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

• 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: University of California, Los Angeles
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Memory Training	Kundalini Yoga and Meditation	Total
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
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

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memory Training	Kundalini Yoga and Meditation
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
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

Outcome Measure Data

Analysis Population Description

Data were not collected.

Arm/Group Title	Memory Training	Kundalini Yoga and Meditation
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memory Training	Kundalini Yoga and Meditation
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memory Training	Kundalini Yoga and Meditation
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

Adverse Events

Time Frame	3 years
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Memory Training	Kundalini Yoga and Meditation
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	--/--	--/--
Serious Adverse Events
	Memory Training	Kundalini Yoga and Meditation
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/38 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Helen Lavretsky, M.D.
• Organization: UCLA
• Phone: 310-794-4619
• EMail: hlavretsky@mednet.ucla.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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