Trial Outcomes & Findings for Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise (NCT NCT03804528)

Last Updated: 2024-09-19

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

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

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	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). Aerobic Exercise in person: 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. Option A: 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).
Overall Study STARTED	75
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	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). Aerobic Exercise in person: 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. Option A: 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).
Overall Study Time Commitment	18
Overall Study Health Reasons	5

Baseline Characteristics

Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Group (All Participants) n=52 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). Aerobic Exercise in person: 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. Two equivalent options provided for participation, to accommodate for COVID-19 pandemic guidelines. 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).
Age, Continuous	62.9 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Black	7 Participants n=5 Participants
Race/Ethnicity, Customized White	24 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	17 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/White	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
BMI Normal (18.5-24.9)	14 Participants n=5 Participants
BMI Overweight (25-29.9)	19 Participants n=5 Participants
BMI Obese Class I (30-34.9)	13 Participants n=5 Participants
BMI Obese Class 2 (35-39.9)	6 Participants n=5 Participants
Education Level High School	9 Participants n=5 Participants
Education Level Undergraduate/Associate Degree	27 Participants n=5 Participants
Education Level Graduate Degree	16 Participants n=5 Participants
Health Status Hospitalized	41 Participants n=5 Participants
Health Status Taking prescribed medication	41 Participants n=5 Participants
Health Status Smoking History	13 Participants n=5 Participants
Health Status Alcohol Consumption	41 Participants n=5 Participants
Health Status Caffeine consumption	49 Participants n=5 Participants
Health Status Hypertension	25 Participants n=5 Participants
Health Status Under beta-blocker	6 Participants n=5 Participants
Health Status Arthritis or joint pain	22 Participants n=5 Participants
Health Status Depression/anxiety	13 Participants n=5 Participants
Health Status Thyroid disease	12 Participants n=5 Participants
Health Status Lung/Asthma disease	11 Participants n=5 Participants
Health Status Tumor or cancer	10 Participants n=5 Participants
Health Status Migraine/Severe headache	9 Participants n=5 Participants
Health Status Heart disease	8 Participants n=5 Participants
Health Status Hearing loss	6 Participants n=5 Participants
Health Status Fainting/Dizzy spells	6 Participants n=5 Participants
Health Status Stomach/Intestinal disease	4 Participants n=5 Participants
Health Status Diabetes	4 Participants n=5 Participants
MoCA - Montreal Cognitive Assessment Global Cognition	26.4 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants

PRIMARY outcome

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

Population: In 2020, due to challenges posed by the COVID-19 pandemic, social distancing practices, and aiming to create a feasible scenario to continue the study, an additional option was added to safely adapt study methods to deliver a home-based, fully remote program given that the duration of the pandemic was unknown at this time point. The study moved forward utilizing these two options, which were not designed as separate study arms but rather designed to be equivalent.

Outcome measures

Outcome measures
Measure	Exercise Group-All Participants n=29 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). Aerobic Exercise in person: 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. Option A: 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).
Change in TMS Plasticity Measures	0.76 minutes Standard Deviation 0.47

PRIMARY outcome

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

Population: Eligibility criteria met. Participants were considered at risk of cognitive decline due to their age, sedentary activity, and other lifestyle factors known to contribute to cognitive decline.

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).

Outcome measures

Outcome measures
Measure	Exercise Group-All Participants n=52 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). Aerobic Exercise in person: 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. Option A: 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).
Cognitive Performance (RBANS) RBANS semantic fluency - Baseline	20.6 mean total correct responses Standard Deviation 5.0
Cognitive Performance (RBANS) RBANS semantic fluency - Post-intervention	20.3 mean total correct responses Standard Deviation 4.3
Cognitive Performance (RBANS) RBANS picture naming - Baseline	9.4 mean total correct responses Standard Deviation 1.0
Cognitive Performance (RBANS) RBANS picture naming - Post-intervention	9.6 mean total correct responses Standard Deviation 0.8
Cognitive Performance (RBANS) RBANS list learning - Baseline	27.0 mean total correct responses Standard Deviation 4.7
Cognitive Performance (RBANS) RBANS list recall - Post-intervention	6.4 mean total correct responses Standard Deviation 2.3
Cognitive Performance (RBANS) RBANS story memory - Baseline	16.4 mean total correct responses Standard Deviation 3.6
Cognitive Performance (RBANS) RBANS story recall - Baseline	8.5 mean total correct responses Standard Deviation 2.5
Cognitive Performance (RBANS) RBANS story recall - Post-intervention	8.9 mean total correct responses Standard Deviation 2.3
Cognitive Performance (RBANS) RBANS list recognition - Baseline	18.6 mean total correct responses Standard Deviation 1.7
Cognitive Performance (RBANS) RBANS digital span - Baseline	10.7 mean total correct responses Standard Deviation 2.2
Cognitive Performance (RBANS) RBANS digital span - Post-intervention	10.8 mean total correct responses Standard Deviation 2.9
Cognitive Performance (RBANS) RBANS figure recall - Baseline	14.1 mean total correct responses Standard Deviation 2.2
Cognitive Performance (RBANS) RBANS figure recall - Post-intervention	14.1 mean total correct responses Standard Deviation 3.0
Cognitive Performance (RBANS) RBANS coding - Baseline	43.8 mean total correct responses Standard Deviation 3.3
Cognitive Performance (RBANS) RBANS coding -Post-intervention	44.0 mean total correct responses Standard Deviation 6.5
Cognitive Performance (RBANS) RBANS figure copy - Baseline	15.8 mean total correct responses Standard Deviation 3.3
Cognitive Performance (RBANS) RBANS figure copy - Post-intervention	16.3 mean total correct responses Standard Deviation 2.8
Cognitive Performance (RBANS) RBANS line orientation - Baseline	17.4 mean total correct responses Standard Deviation 2.4
Cognitive Performance (RBANS) RBANS line orientation - Post-intervention	17.2 mean total correct responses Standard Deviation 3.2
Cognitive Performance (RBANS) RBANS list learning - Post-intervention	28.7 mean total correct responses Standard Deviation 4.7
Cognitive Performance (RBANS) RBANS list recall - Baseline	5.6 mean total correct responses Standard Deviation 2.3
Cognitive Performance (RBANS) RBANS story memory - Post-intervention	17.3 mean total correct responses Standard Deviation 3.5
Cognitive Performance (RBANS) RBANS list recognition - Post-intervention	19.2 mean total correct responses Standard Deviation 1.3

