Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment

Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment: a Randomized Clinical Trial

Systemic arterial hypertension is a disease with high prevalence in several countries, including Brazil. Many studies have correlated hypertension with accelerated loss of cognitive function, especially executive functions. There is some evidence that working memory (WM) is compromised in these populations. However, some computerized training has been developed to rehabilitate the WM, and among them the investigators highlight the Cogmed. Thus, the aim of this study is to evaluate the effects of Cogmed training in the performance of WM and attention of hypertensive patients, as well as the impact of training in the structure and brain function.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Cogmed

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 05403-900
      • Regina Silva Paradela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals of both genders, of any ethnicity
• Signing the consent form
• Access to computer with internet at home
• Inexperienced to computerized cognitive training
• Hypertensive pre-diagnosed
• Basic schooling of four years
• Cognitive impairment

Exclusion Criteria:

• Marked functional limitation
• Cognitive limitation or serious communication
• Severe neurological and psychiatric diseases
• Stroke history, head trauma or substance abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adaptive training group; The intervention group will be composed of hypertensive participants with cognitive decline that will be submitted to the training program (Cogmed) for approximately 10 weeks. Across training, task difficulty was adjusted as a function of individual performance.	Other: Cogmed; The Cogmed is computer software designed to train visuospatial and audio-verbal working memory, and other functions associated with working memory: attention, focus and impulsiveness. It has three versions adapted to different age groups: Cogmed for younger children, about 4-7 years, which are not yet so familiar with numbers and letters; Cogmed for children over 7 years and adolescents; and Cogmed for youth and adults over 18 years. In this study we will use the version for youth and adults over 18 years.
Active Comparator: Active control Group; In the control group, hypertensive patient will be submitted to a set of online games available on the internet and previously determined. In this way, the control group will receive the same motivation, as well as will be engaged in computerized activities, in the same way as the experimental group. The difference is that these varied games do not provide any type of intense and adaptive training, at the same time as they do not stimulate any specific cognitive function.	Other: Cogmed; The Cogmed is computer software designed to train visuospatial and audio-verbal working memory, and other functions associated with working memory: attention, focus and impulsiveness. It has three versions adapted to different age groups: Cogmed for younger children, about 4-7 years, which are not yet so familiar with numbers and letters; Cogmed for children over 7 years and adolescents; and Cogmed for youth and adults over 18 years. In this study we will use the version for youth and adults over 18 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working memory score	Backward Digits Test / Letter-Number Sequencing (WAIS-III): total score (sum of right answers)	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain function	Functional magnetic resonance	10 weeks
Executive functions score	Stroop test, Wisconsin Card Sorting Test, Frontal Assessment Battery and Controlled Oral Word Association Test	10 weeks
Verbal memory score	Stories of Wechsler Memory Scale Revised - WMS R	10 weeks
Visual memory score	Rey complex figure	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence score	Short version of Morinsk Questionnaire	10 weeks
Quality of life score	Whoqol	10 weeks
Perceived Stress score	PSS14	10 weeks
Anxiety and Depression symptoms score	BAI and BDI questionnaires	10 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Hypertension; Cognition; Cogmed; Computerized Training
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Neurocognitive Disorders; Cognition Disorders; Hypertension; Cognitive Dysfunction
• Other Study ID Numbers: CogDoc2016