Cognitive ChangeNCT06099405
Yoga Training and Retinal Vasculature
A study testing High-speed, Cognitive Challenge Yoga and Traditional yoga in people with Cognitive Change, run by University of Miami at 1 site in United States.
Trial summary
This study will compare the impact of a novel high-speed, cued yoga program to a standard yoga program on retinal microvasculature, cognition and neuromuscular function. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- High-speed, Cognitive Challenge Yoga and Traditional yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 15 May 2025
- 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;
- Montreal Cognitive Assessment (MoCA) > 23
- no memory loss complaints
Who cannot join
- uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;
- cerebrovascular disease;
- documented HIV infection or other immunodeficiency syndrome;
- any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;
- a history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;
- bilateral moderate or severe cataracts;
- refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 Diopters
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Neruomuscular Research and Active Aging
Coral Gables, Florida, 33147
About this study
Official title: The Impact of Yoga Training Protocols on Cognition, Aerobic, and Neuromuscular Performances, and Retinal Microvasculature and Microcirculation in Older Persons.
This study will compare the impact of a novel high-speed, cued yoga program to a standard yoga program on retinal microvasculature, cognition and neuromuscular function.
- Conditions
- Cognitive Change
- Being tested
- High-speed, Cognitive Challenge Yoga, Traditional yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-speed, Cognitive Challenge YogaBehavioural
Participants in this group will receive high-speed yoga with cuing 3 times per week for 24 consecutive weeks for a total of 72 training sessions of 1 hour duration. Subjects will move as quickly as possible from one pose to another.
Traditional yogaBehavioural
Participants will perform controlled speed Hatha yoga 3 times per week for 24 weeks for a total of 72 sessions of 1 hour duration.
| Study group | Role | What they receive |
|---|---|---|
| High-speed, Cognitive Challenge Yoga | Experimental | Participants in this group will receive high-speed yoga training for 24 consecutive weeks for a total of 72 training sessions. Receives: Behavioral: High-speed, Cognitive Challenge Yoga |
| Traditional Yoga | Active comparator | Participants will perform standard Hatha yoga with slow controlled speed movements for 24 consecutive weeks for a total of 72 training sessions. Receives: Behavioral: Traditional yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Retinal measured in microliters per second (ul/s)
Measurements of retinal blood flow (ul/s)
Measured: Baseline, 24 weeks
Changes in Retinal vascular biomarkers
vessel density in unitless fractal dimension.
Measured: Baseline, 24 weeks
Changes in the Hopkins Verbal Learning Test
The Hopkins Verbal Learning Test assesses immediate recall, delayed recall, and delayed recognition. It is administered by reading 12 words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay) and identify the words from a 24-word list that is presented verbally. The word list includes words from the previous list, words related to the previous list, and words unrelated to the list. Units of measurement are points. The test has three recall trials of 12 words each scored from 0 (none remembered to 12 (all remembered). Therefore, there are 36 points available for the 3 trials. After 20-25 minutes the subject's delayed recall is tested as the subject is asked to recall the same list of words, scored 0-12. Then a retention trial using a list of 24 words (12 words from the previous list, 6 related words, and 6 unrelated words) is read. The subjects must identify if each word was on the previous list or not.
Measured: Baseline, 24 weeks
Changes in Executive Function
Changes in executive function age-corrected fluid cognition composite score measured by the Dimensional Change Card Sort test, the Flanker test, Picture Sequence Memory test, List Sorting test, and pattern comparison test of the NIH Toolbox Cognition Module. The units of measurement are points with higher scores indicating higher levels of functioning. Scores 70 or below indicates significant fluid cognitive impairment, scores around 85 indicate below average fluid cognitive ability, scores at or near 100 are considered average, scores around 115 are considered above-average fluid cognitive ability, and 130 and above indicate superior fluid cognitive ability (top 2% based on the national Toolbox normative data).
Measured: Baseline, 24 weeks
Changes in the Six-Minute Walk Test
The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a person walks, the better their cardiovascular condition. The units are meters.
Measured: Baseline, 24 weeks
Changes in the Timed Up and Go
Upon verbal cue, the subject stands up, walks around a cone placed three meters from the front edge of the chair, and then returns to a seated position as quickly as possible. Time is measured in seconds. The faster the person completes the test the better the dynamic balance.
Measured: Baseline, 24 weeks
Changes in One repetition Maximum Strength
A one-repetition maximum test measures the maximum load that an individual can lift only a single time throughout the full range of motion of the chest press and leg press exercises using proper form. All subjects' one repetition maximum values will be determined within four to five trials. The units of measure are kilograms. Testing is performed on computerized, pneumatic machines.
