Efficacy and mechanisms of device-monitored aerobic exercise for depression treatment and cognitive function improvement (DAECD trail): protocol for a randomized controlled trial
Randomized trial outlines device-monitored aerobic exercise for depression and cognitive impairment, indicating potential mechanisms for individualized therapy.
Key Points
This protocol evaluates the clinical efficacy and biological mechanisms of an eight-week, device-monitored aerobic exercise program for depression and cognitive impairment.
Randomized controlled trial (NCT06594588) assigning 80 patients with depression (1:1) to either an 8-week aerobic exercise regimen (30–50 min moderate-intensity sessions, 3 times per week alongside routine care) or a waitlist control group.
Primary efficacy is measured using changes in Hamilton Depression Rating Scale scores from baseline to week 8, analyzed under the intention-to-treat principle via mixed-effects models.
Mechanisms are investigated via pre- and post-intervention neuroimaging, laboratory evaluations, and multi-omics profiling.
Protocol design targets significant reduction in Hamilton Depression Rating Scale scores as the primary endpoint at week 8 compared to waitlist control.
Secondary outcomes assess alterations in cognitive performance, anxiety symptoms, sleep parameters, resilience, physical capacity, and biological marker shifts.
Mechanistic endpoints aim to isolate neuroimaging and multi-omic markers that differentiate responsive subgroups to enable personalized exercise prescriptions.