NCT01983930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

December 1, 2017

Enrollment Period

2.7 years

First QC Date

October 30, 2013

Results QC Date

April 10, 2017

Last Update Submit

December 14, 2017

Conditions

Keywords

Memory impairmentMeditationYogamemory trainingMild cognitive impairmentMCIgeriatricfMRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Clinical Global Impression Scale

    Baseline, weeks 2, 4, 6, 8, 10, 12, 24

  • Geriatric Depression Scale (GDS)

    Baseline and Week 24

  • Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity

    12 weeks

Study Arms (2)

Memory Training

ACTIVE COMPARATOR

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

Behavioral: Memory Training

Kundalini yoga and meditation

EXPERIMENTAL

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

Behavioral: Kundalini yoga and meditation

Interventions

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.

Kundalini yoga and meditation
Memory TrainingBEHAVIORAL

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.

Memory Training

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cognitive DysfunctionMemory Disorders

Interventions

MeditationCognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Helen Lavretsky, M.D.
Organization
UCLA

Study Officials

  • Helen Lavretsky, MD, MS

    UCLA Semel Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 14, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 23, 2018

Results First Posted

October 23, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations