- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04726072
Kundalini Yoga & Healthy Neurological Aging
Yoga and Brain Aging
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H4H 1R3
- Douglas Mental Health University Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Soham Rej, MD, MSc, Lady Davis Research Institue
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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