N/A N=66 Randomized Single-blind Treatment

Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study

Aging · Cognitive Ability, General

Bottom Line

View on ClinicalTrials.gov: NCT02726906 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Sep 2024

Primary outcome: Primary: Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function — -0.442; -0.203; 0.018; 0.033 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Moderate-aerobic walking (Behavioral); Positron Emission Tomography (PET) scan (Radiation); Healthy living education (Behavioral); Physical activity monitor (Device)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: University of Southern California
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function	-0.442; -0.203; 0.018; 0.033	—
PRIMARY Mnemonic Similarity Test as a Measure of Memory (Cognition)	0.32; 0.32; 0.28; 0.36	—
SECONDARY Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)	1.05; 1.01; 1.05; 1.01	—
SECONDARY Single-stage Treadmill Test	29.5; 30.0; 31.2; 31.1	—
SECONDARY Modified Physical Function Test	33.1; 33.0; 33.6; 33.7	—
SECONDARY Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood	5.80; 8.11; 6.15; 6.63	—

Summary

The purpose of this study is to examine the effects of modifiable lifestyle factors including exercise and healthy living on brain health. The investigators will compare 2 types of interventions, moderate aerobic walking vs. healthy living education, over 6 months to evaluate changes in brain health, cognition, and physical function in older adults with cognitive concerns.

Eligibility Criteria

Inclusion Criteria

Male or female
English-speaking
55-80 years old
Exhibits sedentary behavior
Objective cognitive impairment
Mini-Mental State Exam score > 26
Perform at least 1 standard deviations below normative values on cognitive tests
Absence of dementia
Ability to complete both MRI and PET scans
Physically capable of completing health programs

Exclusion Criteria

Baseline dementia
History of a neurological disorder
Current psychiatric illness
Head trauma with a loss of consciousness > 10 minutes
Severe sensory deficits
Substance abuse
Depression (GDS < 8 of 15)
Inability to perform intervention (e.g., inability to walk without assistance)
Contraindications to MRI scan (e.g., pacemaker)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02726906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.