Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment

April 20, 2015 updated by: José Alberto Ávila Funes, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Supervised nonpharmacologic therapy improve cognitive function in patients with Mild Cognitive Impairment

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14000
        • National Institue of Medical Sciences and Nutrition Salvador Zubirán

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 60 years and older with Mild Cognitive Impairment according to Petersen Criteria
  • Phone number available

Exclusion Criteria:

  • Untreated depression
  • Evidence of a reversible cause of cognitive decline
  • Dementia of any type and stage
  • Severe sensory deficit unresolved
  • Metastatic cancer
  • Hemoglobin level < 8g/dL
  • Chronic Obstructive Pulmonary Disease Gold stage 3 or 4
  • Congestive Heart Failure decompensated, unstable angina o Functional Class IV according to New York Heart Association
  • Participation in another protocol that prevents its participation in this research
  • Chronic use of benzodiazepines, tricyclic antidepressants
  • Patients whose place of residence can not attend the sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Non-pharmacological therapy
This group will be supervised nonpharmacologic therapy
Other: Non-pharmacological therapy
It consists of a weekly two-hour session. During the first hour yoga classes will taught by teacher, during second hour supervised cognitive training by a psychologist based on Memory Program designed by Memory Unit of Madrid
Other Names:
  • Supervised nonpharmacologic therapy
NO_INTERVENTION: Control
This group will receive the standard treatment for mild cognitive impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: six months
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) sum of boxes after non-pharmacological intervention for six months.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function six months after completing intervention
Time Frame: one year
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) six months after completing intervention
one year
Depressive symptoms
Time Frame: six months
Depressive symptoms measured by Geriatric Depression Scale (GDS) before and after intervention period
six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: six months
Quality of life measured by a scale validated in Spanish before and after intervention period
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

  • Principal Investigator: JOSÉ ALBERTO MD ÁVILA, Geriatrician, National Institute of Medical Sciences and Nutrition Salvador Zubiran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (ESTIMATE)

March 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-830-13/14-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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