Cognitive Benefits of Aerobic Exercise Across the Age Span
2 other identifiers
interventional
305
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2016
CompletedAugust 17, 2018
August 1, 2018
5.8 years
August 10, 2010
August 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
24 weeks
Secondary Outcomes (4)
Change from baseline in brain structure, resting cerebral blood flow and network efficiency at 6 months
24 weeks
Change from baseline in measures of interleukin-6, tumor necrosis factor alpha, C-reactive protein at 6 months
Baseline and 24 weeks
Change from baseline in aerobic capacity at 6 months
24 weeks
Change from baseline in measures of executive control function and episodic memory at 1 year
48 weeks
Study Arms (2)
aerobic training
EXPERIMENTAL24 weeks of aerobic training, 4 times/week
stretching/toning
PLACEBO COMPARATORstretching/toning condition, 24 weeks to parallel the active intervention group
Interventions
24 weeks of aerobic training, 4X/week
stretches and toning exercises designed to promote flexibility and improved core strength
Eligibility Criteria
You may qualify if:
- 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
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 ≥ 140 mmHg; or diastolic blood pressure ≥ 90 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
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Richard Sloan
New York, New York, 10013, United States
Related Publications (2)
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.
PMID: 34276329DERIVEDStern 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.
PMID: 30700591DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard P Sloan, PhD
Columbia University
- PRINCIPAL INVESTIGATOR
Yaakov Stern, PhD
Columbia University
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
- Division Chief
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 11, 2010
Study Start
August 1, 2010
Primary Completion
May 1, 2016
Study Completion
June 29, 2016
Last Updated
August 17, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share