Cognitive Control and Physical Exercise

NCT01183819 | Terminated DMC

• 2 other identifiers: AAAE5848R01AG034178
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function; Day-to-Day Function

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Changes in brain structure, resting cerebral blood flow and network efficiency at 6 months

  Baseline and 12 weeks

• Change in aerobic capacity at 6 months

  Baseline and 12 weeks

• Changes in measures of executive control function and episodic memory at 1 year

  Baseline and 52 weeks

Study Arms (3)

Space Fortress and Exercise

EXPERIMENTAL

Participants engage in aerobic exercise 4 times week and Space Fortress sessions 3 times a week for a total of 12 weeks.

Behavioral: Space Fortress; Behavioral: Aerobic Exercise

Control Games and Exercise

ACTIVE COMPARATOR

Participants engage in aerobic exercise 4 times a week and control game sessions 3 times a week for a total of 12 weeks.

Behavioral: Aerobic Exercise; Behavioral: Control Games

Control Games and Stretching

ACTIVE COMPARATOR

Participants engage in stretching/toning exercises 4 times a week and control game sessions 3 times a week for a total of 12 weeks.

Behavioral: Stretching; Behavioral: Control Games

Interventions

Space Fortress BEHAVIORAL

Space Fortress sessions 3 times a week for 12 weeks

Space Fortress and Exercise

Aerobic Exercise BEHAVIORAL

Aerobic Exercise 4 times a week for 12 weeks

Control Games and Exercise; Space Fortress and Exercise

Stretching BEHAVIORAL

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

Control Games and Stretching

Control Games BEHAVIORAL

Control games session 3 times a week for 12 weeks

Control Games and Exercise; Control Games and Stretching

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60-75
• English-speaking
• Strongly right-handed
• BMI \> 18.5 and \< 32
• Post-menopausal (women only): no estrogen replacement therapy
• 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))

You may not qualify if:

• MRI contraindications (e.g., metallic implants, pacemaker, weight \> 350 lbs, waist \> 55")
• Hearing impaired/hearing aids, unable to read newspaper at arm's length with corrective lenses
• Objective cognitive impairment
• Ischemic changes, abnormal blood pressure responses, or any significant ectopy during aerobic capacity testing
• Cardiovascular disease
• Uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg; or diastolic blood pressure ≥ 105 mmHg on two measures)
• Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma
• 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).
• HIV infection
• Pregnant or lactating (participation allowed 3 months after ceasing lactation
• Other medical disorders judge to interfere with study
• Medications that target CNS (e.g., neuroleptics, anticonvulsants, antidepressants, benzodiazepines) within the last month
• Women: any selective estrogen receptor modulator or aromatase inhibitor Men: androgen ablation/deprivation hormonal therapies
• Any history of psychosis or electroconvulsive therapy
• Psychotic disorder (lifetime)

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yaakov Stern, Ph.D.

  Sergievsky Center Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

• Richard Sloan, Ph.D.

  Behavioral Medicine Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 18, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

US (1)