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AMPLIFI: Adaptive Modulation of Plasticity Through Lactate and Fitness Interventions

ConditionsStroke, ChronicAgingCognitive DeclineMotor DysfunctionNeuroplasticity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham

About this trial

The AMPLIFI study (Adaptive Modulation of Plasticity through Lactate and Fitness Interventions) investigates how short-term aerobic exercise influences brain plasticity and learning in older adults and stroke survivors. The study compares three groups: one performing aerobic cycling at an intensity that elevates lactate levels, one performing low-intensity exercise, and one receiving health education without exercise.

All participants will complete motor learning tasks and undergo brain-stimulation testing using transcranial magnetic stimulation (TMS) to assess how well the brain responds to training. The goal is to understand whether different types of exercise can improve brain function, movement, and memory, and how the body's response to exercise (like lactate levels) might support brain health.

This research may help identify low-cost, non-invasive interventions-such as targeted exercise-that improve motor and cognitive outcomes in aging and stroke recovery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to provide informed consent

Right-handed (for TMS consistency)

English-speaking

Clearance for moderate-intensity aerobic exercise

Disqualifiers

History of epilepsy or seizures

Current substance abuse or uncontrolled psychiatric disorder

Severe cardiovascular disease or unstable medical condition

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • High intensity cycling

    Behavioral

    Participants cycle on a stationary ergometer at an intensity prescribed to reach their lactate threshold, guided by VO2 max results and lactate sampling. The session lasts approximately 20 minutes and is preceded and followed by TMS assessments and a structured motor learning task. This condition is designed to evaluate the effect of exercise-induced metabolic stress on cortical inhibition and motor learning.

  • Low-intensity cycling

    Behavioral

    Participants perform 20 minutes of cycling at a light workload below their lactate threshold. Exercise intensity is individualized using heart rate and perceived exertion (Borg RPE scale), avoiding significant metabolic activation. TMS and motor learning are assessed pre- and post-exercise. This condition serves as an active comparator to assess the impact of exercise intensity.

  • Health education session

    Behavioral

    Participants receive a 20-minute session of health education content (e.g., wellness, healthy aging). No exercise is performed. Participants undergo TMS and motor learning testing before and after the session. This condition is used to control for attention and cognitive engagement without physical activity.

  • Moderate Intensity Aerobic Exercise

    Behavioral

    Participants cycle on a stationary ergometer at an intensity prescribed to surround, but not exceed their lactate threshold, guided by VO2 max results and lactate sampling. The session lasts approximately 20 minutes and is preceded and followed by TMS assessments and a structured motor learning task. This condition is designed to evaluate the effect of moderate exercise-induced metabolic stress on cortical inhibition and motor learning.

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Aerobic Exercise at Lactate ThresholdExperimental treatment 1 intervention
Group B: Low-Intensity Aerobic ExerciseActive comparator 1 intervention
Group C: Education ControlPlacebo comparator 1 intervention
Group D: Active Comparator: Moderate-Intensity Aerobic ExerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Motor Learning Performance (12-Digit Serial Reaction Time Task)

Motor learning is assessed using the 12-digit Serial Reaction Time Task (SRTT), a computer-based measure of implicit motor sequence learning. Participants respond to visual cues by pressing buttons in a fixed or random sequence. Learning is quantified by changes in reaction time and accuracy across structured and unstructured trials. A learning index is derived by comparing performance between patterned (learning) and random sequences.

Time frame
Baseline, Day 2, Day 3, Day 4, and Day 5

Secondary outcomes

1

Change in Long-Interval Intracortical Inhibition (LICI)

LICI is measured using a 100 ms interstimulus interval to assess GABA\<sub\>B\</sub\>-mediated inhibition. Recorded before and after each intervention session.

Time frame
Baseline, Day 5
2

Change in Intracortical Facilitation (ICF)

ICF is assessed using paired-pulse TMS with a 10-15 ms interstimulus interval to evaluate cortical excitability.

Time frame
Baseline, Day 5
3

Change in Blood Lactate Concentration

Measured via fingerstick blood samples pre-, mid-, and post-exercise.

Time frame
Day 2, Day 3, Day 4
4

Change in Executive Function (D-KEFS Verbal Fluency and Stroop Tests)

Executive function neuropsychological tests.

Time frame
Day 1 and Day 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

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