Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise

NCT03804528 | Terminated Results

• 2 other identifiers: 20180926KL2TR002737
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior

Outcome Measures

Primary Outcomes (4)

• Change in TMS Plasticity Measures

  Index of the duration of the Theta-burst stimulation (TBS)-induced modulation of corticospinal excitability. This outcome measure refers to the identification of the time point (T5, T10, T15, T20 and T30). at which the normalized motor evoked potential (MEP) amplitude returns to baseline values (T0 or Baseline). This measure will be in Minutes Post Theta-Burst stimulation. This is a neurophysiological measure, and no group-based norms apply.

  Baseline and Post-intervention (after 8 weeks of exercise)

• Cognitive Performance (RBANS)

  Cognitive performance will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) a neuropsychological test battery in executive function, processing speed, learning, and language. It is made up of a series of twelve subtests that take approximately 30 minutes. For each of these, a lower number correct is indicative of a higher cognitive deficit. Subtests are their scales are: RBANS Semantic Fluency (0-unlimited), RBANS Picture Naming (0-10), RBANS List Learning (0-40), RBANS List Recall (0-10), RBANS Story Memory (0-24), RBANS Story Recall (0-12), RBANS List Recognition (0-20), RBANS Digit Span (0-16), RBANS Figure Recall (0-20), RBANS Coding (0-89), RBANS Figure Copy (0-20), RBANS Line Orientation (0-20).

  Baseline and Post-intervention (after 8 weeks of exercise)

• Cognitive Performance (DKEFS)

  Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language. The D-KEFS Verbal Fluency Test measures the ability to generate words fluently in an effortful phonemic format (letter fluency),from overlearned concepts (category fluency), and simultaneously shifting between overlearned concepts (category switching). Raw scores (correct responses, correct number of switches between categories) are converted to scaled scores with a mean of 10 and a standard deviation of 3. Higher scores reflect higher verbal fluency, and an increase in score pre-post would indicate improvement.

  Baseline and Post-intervention (after 8 weeks of exercise)

• Cognitive Performance (Digital Span)

  Digital span - Subtest of the Wechsler Adult Intelligence Scale fourth edition; Three sections: Digits Forward, Digits Backward, and Digits Sequencing. For each section, min. raw score value: 0; max. raw score value: 16. Higher the score, better the outcome.

  Baseline and Post-intervention (after 8 weeks of exercise)

Secondary Outcomes (4)

• Circulating Markers of Endothelium Function (BDNF)

  Baseline

• Change in Cardiorespiratory Fitness

  Baseline and Post-intervention (after 8 weeks of exercise)

• Circulating Markers of Endothelium Function (VEGF)

  Baseline

• Circulating Markers of Endothelium Function (Hs-CRP)

  Baseline

Study Arms (1)

Exercise group (All participants)

EXPERIMENTAL

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.

Behavioral: Aerobic Exercise

Interventions

Aerobic Exercise 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).

Exercise group (All participants)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Miami: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 34817393 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The COVID-19 pandemic and resulting changes to remote clinical research modalities impacted the implementation of the study. Although the study was modified to accommodate remote participation, this modality prohibited the collection of clinical measures that required physical presence, such as TMS and blood collection, and required the adjustment for other measures, such as cardiorespiratory fitness assessment.

Results Point of Contact

• Title: Joyce Gomes-Osman
• Organization: University of Miami

j.gomes@miami.edu

305-284-2632

Study Officials

• Joyce R Gomes-Osman, PT, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: January 15, 2019
• Study Start: March 8, 2019
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)