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

NCT ID: NCT02726906

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-21
• Study Completion Date: 2022-07-15

Brief 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.

Detailed 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.

Conditions

Aging; Cognitive Ability, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Moderate-aerobic walking

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

Group Type: EXPERIMENTAL

Moderate-aerobic walking

Intervention Type: BEHAVIORAL

Positron Emission Tomography (PET) scan

Intervention Type: RADIATION

Radioligand that binds to proteins using a PET/CT scanner.

Physical activity monitor

Intervention Type: DEVICE

Wrist device that will track daily physical activity

Healthy Living Education

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

Group Type: PLACEBO_COMPARATOR

Positron Emission Tomography (PET) scan

Intervention Type: RADIATION

Radioligand that binds to proteins using a PET/CT scanner.

Healthy living education

Intervention Type: BEHAVIORAL

Physical activity monitor

Intervention Type: DEVICE

Wrist device that will track daily physical activity

Interventions

Moderate-aerobic walking

Intervention Type: BEHAVIORAL

Positron Emission Tomography (PET) scan

Radioligand that binds to proteins using a PET/CT scanner.

Intervention Type: RADIATION

Healthy living education

Intervention Type: BEHAVIORAL

Physical activity monitor

Wrist device that will track daily physical activity

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Judy Pa

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AG046928

Identifier Type: -

Identifier Source: org_study_id