NCT02738034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2020

Enrollment Period

4.2 years

First QC Date

March 23, 2016

Last Update Submit

November 16, 2021

Conditions

Hypertension

Keywords

HypertensionCognitionComputerized TrainingCogmed

Outcome Measures

Primary Outcomes (1)

  • Working memory score

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

    10 weeks

Secondary Outcomes (4)

  • Brain function

    10 weeks

  • Executive functions score

    10 weeks

  • Verbal memory score

    10 weeks

  • Visual memory score

    10 weeks

Other Outcomes (4)

  • Medication adherence score

    10 weeks

  • Quality of life score

    10 weeks

  • Perceived Stress score

    10 weeks

  • +1 more other outcomes

Study Arms (2)

Adaptive training group

EXPERIMENTAL

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

Active control Group

ACTIVE COMPARATOR

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

Interventions

CogmedOTHER

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 control GroupAdaptive training group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Silva Paradela

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 14, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

November 17, 2021

Record last verified: 2020-11

Locations

BR(1)