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

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ClinicalTrials.gov Identifier: NCT01983930
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Helen Lavretsky, MD, University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Kundalini yoga and meditation Behavioral: Memory Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
Study Start Date : September 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Memory Training
Group memory training will be administered for amnestic mild cognitive impairment (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.




Primary Outcome Measures :
  1. Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score [ Time Frame: At baseline and at 6 months ]
    Primary outcome measures were administered by a cognitive battery of neuropsychological and included memory and executive functioning. Verbal memory was measured with the Hopkins Verbal Learning Test (HVLT) total recall scores. The HVLT form contains 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. When scoring the HVLT, the three learning trials are combined to calculate a total recall score. Total scores range from 0-36 with higher scores indicating better outcome.


Secondary Outcome Measures :
  1. Clinical Global Impression Scale [ Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 24 ]
    The CGI measures severity of illness and global improvement. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI global improvement scores range from 1 (very much improved) through to 7 (very much worse).

  2. Geriatric Depression Scale (GDS) [ Time Frame: Baseline and Week 24 ]
    Secondary outcomes measures included mood assessments with the GDS, a self-assessment scale often used in geriatric depression trials. The GDS is a 30-item screening tool used to identify depression in older adults. In scoring the Geriatric Depression Scale, each item is scored 0 or 1. The total score on the scale ranges from 0 to 30 with higher scores indicating worse outcome.

  3. Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity [ Time Frame: 12 weeks ]
    FMRI scans will be obtained at baseline and after 12 weeks follow up. Default mode network findings were analyzed and significant effects were identified for yoga and memory enhancement training groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 memory enhancement training (MET) (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983930


Locations
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United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Helen Lavretsky, MD, MS UCLA Semel Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helen Lavretsky, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01983930     History of Changes
Other Study ID Numbers: 13-000821
First Posted: November 14, 2013    Key Record Dates
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helen Lavretsky, MD, University of California, Los Angeles:
Memory impairment
Meditation
Yoga
memory training
Mild cognitive impairment
MCI
geriatric
fMRI
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders