Standard YogaNCT03799640
Multidirectional Yoga for Cognition
A study testing Standard Yoga and Multi-directional Yoga in people with Standard Yoga and Multi-directional Yoga, run by University of Miami at 2 sites in United States.
Trial summary
Older individuals, 60-90, will be provided regular or cognitively based yoga training. They will then be evaluated using standard cognitive testing devices. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Standard Yoga, Multi-directional Yoga, Educational Control
- What is being tested?
- Standard Yoga and Multi-directional Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2018to 15 Aug 2019
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-90 years of age
- Capable of walking 50 feet with or without a walking aid-
Who cannot join
- Regularly participating in yoga or other balance training program
- Currently participating in another exercise study
- Unable to commit to study duration
- Uncontrolled neuromuscular or cardiovascular disease that prevents participation in an exercise study
- Advised not to exercise by their physician
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Max Orovitz Laboratories
Coral Gables, Florida, 33146-2416
Laboratory of Neruomuscular Research and Active Aging
Coral Gables, Florida, 33147
About this study
Official title: Multidirectional Yoga Training to Improve in Healthy Older Participants
Older individuals, 60-90, will be provided regular or cognitively based yoga training. They will then be evaluated using standard cognitive testing devices.
Read the detailed description
Reductions in executive function are common with age. Along with these declines come reductions in simple functional patterns of daily living such as crossing a street, walking in a crowded area, or performing any functions that occurs in an open (changing) environment. This study will use a newly developed yoga program incorporating multi-directional movements, cognitive challenges and visuomotor disturbances to improve executive function and associated movements in persons over 60 years of age.
- Conditions
- Standard Yoga, Multi-directional Yoga, Educational Control
- Being tested
- Standard Yoga, Multi-directional Yoga, Educational Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard YogaOther
Yoga using standard poses and linear movements
Multi-directional YogaOther
The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses.
Educational ControlOther
Lectures on health and fitness
| Study group | Role | What they receive |
|---|---|---|
| Standard Yoga | Experimental | Yoga will be performed using linear forward and backward movements. Receives: Other: Multi-directional Yoga; Other: Educational Control |
| Multi-directional Yoga | Experimental | The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. . Receives: Other: Standard Yoga; Other: Educational Control |
| Educational Control | Experimental | Lectures on Health and Wellness Receives: Other: Standard Yoga; Other: Multi-directional Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Toolbox: Picture Sequence Memory Test
Measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen.
Measured: 5 minutes
NIH Toolbox Flanker test
Measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it.
Measured: 5 minutes
NIH Toolbox List Sorting test
Measures working memory. Participant recalls and sequences different visually and orally presented stimuli.
Measured: 5 minutes
NIH Toolbox Pattern Comparison Processing Speed test
Measures speed of processing. Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible. Items are simple so as to purely measure processing speed.
Measured: 5 minutes
Walking Executive Function Tests
Walking and responding to visual cues presented on a 60 inch monitor.
Measured: 10 minutes
Timed up-and-go
Rising from a chair, circumventing a cone and returning to the chair.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start5 Dec 2018
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Standard YogaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of Yoga Interventions
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
- Investigators
- Joseph Signorile, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799640
- Sponsor's protocol ID
- 20180704
- Status last verified
- Sep 2019
- First submitted
- 8 Jan 2019
- Last updated
- 10 Sep 2019
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidirectional Yoga Training to Improve in Healthy Older Participants
- ClinicalTrials.gov ID
- NCT03799640
- Acronym / sponsor ID
- 20180704
- Conditions
- Standard Yoga, Multi-directional Yoga, Educational Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 10 Jan 2019 (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.
Older individuals, 60-90, will be provided regular or cognitively based yoga training. They will then be evaluated using standard cognitive testing devices.
Detailed description
Reductions in executive function are common with age. Along with these declines come reductions in simple functional patterns of daily living such as crossing a street, walking in a crowded area, or performing any functions that occurs in an open (changing) environment. This study will use a newly developed yoga program incorporating multi-directional movements, cognitive challenges and visuomotor disturbances to improve executive function and associated movements in persons over 60 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Comparison of Yoga Interventions
| Arm | Type | Receives |
|---|---|---|
| Standard Yoga | Experimental | Other: Multi-directional Yoga, Other: Educational ControlYoga will be performed using linear forward and backward movements. |
| Multi-directional Yoga | Experimental | Other: Standard Yoga, Other: Educational ControlThe multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. . |
| Educational Control | Experimental | Other: Standard Yoga, Other: Multi-directional YogaLectures on Health and Wellness |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60-90 years of age
- Capable of walking 50 feet with or without a walking aid-
Key exclusion criteria (5 listed)
- Regularly participating in yoga or other balance training program
- Currently participating in another exercise study
- Unable to commit to study duration
- Uncontrolled neuromuscular or cardiovascular disease that prevents participation in an exercise study
- Advised not to exercise by their physician
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 |
|---|---|---|
| Standard YogaYoga using standard poses and linear movements | Other | Educational Control, Multi-directional Yoga |
| Multi-directional YogaThe multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. | Other | Educational Control, Standard Yoga |
| Educational ControlLectures on health and fitness | Other | Multi-directional Yoga, Standard Yoga |
Primary outcome
NIH Toolbox: Picture Sequence Memory Test
Time frame: 5 minutes
Measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen.
NIH Toolbox Flanker test
Time frame: 5 minutes
Measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it.
NIH Toolbox List Sorting test
Time frame: 5 minutes
Measures working memory. Participant recalls and sequences different visually and orally presented stimuli.
NIH Toolbox Pattern Comparison Processing Speed test
Time frame: 5 minutes
Measures speed of processing. Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible. Items are simple so as to purely measure processing speed.
Walking Executive Function Tests
Time frame: 10 minutes
Walking and responding to visual cues presented on a 60 inch monitor.
Timed up-and-go
Time frame: 5 minutes
Rising from a chair, circumventing a cone and returning to the chair.
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 10 Sep 2019.
- 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.
Joseph Signorile, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Yoga and Multi-directional Yoga in people with Standard Yoga and Multi-directional Yoga, run by University of Miami at 2 sites in United States.
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 2 inclusion and 5 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
NIH Toolbox: Picture Sequence Memory Test (time frame: 5 minutes). The study lists 6 primary outcomes in all. 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 10 Sep 2019.