Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 30, 2013
First Posted Date  ICMJE November 14, 2013
Results First Submitted Date  ICMJE April 10, 2017
Results First Posted Date  ICMJE October 23, 2018
Last Update Posted Date October 23, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
Change in memory [ Time Frame: At baseline and at 6 months ]
As measured by battery of neuropsychological tests
Change History Complete list of historical versions of study NCT01983930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
  • Clinical Global Impression Scale [ Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 24 ]
  • Geriatric Depression scale [ Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 24 ]
  • Change in fMRI connectivity [ Time Frame: 12 weeks ]
    FMRI scans will be obtained at baseline and after 12 weeks follow up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
Official Title  ICMJE Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Memory Training
    Group memory training will be administered for amnestic mild cognitive impairment (MCI)
    Intervention: Behavioral: Memory Training
  • Experimental: Kundalini yoga and meditation
    Participants will engage in weekly yoga classes and daily 20 minute meditation
    Intervention: Behavioral: Kundalini yoga and meditation
Publications * Eyre HA, Siddarth P, Acevedo B, Van Dyk K, Paholpak P, Ercoli L, St Cyr N, Yang H, Khalsa DS, Lavretsky H. A randomized controlled trial of Kundalini yoga in mild cognitive impairment. Int Psychogeriatr. 2017 Apr;29(4):557-567. doi: 10.1017/S1041610216002155. Epub 2017 Jan 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2017)
81
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2013)
66
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01983930
Other Study ID Numbers  ICMJE 13-000821
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helen Lavretsky, MD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Helen Lavretsky, MD, MS UCLA Semel Institute
PRS Account University of California, Los Angeles
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP