Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise

NCT ID: NCT03804528

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-08
• Study Completion Date: 2021-05-28

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).

Conditions

Sedentary Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise group (All participants)

Each participant will engage in 60 minute in-person daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions). Participants were provided with option to participate remotely due to COVID-19 pandemic.

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session. Participants are provided the option to participate remotely due to COVID-19 pandemic, as detailed below. Both options are designed to be equivalent in intervention and outcome measures.

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).

Interventions

Aerobic Exercise

Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session. Participants are provided the option to participate remotely due to COVID-19 pandemic, as detailed below. Both options are designed to be equivalent in intervention and outcome measures.

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joyce R Gomes-Osman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Miller School of Medicine

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34817393 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

KL2TR002737

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20180926

Identifier Type: -

Identifier Source: org_study_id