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Cognitive FunctionNCT01183819

Cognitive Control and Physical Exercise

A study testing Space Fortress, Aerobic Exercise and Stretching in people with Cognitive Function and Day-to-Day Function, run by Columbia University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Function, Day-to-Day Function
What is being tested?
Space Fortress, Aerobic Exercise and Stretching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Feb 2010to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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))

Who cannot join

  • 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)
Show all 19Show fewer
  • 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)
  • Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
  • Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury, mental retardation
  • 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
  • Diagnosed learning disability, dyslexia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: Cognitive Control and Physical Exercise: A Multi-Modal Intervention

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.

Read the 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.

Being tested
Space Fortress, Aerobic Exercise, Stretching, Control Games
Keywords
cognitive function, fMRI, apoE, inflammatory markers, exercise, cognitive intervention, Space Fortress
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Space FortressBehavioural

    Space Fortress sessions 3 times a week for 12 weeks

  • Aerobic ExerciseBehavioural

    Aerobic Exercise 4 times a week for 12 weeks

  • StretchingBehavioural

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

  • Control GamesBehavioural

    Control games session 3 times a week for 12 weeks

Study groups in NCT01183819
Study groupRoleWhat they receive
Space Fortress and ExerciseExperimentalParticipants engage in aerobic exercise 4 times week and Space Fortress sessions 3 times a week for a total of 12 weeks.
Receives: Behavioral: Space Fortress; Behavioral: Aerobic Exercise
Control Games and ExerciseActive comparatorParticipants engage in aerobic exercise 4 times a week and control game sessions 3 times a week for a total of 12 weeks.
Receives: Behavioral: Aerobic Exercise; Behavioral: Control Games
Control Games and StretchingActive comparatorParticipants engage in stretching/toning exercises 4 times a week and control game sessions 3 times a week for a total of 12 weeks.
Receives: Behavioral: Stretching; Behavioral: Control Games

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 12 weeks

Secondary outcomes (3)

  1. 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

    Measured: Baseline and 12 weeks

  2. Change in aerobic capacity at 6 months

    aerobic capacity as measured by VO2 max

    Measured: Baseline and 12 weeks

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

    tests of global intelligence, executive function, working memory and processing speed

    Measured: Baseline and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: insufficient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01183819
Sponsor's protocol ID
AAAE5848
Other IDs
R01AG034178
Status last verified
Aug 2015
First submitted
16 Aug 2010
Last updated
5 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Space Fortress, Aerobic Exercise and Stretching in people with Cognitive Function and Day-to-Day Function, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in measures of executive control function and episodic memory at 6 months (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01183819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.

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