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OpenTrials
Completed

NCT Number: NCT02738034

Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regina Silva Paradela

São Paulo, 05403-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CogMed

Other

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 outcomes

  1. Working memory score

    Time frame: 10 weeks

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

Secondary outcomes

  1. Brain function

    Time frame: 10 weeks

    Functional magnetic resonance

  2. Executive functions score

    Time frame: 10 weeks

    Stroop test, Wisconsin Card Sorting Test, Frontal Assessment Battery and Controlled Oral Word Association Test

  3. Verbal memory score

    Time frame: 10 weeks

    Stories of Wechsler Memory Scale Revised - WMS R

  4. Visual memory score

    Time frame: 10 weeks

    Rey complex figure

Other outcomes

  1. Medication adherence score

    Time frame: 10 weeks

    Short version of Morinsk Questionnaire

  2. Quality of life score

    Time frame: 10 weeks

    Whoqol

  3. Perceived Stress score

    Time frame: 10 weeks

    PSS14

  4. Anxiety and Depression symptoms score

    Time frame: 10 weeks

    BAI and BDI questionnaires

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2016
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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