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

Not Applicable

Completed

• Conditions: Aging; Cognitive Ability, General
• Interventions: Behavioral: Moderate-aerobic walking; Radiation: Positron Emission Tomography (PET) scan; Behavioral: Healthy living education; Device: Physical activity monitor

• Registration Number: NCT02726906
• Lead Sponsor: University of Southern California

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-04
• Study Start: 2016-08-21
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-15
• Disposition First Submitted: 2023-07-11
• Disposition First Posted: 2024-01-18
• Results First Submitted: 2024-06-24
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-18
• Results First Posted: 2024-09-19
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate-aerobic walking	Positron Emission Tomography (PET) scan	Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Moderate-aerobic walking	Physical activity monitor	Participants will complete a 6-month home-based moderate-aerobic walking program of 150 minutes per week with the assistance of an interventionist.
Healthy Living Education	Physical activity monitor	Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Moderate-aerobic walking	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.
Healthy Living Education	Positron Emission Tomography (PET) scan	Participants will receive monthly topics on healthy living lifestyles for self-paced reading over 6 months with the assistance of an interventionist.
Healthy Living Education	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.

Primary Outcome Measures

Name	Time	Method
Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function	Baseline and Follow-up at 6 months	Functional MRI has proven to be an effective non-invasive, in-vivo tool for measuring brain function via the BOLD signal. Growing evidence supports that fMRI BOLD can detect neuronal changes that occur very early in the disease process. The hippocampus has been shown to be a selectively vulnerable region in AD, and several studies, including our own, identified a aberrant brain signal in the hippocampus in older adults. The typical range for this outcome is -10 to 10 with higher scores indicating better brain function.
Mnemonic Similarity Test as a Measure of Memory (Cognition)	Baseline and Follow-up at 6 months	The participants will encode a series of objects presented on a computer. Following the encoding period, they will begin their fMRI scan and be asked to indicate if they recognize the objects on the screen, which include targets (previously seen objects), lures (objects that are similar to previously seen objects) and novel (unrelated objects). The discrimination between Targets and Lures will indicate the rate at which participants "correctly reject" the Lures (via pattern separation) or "false alarm" to the Lures (via pattern completion). The theoretical range for this outcome is -1 to 1 with higher scores indicating better memory function.

Secondary Outcome Measures

Name	Time	Method
Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)	Baseline and Follow-up at 6 months	Each participant received PET scans with Neuraceq \[florbetaben F 18 (FBB)\] to measure amyloid-beta PET binding. IV injections of the tracers (FBB, -8.11 6 0.6 mCi) were done outside of the scanning room. Four 5-min frames were acquired 90 minutes after injection.
Single-stage Treadmill Test	Baseline and Follow-up at 6 months	This is a measure of cardiovascular fitness. This test has been validated against peak VO2 max with r=0.96. Heart rate response is monitored with a Polar heart rate monitor and the heart rate at the end of the 4 min test is used to estimate VO2max using an established equation for conversion. The theoretical range for this outcome is 0 to 200 with higher scores indicating better cardiovascular fitness.
Modified Physical Function Test	Baseline and Follow-up at 6 months	This test is a measure of multiple domains related to functional activities of daily living. Each physical activity in score is of varying difficulty level. The theoretical range for this outcome is 0 to 36 with higher scores indicating better physical function.
Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood	Baseline and Follow-up at 6 months	We will quantitatively analyze pre- and post-measurements of brain derived neurotrophic factor (BDNF). BDNF has been shown to increase after exercise intervention in humans and peripheral increases in these hormones correlate to cell proliferation in the dentate gyrus of the hippocampus. We measure total BDNF from plasma.

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States