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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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