AMPLIFI: Adaptive Modulation of Plasticity Through Lactate and Fitness Interventions
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT06950060
- Status
- Not Yet Recruiting
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Conditions
- Aging
- Cognitive Decline
- Motor Dysfunction
- Neuroplasticity
- Stroke, Chronic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Accepted
Interventions
- High intensity cycling — BEHAVIORALParticipants 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 — BEHAVIORALParticipants 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 — BEHAVIORALParticipants 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 — BEHAVIORALParticipants 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.
Study Details
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.
Key Dates
- Start date
- May 14, 2026
- Status verified
- Apr 2026
- Primary completion
- Sep 1, 2029
- Completion
- Jan 1, 2030
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Aerobic Exercise at Lactate ThresholdParticipants complete a 20-minute aerobic cycling session at individually prescribed intensity to achieve lactate threshold, based on VO2 max and blood lactate data. This condition is designed to induce metabolic stress and engage neuromodulatory pathways related to cortical plasticity. Participants complete TMS and motor learning tasks before and after the intervention.
- Active Comparator: Low-Intensity Aerobic ExerciseParticipants complete a 20-minute cycling session at a light workload, below lactate threshold. This condition controls for movement and engagement without significant metabolic challenge. TMS and motor learning outcomes are assessed pre- and post-intervention.
- Placebo Comparator: Education ControlParticipants engage in a 20-minute health education session instead of exercise. This arm serves as a non-exercise control to isolate the effects of physical exertion on neuroplasticity. All outcome measures are collected similarly to the exercise groups.
- Active Comparator: Active Comparator: Moderate-Intensity Aerobic ExerciseArm Description: Participants complete a 20-minute cycling session at a moderate workload, surrounding lactate threshold. This condition controls for movement and engagement without advanced metabolic challenge. TMS and motor learning outcomes are assessed pre- and post-intervention.
Primary Outcome Measure
Motor Learning Performance (12-Digit Serial Reaction Time Task) [ Time Frame: Baseline, Day 2, Day 3, Day 4, and Day 5 ]
Central Contacts
- Keith M McGregor, PhD(205) 693-9997
- Ayat Najmi, BS2059346030
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| CH19 933 19th St S | Birmingham | Alabama | 35233 | Keith M McGregor, PhD (PRINCIPAL_INVESTIGATOR) |
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