Mild Cognitive Impairment
Conditions
Keywords
Memory impairment, Meditation, Yoga, memory training, Mild cognitive impairment, MCI, geriatric, fMRI
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.
Interventions
BEHAVIORALKundalini 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.
BEHAVIORALMemory 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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale | 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) | 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 | Baseline and week 12 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHelen Lavretsky, MD, MS
UCLA Semel Institute
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.
Participants by arm
| Arm | Count |
|---|---|
| Memory Training 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. | 41 |
| Kundalini Yoga and Meditation 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. | 38 |
| Total | 79 |
Baseline characteristics
| Characteristic | Memory Training | Kundalini Yoga and Meditation | Total |
|---|---|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 8.7 | 67.6 years STANDARD_DEVIATION 8 | 67.9 years STANDARD_DEVIATION 8.4 |
| Race/Ethnicity, Customized Caucasian | 30 Participants | 24 Participants | 54 Participants |
| Race/Ethnicity, Customized Non-Caucasian | 11 Participants | 14 Participants | 25 Participants |
| Region of Enrollment United States | 41 Participants | 38 Participants | 79 Participants |
| Sex: Female, Male Female | 27 Participants | 25 Participants | 52 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 0 / 41 | 0 / 38 |
| serious Total, serious adverse events | 0 / 41 | 0 / 38 |
Outcome results
Primary
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.
Time frame: At baseline and at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Memory Training | Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score | Baseline | 26.02 units on a scale | Standard Deviation 5.42 |
| Memory Training | Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score | 6 Months | 27.96 units on a scale | Standard Deviation 5.44 |
| Kundalini Yoga and Meditation | Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score | Baseline | 25.76 units on a scale | Standard Deviation 6.2 |
| Kundalini Yoga and Meditation | Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score | 6 Months | 28.81 units on a scale | Standard Deviation 6.52 |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Memory Training | Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity | pregenual anterior cingulate cortex (ACC) p-value | 0.011 p-value |
| Memory Training | Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity | frontal medial cortex (FMC) p-value | 0.035 p-value |
| Kundalini Yoga and Meditation | Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity | pregenual anterior cingulate cortex (ACC) p-value | 0.001 p-value |
| Kundalini Yoga and Meditation | Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity | frontal medial cortex (FMC) p-value | 0.001 p-value |
Secondary
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).
Time frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 24
Population: Data were not collected.
Secondary
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.
Time frame: Baseline and Week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Memory Training | Geriatric Depression Scale (GDS) | Baseline | 5.7 units on a scale | Standard Deviation 5.6 |
| Memory Training | Geriatric Depression Scale (GDS) | Week 24 | 3.2 units on a scale | Standard Deviation 2.5 |
| Kundalini Yoga and Meditation | Geriatric Depression Scale (GDS) | Baseline | 7.5 units on a scale | Standard Deviation 5.1 |
| Kundalini Yoga and Meditation | Geriatric Depression Scale (GDS) | Week 24 | 3.9 units on a scale | Standard Deviation 2.5 |