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

University of Southern California

Status: Completed

Conditions: Aging; Cognitive Ability, General

Treatments: Behavioral: Healthy living education; Behavioral: Moderate-aerobic walking; Radiation: Positron Emission Tomography (PET) scan; Device: Physical activity monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02726906

AG046928

Details and patient eligibility

About

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.

Full description

Cognitive decline in older adults is a major public health issue. The cost of caring for older adults with substantial cognitive impairment, like those with Alzheimer's Disease in the US is approximately $200 billion a year, causing major societal, economic, and caregiving burden. Despite great advances towards diagnosing these problems, the discovery of effective treatments has been minimal. Exploring non-pharmacological interventions, such as exercise and healthy living, have gained momentum. These promising, modifiable lifestyle interventions have the potential for delaying disease onset and slowing decline in cognition. However, the therapeutic effect of lifestyle interventions in patients with mild cognitive impairment, a prime intervention period for treatment, is not well understood. Therefore, in this study, the investigators will examine brain, body, and cognitive changes in older adults who engage in moderate-aerobic walking or healthy living education.

Enrollment: 66 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female
2. English-speaking
3. 55-80 years old
4. Exhibits sedentary behavior
5. Objective cognitive impairment
6. Mini-Mental State Exam score > 26
7. Perform at least 1 standard deviations below normative values on cognitive tests
8. Absence of dementia
9. Ability to complete both MRI and PET scans
10. Physically capable of completing health programs

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups, including a placebo group

Moderate-aerobic walking

Experimental group

Description:

Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.

Treatment:

Device: Physical activity monitor

Radiation: Positron Emission Tomography (PET) scan

Behavioral: Moderate-aerobic walking

Healthy Living Education

Placebo Comparator group

Description:

Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.

Treatment:

Device: Physical activity monitor

Radiation: Positron Emission Tomography (PET) scan

Behavioral: Healthy living education