aerobic exercise.

Interventions

BEHAVIORALSpace Fortress

Space Fortress sessions 3 times a week for 12 weeks

BEHAVIORALAerobic Exercise

Aerobic Exercise 4 times a week for 12 weeks

BEHAVIORALStretching

Stretching/Toning exercise 4 times a week for 12 weeks.

BEHAVIORALControl Games

Control games session 3 times a week for 12 weeks

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 60-75 2. English-speaking 3. Strongly right-handed 4. BMI \> 18.5 and \< 32 5. Post-menopausal (women only): no estrogen replacement therapy 6. Sedentary: VO2max \< 36 ml/kg/min for men age 60-75; \< 29 ml/kg/min for women age 60-75 (determined using Jones Formula Men = (60-(0.55\*AGE)) Women = (48-(.37\*AGE))

Exclusion criteria

1. MRI contraindications (e.g., metallic implants, pacemaker, weight \> 350 lbs, waist \> 55) 2. Hearing impaired/hearing aids, unable to read newspaper at arm's length with corrective lenses 3. Objective cognitive impairment 4. Ischemic changes, abnormal blood pressure responses, or any significant ectopy during aerobic capacity testing 5. Cardiovascular disease 6. Uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg; or diastolic blood pressure ≥ 105 mmHg on two measures) 7. Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma 8. Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II). 9. HIV infection 10. Pregnant or lactating (participation allowed 3 months after ceasing lactation 11. Other medical disorders judge to interfere with study 12. Medications that target CNS (e.g., neuroleptics, anticonvulsants, antidepressants, benzodiazepines) within the last month 13. Women: any selective estrogen receptor modulator or aromatase inhibitor Men: androgen ablation/deprivation hormonal therapies 14. Any history of psychosis or electroconvulsive therapy 15. Psychotic disorder (lifetime) 16. Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs. 17. Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury, mental retardation 18. Imaged cortical stroke or large subcortical lacunae or infarct or space-occupying lesion (≥ 2 cubic cm). Other findings, e.g., periventricular caps or small white matter hyperintensities, do not result in exclusion 19. Diagnosed learning disability, dyslexia

Design outcomes

Primary

MeasureTime frameDescription
Changes in measures of executive control function and episodic memory at 6 monthsBaseline and 12 weekstests of global intelligence, executive function, working memory and processing speed

Secondary

MeasureTime frameDescription
Changes in brain structure, resting cerebral blood flow and network efficiency at 6 monthsBaseline and 12 weeksstructural MRI (for gray matter density), resting CBF (arterial spin labeling) and cognitive activation fMRI studies
Change in aerobic capacity at 6 monthsBaseline and 12 weeksaerobic capacity as measured by VO2 max
Changes in measures of executive control function and episodic memory at 1 yearBaseline and 52 weekstests of global intelligence, executive function, working memory and processing speed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026