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. 2025 Feb 21;26(1):64.
doi: 10.1186/s13063-025-08745-6.

The efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol for a randomized controlled trial

Yi Ye #  1 , Qing Chen #  1 , Ruixuan Li  2 , Xiaoyi Wang  2 , Yueling Sun  3 , Fangjiang Li  4 , Xiaoping Liu  5 , Le Wang  6 , Xinhui Ning  7 , Hongsen Tian  8 , Wei Zhao  9 , Changsheng Ma  1 , Hongjia Zhang  1 , Yong Zeng  10
Affiliations

The efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol for a randomized controlled trial

Yi Ye et al. Trials. .

Abstract

Background: Cognitive training has been confirmed to significantly improve the overall cognitive function in patients. For patients with coronary heart disease, in addition to controlling common risk factors, there is a lack of effective evidence for the treatment of cognitive function in patients with coronary heart disease and its effectiveness. This randomized controlled study was designed to evaluate the effectiveness of computer-based cognitive training for improving cognitive function in such patients.

Methods: COG-T CHD is a multicenter, double-blind, parallel-designed, randomized controlled trial. The patients will be divided 1:1 into two groups by a central randomized system, a cognitive digital therapy group or a positive control group. Patients assigned to the cognitive digital therapy group will undergo computer-based cognitive training for 30 min at least five times a week for 12 weeks. At the end of the 12 weeks, the subjects were randomly divided into two groups. One group continued the 12 weeks of cognitive digital therapy training and the other group stopped the training. Patients assigned to the positive control group will undergo computer-based cognitive training with little or no difficulty changes for 30 min at least five times a week for 12 weeks. The study will last approximately 2 years, with enrollment completed in approximately 18 months, with the last enrolled patient followed for at least 24 weeks. The primary outcome is the proportion of improvement in overall cognitive function at 12 weeks, using the Basic Cognitive Ability Test (BCAT). Secondary outcomes are the proportion of improvement in the overall cognitive function from baseline at 24 weeks, the change in overall cognitive function scores at 12 and 24 weeks, and the proportion of improvement in each cognitive domain, General Self-Efficacy Scale score, EuroQol five-dimension three-level questionnaire score, and Generalized Anxiety Disorder-7 score at 12 and 24 weeks from baseline. The investigational outcome is the change in head MRI structure and function from baseline at weeks 12/24.

Discussion: COG-T CHD is the first clinical trial to evaluate the efficacy of computer-based cognitive training in patients with coronary heart disease, filling an important gap in the treatment evidence for cognitive digital therapy.

Trial registration: ClinicalTrials.gov, NCT05735041. Registered on Jan. 18, 2023.

Keywords: Computerized cognitive training; Coronary heart disease; Mild cognitive impairment; RCT.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate {24}: The research protocol has been reviewed and approved by the Ethics Committee of Beijing Anzhen Hospital affiliated to Capital Medical University (Ethics code: (2022) Research Review No. (17–2)). All eight centers (Beijing Anzhen Hospital affiliated to Capital Medical University, Peking University Third Hospital, The Second Hospital of Chifeng, The First Affiliated Hospital of Hebei North University, Handan Central Hospital, The First Hospital of Hebei Medical University, Beijing Sixth Hospital, Inner Mongolia Ordos Central Hospital Kangbashi Department) involved in the study have received ethical approval. The design, implementation, and reporting of this study protocol shall comply with ICH-GCP, applicable local regulations and the ethical provisions of the World Medical Association (WMA) Declaration of Helsinki. Prior to subject registration, the Ethics Committee overseeing the study will review and approve the study protocol, information about the subjects expected to be enrolled, informed consent, and any subsequent modifications. Prior to the start of the study, the principal investigator must sign the Study Protocol Signature page confirming that he/she agrees to conduct the study in accordance with the study documentation and the instructions and procedures in this study protocol, and to provide all relevant data and records to the auditors, inspectors, IRB/ECs, and regulatory authorities as required. If regulators require an inspection of a participating clinical center, the investigator must notify the CRO immediately. Consent for publication {32}: Not applicable. Competing interests {28}: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Participant flow through study
Fig. 2
Fig. 2
Cognitive training task adapted from the classic Stroop effect paradigm: the patients must pay attention to the color of the balloons and the content of the words and click on the balloons whose color does not match the written description
Fig. 3
Fig. 3
Cognitive training task adapted from the classic psychological paradigm size-matching task: the patients need to select the image from the three options below that have the same size as the image displayed above
Fig. 4
Fig. 4
Sample size
See this image and copyright information in PMC

References

    1. Sachdev P, Andrews G, Hobbs MJ, Sunderland M, Anderson TM. Neurocognitive disorders: cluster 1 of the proposed meta-structure for DSM-V and ICD-11. Psychol Med. 2009;39(12):2001–12. - PubMed
    1. Jia L, Du Y, Chu L, Zhang Z, Li F, Lyu D, et al. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health. 2020;5(12):e661–71. - PubMed
    1. Song R, Xu H, Dintica CS, Pan KY, Qi X, Buchman AS, et al. Associations Between cardiovascular risk, structural brain changes, and cognitive decline. J Am Coll Cardiol. 2020;75(20):2525–34. - PMC - PubMed
    1. Rosengart TK, Sweet J, Finnin EB, Wolfe P, Cashy J, Hahn E, et al. Neurocognitive functioning in patients undergoing coronary artery bypass graft surgery or percutaneous coronary intervention: evidence of impairment before intervention compared with normal controls. Ann Thorac Surg. 2005;80(4):1327–34 discussion 1334-1335. - PubMed
    1. Saleem M, Herrmann N, Dinoff A, Mazereeuw G, Oh PI, Goldstein BI, et al. Association between endothelial function and cognitive performance in patients with coronary artery disease during cardiac rehabilitation. Psychosom Med. 2019;81(2):184–91. - PMC - PubMed

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