Neurological AgingNCT04726072
Kundalini Yoga & Healthy Neurological Aging
A study testing Kundalini Yoga and Psychoeducation in people with Neurological Aging, run by Lady Davis Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurological Aging
- What is being tested?
- Kundalini Yoga and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jul 2017to 24 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neurologically Healthy
- Between ages 60-80 years old
- Little to no meditation experience
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
About this study
Official title: 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.
Read the 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
- Conditions
- Neurological Aging
- Being tested
- Kundalini Yoga, Psychoeducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kundalini YogaBehavioural
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.
PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start3 Jul 2017
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kripalu Institute and the Mind and Life Institute
- Responsible party
- Principal investigator, Soham Rej MD, MSc, Lady Davis Institute
- Investigators
- Soham Rej, MD, MSc, Principal investigator, Lady Davis Research Institue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726072
- Sponsor's protocol ID
- IUSMD-16-55
- Status last verified
- Jan 2021
- First submitted
- 2 Dec 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga and Brain Aging
- ClinicalTrials.gov ID
- NCT04726072
- Acronym / sponsor ID
- IUSMD-16-55
- Conditions
- Neurological Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Kripalu Institute and the Mind and Life Institute
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kundalini Yoga | Experimental | Behavioral: Kundalini YogaThe 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. |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationThe psychoeducation group consisted of teaching participants about healthy aging. Participants were asked to do at-home practice for half an hour daily |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neurologically Healthy
- Between ages 60-80 years old
- Little to no meditation experience
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kundalini YogaParticipants 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. | Behavioural | Kundalini Yoga |
| PsychoeducationParticipants 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. | Behavioural | Psychoeducation |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soham Rej, MD, MSc principal investigator
Lady Davis Research Institue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kundalini Yoga and Psychoeducation in people with Neurological Aging, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.