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Cognitive FunctionNCT01179958

Cognitive Benefits of Aerobic Exercise Across the Age Span

A study testing aerobic training and stretching/toning in people with Cognitive Function, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the hypothesis that aerobic exercise leads 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 20 to 68 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Function
What is being tested?
aerobic training and stretching/toning
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
1 siteUnited States
Study dates
Aug 2010to 29 Jun 2016
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 20 to 68 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 20-68
  • English-speaking
  • strongly right-handed
  • BMI < 35
  • Pre-menopausal (women only): no oral contraceptive use Post-menopausal: no estrogen replacement therapy
  • sedentary: VO2 max < 41 and 31.6 ml/kg/min for men age 20-40 and 50-68 and < 35.2 and 26.6 ml/kg/min for women age 20-40 and 50-68 respectively
  • participants over age 60 must have ECG within past 3 months

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 ≥ 140 mmHg; or diastolic blood pressure ≥ 90 mmHg on two measures)
Show all 20Show 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
  • Medications that target CNS (central nervous system, 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
  • Current or recent (Past 5 years) Major Depressive Disorder, Bipolar Disorder, or Anxiety Disorder
  • Dementia Rating Scale < 135

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Richard Sloan

    New York, New York, 10013

Other trials in United States

About this study

The purpose of this study is to test the hypothesis that aerobic exercise leads 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

While animal and human studies indicate cognitive benefits from aerobic exercise across the lifespan, the great majority of controlled exercise studies in humans have been restricted to elderly individuals. Those studies have indicated that enhancing aerobic capacity has a beneficial effect on cognition. One study suggests that this benefit is seen particularly for executive control processes, precisely the processes affected by aging. These improvements have been accompanied by increases in gray matter density and changes in functional magnetic resonance imaging (fMRI) patterns of task-related activation. The goal of the proposed study is to extend the investigation of the beneficial effects of aerobic exercise to younger individuals, and to compare these effects in young and old.

In this application the study team propose to conduct a study in which 270 sedentary but otherwise healthy and cognitively intact individuals in the 20-68 year age range are randomized to two training conditions, aerobic exercise and stretching/toning, to be completed at YMCAs and YMHAs in New York City. Participants will be assessed for aerobic capacity, cognitive task performance, and by structural MRI, resting cerebral blood flow scans (arterial spin labeling) and cognitive activation fMRI studies at study entry and after 6 months of training.

The study also proposes two complementary approaches to investigating the neural correlates of the beneficial effects of aerobic exercise on cognition: 1) imaging -- a combination of structural, metabolic, and cognitive activation fMRI studies to evaluate the neural substrates of the effect of aerobic exercise on cognition will be used. 2) important correlates -- the effects of apolipoprotein E (APOE) genotype, inflammatory markers and cognitive reserve on the cognitive effects of aerobic exercise will be explored.

Being tested
aerobic training, stretching/toning
Keywords
cognitive function, fMRI, apoE, inflammatory markers, exercise
Medical subject headings
Motor Activity

What participants receive

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

  • aerobic trainingBehavioural

    Also called Training, aerobic

    24 weeks of aerobic training, 4X/week

  • stretching/toningBehavioural

    Also called Exercises, stretches and toning

    stretches and toning exercises designed to promote flexibility and improved core strength

Study groups in NCT01179958
Study groupRoleWhat they receive
aerobic trainingExperimental24 weeks of aerobic training, 4 times/week
Receives: Behavioral: aerobic training
stretching/toningPlacebo comparatorstretching/toning condition, 24 weeks to parallel the active intervention group
Receives: Behavioral: stretching/toning

What is being measured

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

  1. Change from baseline in measures of executive control function and episodic memory at 6 months

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

    Measured: 24 weeks

Secondary outcomes (4)

  1. Change from baseline in brain structure, resting cerebral blood flow and network efficiency at 6 months

    structural MRI (for gray matter density), resting CBF (cerebral blood flow, measured by arterial spin labeling) and cognitive activation fMRI studies

    Measured: 24 weeks

  2. Change from baseline in measures of interleukin-6, tumor necrosis factor alpha, C-reactive protein at 6 months

    Measured: Baseline and 24 weeks

  3. Change from baseline in aerobic capacity at 6 months

    aerobic capacity as measured by VO2 max

    Measured: 24 weeks

  4. Change from baseline in measures of executive control function and episodic memory at 1 year

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

    Measured: 48 weeks

Timeline

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

  1. First posted11 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2016
  4. Study completion29 Jun 2016

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
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01179958
Sponsor's protocol ID
#6211/7140R
Other IDs
AG030092
Status last verified
Aug 2018
First submitted
10 Aug 2010
Last updated
17 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Predovan D, Gazes Y, Lee S, Li P, Sloan RP, Stern Y. Effect of Aerobic Exercise on White Matter Tract Microstructure in Young and Middle-Aged Healthy Adults. Front Hum Neurosci. 2021 Jul 2;15:681634. doi: 10.3389/fnhum.2021.681634. eCollection 2021.

    PubMed 34276329

  • Stern Y, MacKay-Brandt A, Lee S, McKinley P, McIntyre K, Razlighi Q, Agarunov E, Bartels M, Sloan RP. Effect of aerobic exercise on cognition in younger adults: A randomized clinical trial. Neurology. 2019 Feb 26;92(9):e905-e916. doi: 10.1212/WNL.0000000000007003. Epub 2019 Jan 30.

    PubMed 30700591

Questions about this trial

What is this clinical trial studying?

A study testing aerobic training and stretching/toning in people with Cognitive Function, run by New York State Psychiatric Institute 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 7 inclusion and 20 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: finished, as of the sponsor's last update on 17 Aug 2018. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in measures of executive control function and episodic memory at 6 months (time frame: 24 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 NCT01179958, which also lists 2 linked publications.

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 17 Aug 2018.

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