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Breathing, Relaxation, Attention Training, & Health in Older Adults (BREATHE)
Recruiting
Trial ID: NCT04522791
Purpose
A recently completed study suggested that processing speed and attention (PS/A) oriented
cognitive training (VSOP) produced robust effect on PS/A and working memory, but not in
cognitive control or episodic memory, and long-term effects were overall modest. The proposed
R01 renewal proposes to identify additional attributes to further enhance transferred and
long-term effects of PS/A training in older adults with amnestic mild cognitive impairment
(MCI) by addressing adaptation capacity that underpins adaptive learning and neuroplasticity.
The goal of the stage II double-blinded randomized trial is to test whether adding resonance
frequency breathing (RFB) training to VSOP will strengthen multiple contributors to
adaptation capacity, particularly the central and peripheral pathways of autonomic nervous
system (ANS) flexibility, which will strengthen VSOP training effect on cognitive and brain
function and slow the progress of dementia in MCI. The central hypothesis is that
strengthening adaptation capacity, via improving autonomic nervous system (ANS) flexibility,
will enhance neuroplasticity and slow progress of dementia in MCI, since adaptation capacity
is critical for neuroplasticity of VSOP, but compromised in neurodegenerative process. Older
adults with MCI (n = 114) will be randomly assigned to an 8-week combined intervention
(RFB+VSOP), VSOP with guided imagery relaxation (IR) control, and a waitlist IR control, with
periodical booster training sessions at follow-ups. Mechanistic and distal outcomes include
ANS flexibility and multiple markers of dementia progress. Data will be collected across a
14-month period. The two primary aims are to examine long-term effects of the combined
intervention on ANS flexibility (Aim 1), as well as the cognitive, behavioral, and functional
capacity (Aim 2). The exploratory aim will be to determine the preliminary long-term effect
of the combined intervention on neurodegeneration. This can be a reasonable renewal plan from
the completed study, aiming to identify additional attributes to further enhance transferred
and long-term effects of cognitive training in MCI. This will be among the first randomized
controlled trials to examine a novel, combined intervention targeting adaptation capacity in
MCI, with an ultimate goal for slowing neurodegeneration.
In addition, research on how to monitor adherence - the extent to which VSOP training is
delivered and followed as intended - has been conceptually and methodologically limited.
Robust monitoring of adherence to cognitive training requires valid assessment of effective
engagement. Here, we apply our well-supported, novel framework of mental fatigability for
measuring effective engagement in cognitive training. Mental fatigability, the failure to
remain engaged in tasks requiring sustained mental effort, can be captured via measures of
self-reported disengagement, increase in reaction time during tasks, and facial expression of
negative valence/low arousal. These markers of disengagement relate to ventromedial
prefrontal cortex dysfunction. We will apply this framework to advance understanding of the
underpinnings of adherence to VSOP training by monitoring the extent of effective engagement
while using the training platform.
Official Title
Breathing, Relaxation, Attention Training, & Health in Older Adults
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
1. All participants will require a diagnosis of "mild cognitive impairment due to
Alzheimer's disease"using the most recent NIA and Alzheimer's Association workshop
criteria:
1. Presence of memory complaint,
2. Rey Auditory Verbal Learning Test delayed recall (for memory) < 6,
3. Montreal Cognitive Assessment (for global cognition) ranged 18 and 25,
4. Activities of Daily Living Questionnaire ≤ 30,
2. Intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
3. If a participant is on Alzheimer's disease medication (i.e., memantine or
cholinesterase inhibitors), antidepressants, anxiolytics, or vascular risk or diseases
related medications (e.g., beta- blocker), the dose should be stable for 3 months
prior to recruitment.
4. Age 60-89,
5. English-speaking,
6. Adequate visual and hearing acuity for using mobile-based apps and testing by
self-report, and
7. Community-dwelling.
Exclusion Criteria:
1. Current enrollment in another cognitive improvement study;
2. Uncontrollable symptoms of major depression;
3. Major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure,
pacemaker, prior myocardial infarction);
4. Neurological diseases (e.g., Parkinson's disease, Multiple Sclerosis);
5. Having an active legal guardian (indicating impaired capacity for decision making);
6. MRI contraindication (e.g., pacemaker, claustrophobia).
7. Color blindedness
8. Alcohol dependency in the past 5 years that are the main contributor to MCI
Intervention(s):
behavioral: RFB
behavioral: VSOP
behavioral: IR
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305