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Exercise Group-All Participants n=52 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). Aerobic Exercise in person: 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. Option A: 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).
Cognitive Performance (DKEFS) DKEFS letter fluency - Baseline	10.9 score on a scale Standard Deviation 3.5
Cognitive Performance (DKEFS) DKEFS letter fluency - Post-intervention	11.4 score on a scale Standard Deviation 3.3
Cognitive Performance (DKEFS) DKEFS category fluency - Baseline	12.4 score on a scale Standard Deviation 2.9
Cognitive Performance (DKEFS) DKEFS category fluency - Post-intervention	11.5 score on a scale Standard Deviation 3.4
Cognitive Performance (DKEFS) DKEFS category switching - Baseline	12.5 score on a scale Standard Deviation 2.8
Cognitive Performance (DKEFS) DKEFS category switching - Post-intervention	12.7 score on a scale Standard Deviation 3.2
Cognitive Performance (DKEFS) DKEFS category switching accuracy - Baseline	12.7 score on a scale Standard Deviation 2.3
Cognitive Performance (DKEFS) DKEFS category switching accuracy - Post-intervention	12.8 score on a scale Standard Deviation 2.9

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Exercise Group-All Participants n=52 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). Aerobic Exercise in person: 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. Option A: 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).
Cognitive Performance (Digital Span) digital span forward - baseline	10.2 scores on a scale Standard Deviation 2.4
Cognitive Performance (Digital Span) digital span forward - Post-intervention	10.4 scores on a scale Standard Deviation 2.3
Cognitive Performance (Digital Span) digital span backward - baseline	8.8 scores on a scale Standard Deviation 2.2
Cognitive Performance (Digital Span) digital span backward - post-intervention	8.3 scores on a scale Standard Deviation 2.4
Cognitive Performance (Digital Span) digital span sequence - baseline	8.7 scores on a scale Standard Deviation 2.2
Cognitive Performance (Digital Span) digital span sequence - post-intervention	8.4 scores on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline

Population: COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued; therefore, blood was not collected for all participants. Blood was only able to be collected for 24 participants at baseline.

Blood samples will be collected to measure: brain-derived neurotrophic factor (BDNF) levels (measured as pg/mL).

Outcome measures

Outcome measures
Measure	Exercise Group-All Participants n=24 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). Aerobic Exercise in person: 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. Option A: 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).
Circulating Markers of Endothelium Function (BDNF)	492.6 pg/mL Standard Deviation 348.1

SECONDARY outcome

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

Population: Participants were considered at risk of cognitive decline due to their age, sedentary activity, and other lifestyle factors known to contribute to cognitive decline.

Heart rate recovery (HRR) is the primary measure for cardiorespiratory fitness. HRR is defined as the change in the heart rate from the peak of exercise to the heart rate after 1-min (HRR-1) and 2-min test cessation (HRR-2).

Outcome measures

Outcome measures
Measure	Exercise Group-All Participants n=52 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). Aerobic Exercise in person: 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. Option A: 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).
Change in Cardiorespiratory Fitness HRR1 - Baseline	23.6 heart beats per minute Standard Deviation 11.6
Change in Cardiorespiratory Fitness HRR1 - Post-intervention	27.0 heart beats per minute Standard Deviation 10.7
Change in Cardiorespiratory Fitness HRR2 - Baseline	33.8 heart beats per minute Standard Deviation 12.5
Change in Cardiorespiratory Fitness HRR2 - Post-intervention	40.4 heart beats per minute Standard Deviation 13.8

SECONDARY outcome

Timeframe: Baseline

Blood samples will be collected to measure vascular endothelial growth factor (VEGF) (measured as pg/mL).

Outcome measures

Outcome measures
Measure	Exercise Group-All Participants n=24 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). Aerobic Exercise in person: 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. Option A: 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).
Circulating Markers of Endothelium Function (VEGF)	12.3 pg/mL Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline

Blood samples will be collected to measure high sensitivity C reactive protein (HS-CRP) (measured as mg/L).

Outcome measures

Outcome measures
Measure	Exercise Group-All Participants n=24 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). Aerobic Exercise in person: 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. Option A: 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).
Circulating Markers of Endothelium Function (Hs-CRP)	1.9 mg/L Standard Deviation 1.3

Adverse Events

Exercise Group (All Participants)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joyce Gomes-Osman

University of Miami

Phone: 305-284-2632

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place