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Cognitive & Physical Interventions for Healthy Aging (SAGE Trial)

N/A

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 65 or older

Have a score within 2 standard deviations (SD) of the age-appropriate mean on the short form of the Boston Naming Test

Must not have

History of Central Nervous System (CNS) diseases or major psychiatric disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria

Medical conditions (e.g., heart or pulmonary disease) that would prevent them from participating in the physical exercise training program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study - 5 weeks post-baseline

Summary

This trial found that structured intervention programs can help improve cognitive processing and performance in older adults. There is evidence that neuroplasticity occurs in individuals over the age of 65.

Who is the study for?

The SAGE trial is for individuals aged 65 or older with good cognitive health, at least 8 years of education, and fluency in English. Participants must score well on tests assessing memory and language skills, have normal vision and hearing, be physically able to engage in exercise, and not suffer from severe depression or major psychiatric disorders.

What is being tested?

This study examines the effects of structured programs like physical activity, cognitive stimulation, mindfulness training versus no intervention (control group) on improving cognitive function in seniors. It also looks for signs of brain changes that suggest learning and adaptation (neuroplasticity).

What are the potential side effects?

Since this trial involves non-invasive interventions such as exercise and mental training rather than medication, side effects are minimal but may include typical exercise-related risks like muscle strain or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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My language skills test score is close to average for my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no history of major brain diseases or serious mental health issues.

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I do not have heart or lung conditions that stop me from doing physical exercises.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study - 5 weeks post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study - 5 weeks post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study - 5 weeks post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions

Categorical Fluency

Controlled Oral Word Association Test (COWAT)

+3 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Physical Exercise Training Using an Interactive Video PlatformActive Control1 Intervention

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.

Group II: Cognitive Training using CogmedActive Control1 Intervention

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

Group III: Awareness (mindfulness) trainingActive Control1 Intervention

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.

Group IV: Low Level of Cognitive Training Using the Cogmed ProgramPlacebo Group1 Intervention

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.

0 / 4Eligibility criteria met