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临床试验/NCT04522791
NCT04522791已完成不适用

Breathing, Relaxation, Attention Training, & Health in Older Adults

University of Rochester2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2020年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
2
主要终点
change of ANS flexibility at 14 months from baseline

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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:
  • Presence of memory complaint,
  • Rey Auditory Verbal Learning Test delayed recall (for memory) < 6,
  • Montreal Cognitive Assessment (for global cognition) ranged 18 and 25,
  • Activities of Daily Living Questionnaire ≤ 30,
  • Intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
  • 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.
  • English-speaking,
  • Adequate visual and hearing acuity for using mobile-based apps and testing by self-report, and
  • Community-dwelling.

排除标准

  • Current enrollment in another cognitive improvement study;
  • Uncontrollable symptoms of major depression;
  • Major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction);
  • Neurological diseases (e.g., Parkinson's disease, Multiple Sclerosis);
  • Having an active legal guardian (indicating impaired capacity for decision making);
  • MRI contraindication (e.g., pacemaker, claustrophobia).
  • Color blindedness
  • Alcohol dependency in the past 5 years that are the main contributor to MCI

研究组 & 干预措施

RFB+VSOP (MCI)

Experimental

For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.

A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.

干预措施: RFB (Behavioral)

RFB+VSOP (MCI)

Experimental

For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.

A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.

干预措施: VSOP (Behavioral)

IR+VSOP (MCI)

Active Comparator

The control IR strategy will be used, set-up of which will be the same as the RFB + VSOP intervention group with IR replacing RFB. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.

干预措施: VSOP (Behavioral)

IR+VSOP (MCI)

Active Comparator

The control IR strategy will be used, set-up of which will be the same as the RFB + VSOP intervention group with IR replacing RFB. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.

干预措施: IR (Behavioral)

IR only (MCI)

Placebo Comparator

Participants randomized to this condition will receive weekly in-person check-in visits, and perform daily 10-minute IR, so that the number of treatment contacts (though not duration) will be equivalent. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.

干预措施: IR (Behavioral)

RFB+VSOP (HC)

Other

this is a new healthy control intervention arm used for testing adherence related items.

For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.

A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.

干预措施: RFB (Behavioral)

RFB+VSOP (HC)

Other

this is a new healthy control intervention arm used for testing adherence related items.

For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.

A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.

干预措施: VSOP (Behavioral)

结局指标

主要结局

change of ANS flexibility at 14 months from baseline

时间窗: 14 months post-baseline

A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.

change of ANS flexibility at 2 months from baseline

时间窗: 2 months post-baseline

A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.

change of cognition at 2 months from baseline

时间窗: 2 months post-baseline

A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated. Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated. A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.

change of ANS flexibility at 8 months from baseline

时间窗: 8 months post-baseline

A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.

change of cognition at 8 months from baseline

时间窗: 8 months post-baseline

A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated. Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated. A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.

change of cognition at 14 months from baseline

时间窗: 14 months post-baseline

A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated. Visual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated. A composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.

次要结局

  • change of instrumental activities of daily living function (IADL) at 8 months from baseline(8 months post-baseline)
  • change of instrumental activities of daily living function (IADL) at 2 months from baseline(2 months post-baseline)
  • change of instrumental activities of daily living function (IADL) at 14 months from baseline(14 months post-baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathi Heffner

Associate Professor of Psychiatry

University of Rochester

研究点 (2)

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