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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Kundalini yoga and meditation
* Behavioral: Memory Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Memory Training<br>Group memory training will be administered for amnestic mild cognitive impairment (MCI) | Behavioral: Memory Training<br>* 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.<br>|
| Experimental: Kundalini yoga and meditation<br>Participants will engage in weekly yoga classes and daily 20 minute meditation | Behavioral: Kundalini yoga and meditation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, weeks 2, 4, 6, 8, 10, 12, 24 | 
| 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. | Baseline and Week 24 | 
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory impairment, Meditation, Yoga, memory training, Mild cognitive impairment, MCI, geriatric, fMRI