Adaptive Cognitive Training on Cognitive Function in Elderly Hypertension Patients in the Community

NCT ID: NCT06512922

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2027-06-30

Brief Summary

Objective A growing body of evidence supports hypertension as a risk factor for cognitive decline. Hypertension is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairmentof older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community.

Participants aged 60 years or older, diagnosis of hypertension, and cognitive function assessment showed no dementia.

Design The study was designed as a double-blind randomized controlled trial. 120 hypertension participants without dementia aged 60 years or older in Shijingshan and Haidian, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 12 weeks and follow up to 24 weeks, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to the end of the 12-week intervention.

The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (approval number: 2024-162).

Conditions

Hypertension; Condition; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

adaptive cognitive training

The intervention lasted for 12 weeks. Participants will receive 30 minutes of training per day, at least five days per week. In each task, once a high accuracy (e.g. \>80%) is achieved, the task is automatically upgraded to the next difficulty level.

Group Type: EXPERIMENTAL

adaptive cognitive training

Intervention Type: DEVICE

The intervention was computerized, multi-domain, adaptive cognitive training. Training areas include processing speed, attention, perception, long-term memory, working memory, computation, executive control, reasoning, and problem-solving. Embedded in the Adaptive Cognitive training application is an adaptive algorithm that will help provide each participant with a cognitive training task at the right level of difficulty based on their profile and real-time performance.

placebo cognitive training

The intervention lasted for 12 weeks. Participants will receive 30 minutes of training per day, at least five days per week. The tasks will be set to a fixed level of difficulty.

Group Type: ACTIVE_COMPARATOR

placebo cognitive training

Intervention Type: DEVICE

They received cognitive training tasks of fixed difficulty.

Interventions

adaptive cognitive training

The intervention was computerized, multi-domain, adaptive cognitive training. Training areas include processing speed, attention, perception, long-term memory, working memory, computation, executive control, reasoning, and problem-solving. Embedded in the Adaptive Cognitive training application is an adaptive algorithm that will help provide each participant with a cognitive training task at the right level of difficulty based on their profile and real-time performance.

Intervention Type: DEVICE

placebo cognitive training

They received cognitive training tasks of fixed difficulty.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

(1) Could not complete neuropsychological tests; (2) Suffering other disease or medication use might affect cognitive function, such as a new stroke within 6 months before baseline or use tranquilizers; (3) Unable to use PADs or unable to complete the training; (4) Unacceptable or refuse to participate in cognitive training; (5) Living in the same family with a subject who has been randomly assigned.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Wuxiang Xie

Researcher, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xihuangcun Hospital

Beijing, Shijingshan, China

Countries

China

Other Identifiers

CMB22-466

Identifier Type: -

Identifier Source: org_study_id