Successful Aging and Enrichment (SAGE)

Mass General Brigham

Status: Active, not recruiting

Conditions: Healthy Aging; Cognitive Health

Treatments: Behavioral: Mindfulness training; Behavioral: Physical Activity; Behavioral: Control Group; Behavioral: Cognitive Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05128396

2013P002266

Details and patient eligibility

About

Progress has been made in understanding the impact of different kinds of structured intervention programs in improving cognitive processing and performance in older adults, and in determining whether there is electrophysiological evidence for neuroplasticity in individuals over the age of 65.

Full description

Study Procedures

Pre-Intervention Assessment The initial screening evaluation will take place over two half-day sessions, each lasting 3 to 3.5 hours in a designated room in the Laboratory of Healthy Cognitive Aging, Center for Brain/Mind Medicine, Brigham and Women's Hospital (BWH), 221 Longwood Avenue, Boston, Massachusetts (MA).

The sessions can be completed over one or two days, depending on the subject's preference.

Pre-Intervention Assessment Session 1 The first session will include completion of informed consent, a medical history, demographic information, including socioeconomic status (SES), survey questionnaires, and tests of visual acuity.

Screening Evaluation (for inclusion/exclusion)

Cognitive Screen

• The Mini-Mental State Examination (MMSE), a broad cognitive test on memory, spatial ability, memory and orientation, commonly used to screen for cognitive impairment
• American National Adult Reading Test (AmNART), a test of word pronunciation that provides an estimated IQ
• Logical Memory I and II, Wechsler Memory Scale-Third Edition, a test of verbal memory
• Boston Naming Test (Short-form, 15-items), a test of confrontation naming.

Depression Screen Geriatric Depression Scale

Neurological/Physical Evaluation Subjects will undergo a structured neurological examination. Height and weight will be obtained to calculate BMI. Visual acuity will be measured (Snellen wall chart).

Gait

Gait will be assessed through a procedure in which subjects walk 10 meters under two conditions:

1. Single task (walking at a comfortable pace)
2. Dual task (walking at a comfortable pace while simultaneously counting backwards by 3's, beginning with a 3 digit number told to the subject)

Every trial involving serial 3's will start from a different three digit number to reduce learning effects.

Subjects will be given an opportunity to carry out an untimed practice trial. Under the dual task condition, subjects will be instructed to perform as well as possible on both tasks (i.e., no specified prioritization). Each condition will be done 2 times, with the order counterbalanced across subjects. The first and last meter (gait start up and slow down) will not be counted in the measurements.

Time to walk 8 meters and number of steps taken will be measured. Under the dual task, investigators will also track how many numbers are generated while carrying out the serial 3's task (both correct and incorrect responses). In addition, the single task of counting backwards by 3's for 20 seconds will be tested twice in a seated position (once prior to and once after the gait testing).

Informant Questionnaire Subjects will select someone who knows them well (family member or friend) to complete a set of questionnaires. One questionnaire will provide information about a person's level of functioning (based on the Clinical Dementia Rating Scale), and another will inquire about a person's level of engagement (Apathy Scale). e questionnaires will be enclosed with a letter explaining how to complete the forms. The investigators will provide a stamped, addressed envelope to return the questionnaires to us. A backup plan will be to mail these materials directly to the informant selected. This would occur if the materials were misplaced or if the subject requests us to do so.

Enrollment: 72 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Be 65 or older
2. Have ≥ 8 years of education
3. Be sufficiently fluent in the English language to understand instructions and perform the neuropsychological tests (as the purpose of the project is to study healthy aging)
4. Score above levels indicating possible cognitive impairment on the Mini Mental State Exam (MMSE) (≥ 26)
5. Have an estimated intelligence quotient (IQ) score ≥ 90 based on the American National Reading Test (AmNART)
6. Have a score within 2 standard deviations (SD) of the age-appropriate mean on the short form of the Boston Naming Test
7. Have a score within 2 SD of the age-appropriate mean on the Logical Memory Subtest of the Wechsler Memory Scale-Third Edition

Exclusion criteria

1. History of Central Nervous System (CNS) diseases or major psychiatric disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
2. Score of greater than 10 on the Geriatric Depression Scale
3. Corrected visual acuity worse than 20-50 as tested by a Snellen wall chart
4. Severe hearing disability that would interfere with their ability to participate in the experiments (e.g., to hear instructions and participate in cognitive testing)
5. Medical conditions (e.g., heart or pulmonary disease) that would prevent them from participating in the physical exercise training program
6. Evidence of substantial functional decline based on interview questions and completion of a questionnaire based on the Clinical Dementia Rating Scale by an informant who knows the subject well

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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72 participants in 4 patient groups, including a placebo group

Cognitive Training using Cogmed

Active Comparator group

Description:

Subjects will complete computerized cognitive training with varying degrees of difficulty over 5 weeks.

Treatment:

Behavioral: Cognitive Stimulation

Awareness (mindfulness) training

Active Comparator group

Description:

Subject participate in mindfulness training. The meditation and tasks will become increasingly more self-directed over the 5 weeks; the degree of guidance will decrease to keep the subjective effort approximately constant and moderately challenging through the 5 weeks.

Treatment:

Behavioral: Mindfulness training

Physical Exercise Training Using an Interactive Video Platform

Active Comparator group

Description:

Subjects will participate in a structured physical exercise training program that aims to progressively increase their level of activity over the 5 week training period.

Treatment:

Behavioral: Physical Activity

Low Level of Cognitive Training Using the Cogmed Program

Placebo Comparator group

Description:

Subjects will complete the same computerized training as the active cognitive arm over the course of 5 weeks, but the main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time.

Treatment:

Behavioral: Control Group