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Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cogmed
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring Hypertension, Cognition, Computerized Training, Cogmed

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regina Silva Paradela

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive training group

Active control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Working memory score
Backward Digits Test / Letter-Number Sequencing (WAIS-III): total score (sum of right answers)

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2016
Last Updated
November 16, 2021
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02738034
Brief Title
Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment
Official Title
Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Cognition, Computerized Training, Cogmed

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adaptive training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Active control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cogmed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Working memory score
Description
Backward Digits Test / Letter-Number Sequencing (WAIS-III): total score (sum of right answers)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Brain function
Description
Functional magnetic resonance
Time Frame
10 weeks
Title
Executive functions score
Description
Stroop test, Wisconsin Card Sorting Test, Frontal Assessment Battery and Controlled Oral Word Association Test
Time Frame
10 weeks
Title
Verbal memory score
Description
Stories of Wechsler Memory Scale Revised - WMS R
Time Frame
10 weeks
Title
Visual memory score
Description
Rey complex figure
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Medication adherence score
Description
Short version of Morinsk Questionnaire
Time Frame
10 weeks
Title
Quality of life score
Description
Whoqol
Time Frame
10 weeks
Title
Perceived Stress score
Description
PSS14
Time Frame
10 weeks
Title
Anxiety and Depression symptoms score
Description
BAI and BDI questionnaires
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Regina Silva Paradela
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil

12. IPD Sharing Statement

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Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment

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