Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Helen Lavretsky, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01983930
First received: October 30, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The purpose of this pilot study is to test whether 6 months of supervised weekly Kundalini yoga classes and a brief daily meditation homework assignment can improve memory and thinking in older adults with mild memory complaints when compared to weekly classes of memory training with daily homework assignments.


Condition Intervention
Mild Cognitive Impairment
Behavioral: Kundalini yoga and meditation
Behavioral: Memory Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in memory [ Time Frame: At baseline and at 6 months ] [ Designated as safety issue: No ]
    As measured by battery of neuropsychological tests


Secondary Outcome Measures:
  • Clinical Global Impression scale [ Time Frame: Baseline, weeks 2,4,6,8,10,12,24 ] [ Designated as safety issue: No ]
  • Geriatric Depression scale [ Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 24 ] [ Designated as safety issue: No ]
  • Change in fMRI connectivity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    FMRI scans will be obtained at baseline and after 12 weeks follow up


Estimated Enrollment: 66
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Memory Training
Group memory training will be administered for amnestic MCI
Behavioral: Memory Training
Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.
Experimental: Kundalini yoga and meditation
PArticipants will engage in weekly yoga classes and daily 20 minute meditation
Behavioral: Kundalini yoga and meditation
Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan kriya meditation (12 minute duration) for 12 weeks.
Other Name: Kundalini yoga and meditation

Detailed Description:

The purpose of this pilot study intervention is to investigate brain mechanisms of response to memory enhancement training (MET) compared to Kundalini yoga and Kirtan Kriya meditation using functional magnetic resonance imaging (fMRI) that will be acquired from each subject at baseline and at 12 weeks (post-randomization).

Overall, the investigators anticipate recruiting 66 adults with memory complaints and diagnosed with MCI for adults 55 years old and older. Subjects will either receive: (1) MET class for 60 minutes per week; or (2) Kundalini yoga and Kirtan Kriya meditation class for 60 minutes per week. All assessments will be completed immediately after the interventions for a total of 10 visits in 12 weeks and a follow-up visit at 6 months (24 weeks)to monitor the overall benefit of the intervention.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild cognitive impairment amnestic type
  • Clinical Dementia Rating scale score of 0.5
  • SufficientEnglish proficiency and 8th grade or higher reading level as determined by the word reading subtest of the Wide Range Achievement Test-IV
  • Capacity to provide informed consent.

Exclusion criteria:

  • Any current or past psychiatric disorders, or recent unstable medical or neurological disorders
  • Any disabilities preventing their participation in the MET or HEW (e.g. severe visual or hearing impairment)
  • Insufficient English proficiency
  • Diagnosis of dementia
  • Mini Mental Health Examination score of 24 and below
  • Psychoactive medications
  • Participation in a psychotherapy that involves cognitive training
  • Do not meet criteria for Mild cognitive impairment subtype
  • Prior or current training in yoga.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983930

Contacts
Contact: Irena Chuchev 310-794-9523 ichuchev@mednet.ucla.edu
Contact: Natalie St. Cyr, MA 310-983-3375 nstcyr@mednet.ucla.edu

Locations
United States, California
UCLA Semel Institute Recruiting
Los Angeles, California, United States, 90095
Contact: Natalie St. Cyr, MA    310-983-3375    nstcyr@mednet.ucla.edu   
Principal Investigator: Helen Lavretsky, MD, MS         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Helen Lavretsky, MD, MS UCLA Semel Institute
  More Information

No publications provided

Responsible Party: Helen Lavretsky, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01983930     History of Changes
Other Study ID Numbers: 13-000821
Study First Received: October 30, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Memory impairment
Meditation
Yoga
memory training
Mild cognitive impairment
MCI
geriatric
fMRI

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014