Abstract
Importance
Cognitive training with components that can further enhance the transferred and long-term effects and slow the progress of dementia is needed for preventing dementia.
Objective
The goal of the study is to test whether improving autonomic nervous system (ANS) flexibility via a resonance frequency breathing (RFB) training will strengthen the effects of a visual speed of processing (VSOP) cognitive training on cognitive and brain function, and slow the progress of dementia in older adults with mild cognitive impairment (MCI).
Design
Stage II double-blinded randomized controlled trial. The study was prospectively registered at ClinicalTrials.gov, with registration approved on 21 August 2020 (No. NCT04522791).
Setting
Study-related appointments will be conducted on-site at University of Rochester Medical Center locations. Data collection will be conducted from August 2020 to February 2025.
Participants
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 IR-only control, with periodical booster training sessions at follow-ups. Mechanistic and distal outcomes include ANS flexibility, measured by heart rate variability, and multiple markers of dementia progress. Data will be collected across a 14-month period.
Discussion
This will be among the first RCTs to examine in older persons with MCI a novel, combined intervention targeting ANS flexibility, an important contributor to overall environmental adaptation, with an ultimate goal for slowing neurodegeneration.
Trial registration
ClinicalTrials.gov NCT04522791. Registered on 21 August 2020
Protocol version: STUDY00004727; IRB protocol version 2, approved on 30 July 2020.
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Details
; Heffner, Kathi 2 ; Gevirtz, Richard 3 ; Zhang, Zhengwu 4 ; Tadin, Duje 5 ; Porsteinsson, Anton 6 1 Stanford University, Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford, USA (GRID:grid.168010.e) (ISNI:0000000419368956); Stanford University, Wu Tsai Neuroscience Institute, Stanford, USA (GRID:grid.168010.e) (ISNI:0000000419368956); University of Rochester Medical Center, Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, Rochester, USA (GRID:grid.412750.5) (ISNI:0000 0004 1936 9166); University of Rochester, Department of Brain and Cognitive Sciences, Rochester, USA (GRID:grid.16416.34) (ISNI:0000 0004 1936 9174)
2 University of Rochester Medical Center, Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, Rochester, USA (GRID:grid.412750.5) (ISNI:0000 0004 1936 9166); University of Rochester Medical Center, Department of Medicine, School of Medicine and Dentistry, Rochester, USA (GRID:grid.412750.5) (ISNI:0000 0004 1936 9166); University of Rochester Medical Center, Department of Psychiatry, School of Medicine and Dentistry, Rochester, USA (GRID:grid.412750.5) (ISNI:0000 0004 1936 9166)
3 Alliant International University, San Diego, USA (GRID:grid.252048.9) (ISNI:0000 0001 2286 2419)
4 University of North Carolina-Chapel Hill, Chapel Hill, USA (GRID:grid.10698.36) (ISNI:0000000122483208)
5 University of Rochester, Department of Brain and Cognitive Sciences, Rochester, USA (GRID:grid.16416.34) (ISNI:0000 0004 1936 9174); University of Rochester Medical Center, Department of Neuroscience, School of Medicine and Dentistry, Rochester, USA (GRID:grid.412750.5) (ISNI:0000 0004 1936 9166)
6 University of Rochester Medical Center, Department of Psychiatry, School of Medicine and Dentistry, Rochester, USA (GRID:grid.412750.5) (ISNI:0000 0004 1936 9166)




