Kundalini Yoga & Healthy Neurological Aging

NCT04726072 | Completed

• 1 other identifier: IUSMD-16-55
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurological Aging

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Gray Matter Volume in Bilateral Hippocampi and Posterior Cingulate Cortex at 10-12 weeks

  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 Outcomes (1)

• Change from Baseline Functional Connectivity in the Posterior Cingulate Cortex at 10-12-weeks.

  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).

Study Arms (2)

Kundalini Yoga

EXPERIMENTAL

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.

Behavioral: Kundalini Yoga

Psychoeducation

ACTIVE COMPARATOR

The psychoeducation group consisted of teaching participants about healthy aging. Participants were asked to do at-home practice for half an hour daily

Behavioral: Psychoeducation

Interventions

Kundalini Yoga BEHAVIORAL

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.

Kundalini Yoga

Psychoeducation BEHAVIORAL

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.

Psychoeducation

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Davis Institute: lead
• Kripalu Institute and the Mind and Life Institute: collaborator

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Study Officials

• Soham Rej, MD, MSc

  Lady Davis Research Institue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: Participants were randomly assigned to one of two groups for the duration of the study. One group was a Kundalini Yoga intervention while the other was a psychoeducation control group.

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 27, 2021
• Study Start: July 3, 2017
• Primary Completion: April 24, 2018
• Study Completion: April 24, 2018
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)