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

Peking University

Status: Invitation-only

Conditions: Aging; Hypertension; Condition

Treatments: Device: adaptive cognitive training; Device: placebo cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT06512922

CMB22-466

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 2 patient groups

adaptive cognitive training

Experimental group

Description:

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.

Treatment:

Device: adaptive cognitive training

placebo cognitive training

Active Comparator group

Description:

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.

Treatment:

Device: placebo cognitive training