Cognitive Control and Physical Exercise

Cognitive Function Clinical Trial

Official title:

Cognitive Control and Physical Exercise: A Multi-Modal Intervention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01183819
• Other study ID #: AAAE5848
• Secondary ID: R01AG034178
• Status: Terminated
• Phase: N/A
• First received: August 16, 2010
• Last updated: August 3, 2015
• Start date: February 2010
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognitive Function
• Day-to-Day Function

Intervention

Behavioral:
• Space Fortress
Space Fortress sessions 3 times a week for 12 weeks
• Aerobic Exercise
Aerobic Exercise 4 times a week for 12 weeks
• Stretching
Stretching/Toning exercise 4 times a week for 12 weeks.
• Control Games
Control games session 3 times a week for 12 weeks

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in measures of executive control function and episodic memory at 6 months	tests of global intelligence, executive function, working memory and processing speed	Baseline and 12 weeks	No
Secondary	Changes in brain structure, resting cerebral blood flow and network efficiency at 6 months	structural MRI (for gray matter density), resting CBF (arterial spin labeling) and cognitive activation fMRI studies	Baseline and 12 weeks	No
Secondary	Change in aerobic capacity at 6 months	aerobic capacity as measured by VO2 max	Baseline and 12 weeks	No
Secondary	Changes in measures of executive control function and episodic memory at 1 year	tests of global intelligence, executive function, working memory and processing speed	Baseline and 52 weeks	No