search
Back to results

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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kundalini yoga and meditation
Memory Training
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Memory impairment, Meditation, Yoga, memory training, Mild cognitive impairment, MCI, geriatric, fMRI

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Semel Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Memory Training

Kundalini yoga and meditation

Arm Description

Group memory training will be administered for amnestic mild cognitive impairment (MCI)

Participants will engage in weekly yoga classes and daily 20 minute meditation

Outcomes

Primary Outcome Measures

Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score
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

Clinical Global Impression Scale
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)
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
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.

Full Information

First Posted
October 30, 2013
Last Updated
December 14, 2017
Sponsor
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT01983930
Brief Title
Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
Official Title
Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Memory impairment, Meditation, Yoga, memory training, Mild cognitive impairment, MCI, geriatric, fMRI

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Training
Arm Type
Active Comparator
Arm Description
Group memory training will be administered for amnestic mild cognitive impairment (MCI)
Arm Title
Kundalini yoga and meditation
Arm Type
Experimental
Arm Description
Participants will engage in weekly yoga classes and daily 20 minute meditation
Intervention Type
Behavioral
Intervention Name(s)
Kundalini yoga and meditation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Memory Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score
Description
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.
Time Frame
At baseline and at 6 months
Secondary Outcome Measure Information:
Title
Clinical Global Impression Scale
Description
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).
Time Frame
Baseline, weeks 2, 4, 6, 8, 10, 12, 24
Title
Geriatric Depression Scale (GDS)
Description
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.
Time Frame
Baseline and Week 24
Title
Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Lavretsky, MD, MS
Organizational Affiliation
UCLA Semel Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Semel Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28088925
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs