Kundalini Yoga & Healthy Neurological Aging

January 21, 2021 updated by: Soham Rej MD, MSc, Lady Davis Institute

Yoga and Brain Aging

This randomized-control trial pilot study investigates the potential neuroprotective effects of mindfulness-based interventions in older adults. In this study, the researchers examine the effects of Kundalini yoga on neurotypical brain aging with a focus on volumetric changes in the bilateral hippocampi and posterior cingulate cortex. 14 healthy, meditation-naïve participants (ages 60 to 80) were recruited. Half were randomly assigned to the Kundalini yoga group and half to the psychoeducation group. Overall, three participants withdrew from the study. The yoga intervention lasted for 12 weeks and the psychoeducation intervention lasted for 10 weeks. Structural and functional Magnetic Resonance Imaging (MRI) data were obtained at baseline and 12-week follow-up. The researchers will focus on analyzing structural MRI data, examining gray matter volume within a priori regions of interest (bilateral hippocampi and posterior cingulate cortex). Results from this pilot study are intended to provide effect-size estimates for future studies that would confirm the effects of Kundalini yoga on neurological aging. Researchers predict participation in the Kundalini yoga intervention, compared to the psychoeducation control condition, will result in a greater increase in gray matter volume of the bilateral hippocampi and posterior cingulate cortex from pre- to post-intervention. If the results are positive, this would provide initial neurobiological support for Kundalini yoga as a potential means to mitigate the effects of neurological aging and as a preventive measure for Alzheimer's disease and dementia, which could be assessed in future confirmatory clinical trials.

Study Overview

Status

Completed

Conditions

Detailed Description

Recruitment:

Participants were recruited from the Douglas Hospital as well as from the broader community through the use of an advertisement in The Gazzette and Le Devoir newspapers. Participants were pre-screened to ensure they were eligible for the study based on the inclusion and exclusion criteria. This screening process included a cognitive assessment as well as having participants lie in a mock scanner to assess their level of comfort and ability to complete the neuroimaging scans required for the study. If anyone was unable to comfortably lie in the mock scanner, then they were still given the option to participate in the program, but not as a research participant. A total of 14 participants were recruited for the study.

Intervention Groups:

Participants were evenly and randomly assigned to one of two groups. One group was the Kundalini yoga group while the other was a psychoeducation program (which acted as the control group). All seven participants in the Kundalini yoga group completed the study while only four participants in the psychoeducation group completed the study (i.e. three participants withdrew from the study). Participants were between the ages of 60 to 80 years old with no prior meditation experience and were relatively healthy with a baseline Mini-Mental State Examination score of 28-30. Participants were matched across groups for gender, age, and years of education. The study lasted about 12 weeks for participants in the Kundalini yoga group and about 10 weeks for those in the control group. The discrepancy in program length was the result of scheduling complications. Each condition had weekly, two-hour, group-based sessions that were led by a trained interventionist. The Kundalini yoga group exercises were customized for participants to ensure safety and are a mixture of postures, breathing exercises, and meditation. Additionally, participants were encouraged to do practice exercises at-home for half an hour a day. They were asked to report on the extent of their at-home practices. The control group consisted of a psychoeducation program where participants were taught about memory and healthy aging. Participants in this group were also encouraged to do at home tasks for about half an hour a day.

Data Collection:

Structural and functional MRI data were obtained both before and after participating in the intervention. The order of scanning was randomized and counterbalanced within and across subjects. Overall, scanning lasted about one hour in duration.

During the structural scan, participants were asked to lie down for 10 minutes. There were no images presented on the screen during this time. For the resting-state functional scan, participants were asked to look at a fixation cross presented on the screen while trying to relax.

Acquisition Parameters of both Structural and Functional Scanning:

Structural

  • Orientation: Coronal
  • Phase enc. dir.: R>>L
  • # of slices: 320
  • FoV: 206 mm IS x 320 RL
  • Slice thickness:$$0.64mm isotropic
  • TR: 2500ms
  • TE: 198ms
  • PAT mode: GRAPPA
  • Accel. factor: 2
  • Ref. lines PE: 24
  • Band width: 710 Hz/Px
  • Echo spacing: 4ms
  • Scan time: 10:02 minutes
  • Coil elements:$$HEA;HEP

Resting-State

  • # of slices: 32
  • Orientation: Transversal ACBPC
  • Phase enc. dir.:A>>P
  • FoV: 128 mm IS x 256 mm AP
  • Motion correction = off
  • Slice thickness: 4mm
  • TR: 2000ms
  • TE: 30ms
  • Flip angle: 90°
  • PAT mode: none
  • Band width: 2442 Hz/Px
  • Echo spacing: 0.47ms
  • GLM statistics = off
  • # of measurements: 150
  • Scan time: 5:04 minutes
  • Coil elements: HEA;HEP

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montréal, Quebec, Canada, H4H 1R3
        • Douglas Mental Health University Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neurologically Healthy
  • Between ages 60-80 years old
  • Little to no meditation experience

Exclusion Criteria:

  • Any neurological or psychiatric disorder or a family history of such disorders
  • Uncomfortable or unable to undergo MRI scanning
  • Diabetes, or a cardiovascular or respiratory illness
  • Regular alcohol or tobacco consumption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kundalini Yoga
The Kundalini yoga intervention is a mixture of basic yoga, breathing exercises and meditation. Participants were also asked to do at-home practice for half an hour daily.
Participants met once a week for two hours for 12 weeks total. The Kundalini yoga intervention is a mixture of basic yoga, breathing exercises, and meditation. Participants were also asked to do at-home practice for half an hour daily.
Active Comparator: Psychoeducation
The psychoeducation group consisted of teaching participants about healthy aging. Participants were asked to do at-home practice for half an hour daily
Participants met once a week for two hours for 10 weeks total. The psychoeducation group acted as our control group and consisted of teaching participants about healthy aging. Participants were asked to do at-home practice for half an hour daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Gray Matter Volume in Bilateral Hippocampi and Posterior Cingulate Cortex at 10-12 weeks
Time Frame: Structural neuroimaging scans were taken at baseline (0 weeks) and post-intervention (10 to 12 weeks, 10 weeks for the control group and 12 weeks for the Kundalini Yoga intervention group).
Participants were placed in an MRI machine to conduct structural imaging scans to determine the potential impact of the intervention on gray matter volume in bilateral hippocampi and posterior cingulate cortex of participants after the intervention (10-12 weeks from baseline; 10 weeks for the psychoeducation control group and 12 weeks for the Kundalini yoga intervention. Discrepancy in intervention durations was a result of scheduling conflicts).Voxel-Based Morphometry was used to analyze structural images.
Structural neuroimaging scans were taken at baseline (0 weeks) and post-intervention (10 to 12 weeks, 10 weeks for the control group and 12 weeks for the Kundalini Yoga intervention group).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Functional Connectivity in the Posterior Cingulate Cortex at 10-12-weeks.
Time Frame: Functional neuroimaging scans were taken at baseline (0 weeks) and post-intervention (10-12 weeks; 10 weeks for the psychoeducation control group and 12 weeks for the Kundalini yoga intervention).
Participants were placed in an fMRI machine to conduct resting-state functional imaging scans (each resting state acquisition lasted 5:04 minutes) to determine the potential impact of the intervention on functional connectivity in the posterior cingulate cortex of participants after the intervention (10-12 weeks from baseline; 10 weeks for the psychoeducation control group and 12 weeks for the Kundalini yoga intervention. Discrepancy in intervention durations was a result of scheduling conflicts).
Functional neuroimaging scans were taken at baseline (0 weeks) and post-intervention (10-12 weeks; 10 weeks for the psychoeducation control group and 12 weeks for the Kundalini yoga intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Soham Rej, MD, MSc, Lady Davis Research Institue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2017

Primary Completion (Actual)

April 24, 2018

Study Completion (Actual)

April 24, 2018

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IUSMD-16-55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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