Clinical trial NCT03804528: Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise
Official title: Assessing Cognitive Improvements, Brain Neuroplasticity and the Role of Genetic Factors After Aerobic Exercise in Sedentary Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-01-15
Enrollment: 75
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overall goal of the proposed study is to evaluate the effects of an 8-week aerobic exercise program on cognition and determine the relationship between cognitive improvements and Transcranial Magnetic Stimulation (TMS) neuroplasticity.

Detailed description: The overall goal of the proposed study is to evaluate the effects of an 8-week aerobic exercise program on cognition and determine the relationship between cognitive improvements and neuroplasticity. The primary study aims include: 1) Quantify improvements in cognitive performance after 8 weeks (150 min per week) of moderate intensity aerobic exercise in sedentary adults ≥ 55 years of age; 2) Determine an association between changes in plasticity, aerobic capacity, and cognitive performance overall and by cognitive domain, after 8 weeks of moderate intensity aerobic exercise in sedentary adults ≥ 55 years of age.

Due to challenges posed by the COVID-19 pandemic, social distancing practices, and aiming to create a feasible scenario to continue the current study, we propose an additional option to safely adapt study methods to deliver the study in a home-based, fully remote manner. Importantly, this scenario also presents as an opportunity to collect meaningful data on our specific aims while translating this successful research program into a remote/home-based mode of delivery. A remote/home based option may also yield valuable preliminary data that will be relevant for planning future exercise studies in aging adults in the present "new normal". Therefore, this research project consist of two equivalent options:

Option A: Current, IRB-approved, in-person methods pending appropriateness based on current University of Miami recommendations and standard operating procedures as it relates to the COVID-19 pandemic.

Option B: Remote option of current methods to maximize recruitment. This will be the only option until the study team obtains approval to resume Option A (as per University's safety guidelines).

Eligibility criteria: Inclusion Criteria:

* age ≥ 55years
* no clinically detectable cognitive impairment (MoCA score ≥ 24 and Clinical Dementia Rating (CDR) score of 0)
* low activity level (individuals who do not engage in regular exercise, or currently exercise once a week or less)
* primary language is English

Exclusion Criteria:

* any unstable medical condition (i.e.: uncontrolled hypertension or uncontrolled diabetes)
* medical contraindication to physical exercise
* contraindication to TMS Neuroplasticity testing, as per the TMS Safety Guidelines.
* History of fainting spells of unknown or undetermined etiology that might constitute seizures
* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistant epilepsy
* Any current history of a psychiatric illness
* No medication is an absolute exclusion from TMS. Medications will be reviewed by the Principal Investigator and a decision about inclusion will be made based on the following:
* The subject's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other Central Nervous System (CNS) active drugs.
* The published TMS guidelines review medications to be considered with TMS.
* Any metal in the brain, skull or elsewhere unless approved by the responsible MD
* Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator)
* Intracranial lesion
* Substance abuse or dependence within the past six months
* Pregnant women
* Vulnerable populations such as prisoner's
* People unable to consent themselves
* Subjects who, in the Investigator's opinion might not be suitable for the study

Primary outcomes:
measure: Change in TMS Plasticity Measures
timeFrame: Baseline and Post-intervention (after 8 weeks of exercise)
measure: Cognitive Performance (RBANS)
timeFrame: Baseline and Post-intervention (after 8 weeks of exercise)
measure: Cognitive Performance (DKEFS)
timeFrame: Baseline and Post-intervention (after 8 weeks of exercise)
measure: Cognitive Performance (Digital Span)
timeFrame: Baseline and Post-intervention (after 8 weeks of exercise)
Secondary outcomes:
measure: Circulating Markers of Endothelium Function (BDNF)
timeFrame: Baseline
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline and Post-intervention (after 8 weeks of exercise)
measure: Circulating Markers of Endothelium Function (VEGF)
timeFrame: Baseline
measure: Circulating Markers of Endothelium Function (Hs-CRP)
timeFrame: Baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Joyce R Gomes-Osman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabral DF, Hinchman CA, Nunez C, Rice J, Loewenstein DA, Cahalin LP, Rundek T, Pascual-Leone A, Gomes-Osman J. Harnessing Neuroplasticity to Promote Brain Health in Aging Adults: Protocol for the MOVE-Cog Intervention Study. JMIR Res Protoc. 2021 Nov 23;10(11):e33589. doi: 10.2196/33589.