Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738034
• Other study ID #: CogDoc2016
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Brazil	Regina Silva Paradela	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication adherence score	Short version of Morinsk Questionnaire	10 weeks
Other	Quality of life score	Whoqol	10 weeks
Other	Perceived Stress score	PSS14	10 weeks
Other	Anxiety and Depression symptoms score	BAI and BDI questionnaires	10 weeks
Primary	Working memory score	Backward Digits Test / Letter-Number Sequencing (WAIS-III): total score (sum of right answers)	10 weeks
Secondary	Brain function	Functional magnetic resonance	10 weeks
Secondary	Executive functions score	Stroop test, Wisconsin Card Sorting Test, Frontal Assessment Battery and Controlled Oral Word Association Test	10 weeks
Secondary	Verbal memory score	Stories of Wechsler Memory Scale Revised - WMS R	10 weeks
Secondary	Visual memory score	Rey complex figure	10 weeks