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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Mild Cognitive Impairment
Interventions Behavioral: Kundalini yoga and meditation
Behavioral: Memory Training
Enrollment 81
Recruitment Details Single site outpatient clinic in the U.S.
Pre-assignment Details 168 volunteers were assessed for eligibility, of which 51 declined to participate and 32 did not meet inclusion criteria. Eighty-five volunteers consented to participate, of which 81 passed screening and were enrolled; two of 81 enrolled participants withdrew post-randomization and did not receive the allocated intervention.
Arm/Group Title Memory Training Kundalini Yoga and Meditation
Hide Arm/Group Description

Group memory training will be administered for amnestic MCI

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.

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

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.

Period Title: Overall Study
Started 41 38
Completed 32 29
Not Completed 9 9
Reason Not Completed
Withdrawal by Subject             9             8
Adverse Event             0             1
Arm/Group Title Memory Training Kundalini Yoga and Meditation Total
Hide Arm/Group Description

Group memory training will be administered for amnestic MCI

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.

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

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.

Total of all reporting groups
Overall Number of Baseline Participants 41 38 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 38 participants 79 participants
68.1  (8.7) 67.6  (8.0) 67.9  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 38 participants 79 participants
Female 27 25 52
Male 14 13 27
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 38 participants 79 participants
Caucasian 30 24 54
Non-Caucasian 11 14 25
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 41 participants 38 participants 79 participants
41 38 79
1.Primary Outcome
Title Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memory Training Kundalini Yoga and Meditation
Hide Arm/Group Description:

Group memory training will be administered for amnestic MCI.

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.

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

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.

Overall Number of Participants Analyzed 41 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 26.02  (5.42) 25.76  (6.20)
6 Months 27.96  (5.44) 28.81  (6.52)
2.Secondary Outcome
Title Clinical Global Impression Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Memory Training Kundalini Yoga and Meditation
Hide Arm/Group Description:

Group memory training will be administered for amnestic MCI.

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.

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

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Geriatric Depression Scale (GDS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memory Training Kundalini Yoga and Meditation
Hide Arm/Group Description:

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

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.

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

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.

Overall Number of Participants Analyzed 41 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.7  (5.6) 7.5  (5.1)
Week 24 3.2  (2.5) 3.9  (2.5)
4.Secondary Outcome
Title Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memory Training Kundalini Yoga and Meditation
Hide Arm/Group Description:

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

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.

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

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.

Overall Number of Participants Analyzed 11 14
Measure Type: Number
Unit of Measure: p-value
pregenual anterior cingulate cortex (ACC) p-value 0.011 0.001
frontal medial cortex (FMC) p-value 0.035 0.001
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memory Training Kundalini Yoga and Meditation
Hide Arm/Group Description

Group memory training will be administered for amnestic MCI.

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.

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

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.

All-Cause Mortality
Memory Training Kundalini Yoga and Meditation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Memory Training Kundalini Yoga and Meditation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Memory Training Kundalini Yoga and Meditation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/38 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Helen Lavretsky, M.D.
Organization: UCLA
Phone: 310-794-4619
EMail: hlavretsky@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Helen Lavretsky, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01983930     History of Changes
Other Study ID Numbers: 13-000821
First Submitted: October 30, 2013
First Posted: November 14, 2013
Results First Submitted: April 10, 2017
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018