Measured: Baseline, 24 weeks
Changes in Neuromuscular Power Testing
Peak muscle power is then measured at eight relative intensities (40, 50, 60, 70, and 80% of one repetition maximum) on the computerized, pneumatic machines. For each repetition, the concentric phase is performed as fast as possible, and the eccentric phase lasts between 2 and 3 seconds. Power testing is done for the leg press and chest press and the unit of measurement is Watts.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Sep 2023
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- McKnight Brain Research Foundation
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
- Investigators
- Joseph F. Signorile, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099405
- Sponsor's protocol ID
- 20230735
- Status last verified
- May 2025
- First submitted
- 19 Oct 2023
- Last updated
- 30 May 2025
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Yoga Training Protocols on Cognition, Aerobic, and Neuromuscular Performances, and Retinal Microvasculature and Microcirculation in Older Persons.
- ClinicalTrials.gov ID
- NCT06099405
- Acronym / sponsor ID
- 20230735
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- McKnight Brain Research Foundation
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 25 Oct 2023 (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 study will compare the impact of a novel high-speed, cued yoga program to a standard yoga program on retinal microvasculature, cognition and neuromuscular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-speed, Cognitive Challenge Yoga | Experimental | Behavioral: High-speed, Cognitive Challenge YogaParticipants in this group will receive high-speed yoga training for 24 consecutive weeks for a total of 72 training sessions. |
| Traditional Yoga | Active comparator | Behavioral: Traditional yogaParticipants will perform standard Hatha yoga with slow controlled speed movements for 24 consecutive weeks for a total of 72 training sessions. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60-90 years of age;
- Montreal Cognitive Assessment (MoCA) > 23
- no memory loss complaints
Key exclusion criteria (7 listed)
- uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;
- cerebrovascular disease;
- documented HIV infection or other immunodeficiency syndrome;
- any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;
- a history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;
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 |
|---|---|---|
| High-speed, Cognitive Challenge YogaParticipants in this group will receive high-speed yoga with cuing 3 times per week for 24 consecutive weeks for a total of 72 training sessions of 1 hour duration. Subjects will move as quickly as possible from one pose to another. | Behavioural | High-speed, Cognitive Challenge Yoga |
| Traditional yogaParticipants will perform controlled speed Hatha yoga 3 times per week for 24 weeks for a total of 72 sessions of 1 hour duration. | Behavioural | Traditional Yoga |
Primary outcome
Changes in Retinal measured in microliters per second (ul/s)
Time frame: Baseline, 24 weeks
Measurements of retinal blood flow (ul/s)
Changes in Retinal vascular biomarkers
Time frame: Baseline, 24 weeks
vessel density in unitless fractal dimension.
Changes in the Hopkins Verbal Learning Test
Time frame: Baseline, 24 weeks
The Hopkins Verbal Learning Test assesses immediate recall, delayed recall, and delayed recognition. It is administered by reading 12 words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay) and identify the words from a 24-word list that is presented verbally. The word list includes words from the previous list, words related to the previous list, and words unrelated to the list. Units of measurement are points. The test has three recall trials of 12 words each scored from 0 (none remembered to 12 (all remembered). Therefore, there are 36 points available for the 3 trials. After 20-25 minutes the subject's delayed recall is tested as the subject is asked to recall the same list of words, scored 0-12. Then a retention trial using a list of 24 words (12 words from the previous list, 6 related words, and 6 unrelated words) is read. The subjects must identify if each word was on the previous list or not.
Changes in Executive Function
Time frame: Baseline, 24 weeks
Changes in executive function age-corrected fluid cognition composite score measured by the Dimensional Change Card Sort test, the Flanker test, Picture Sequence Memory test, List Sorting test, and pattern comparison test of the NIH Toolbox Cognition Module. The units of measurement are points with higher scores indicating higher levels of functioning. Scores 70 or below indicates significant fluid cognitive impairment, scores around 85 indicate below average fluid cognitive ability, scores at or near 100 are considered average, scores around 115 are considered above-average fluid cognitive ability, and 130 and above indicate superior fluid cognitive ability (top 2% based on the national Toolbox normative data).
Changes in the Six-Minute Walk Test
Time frame: Baseline, 24 weeks
The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a person walks, the better their cardiovascular condition. The units are meters.
Changes in the Timed Up and Go
Time frame: Baseline, 24 weeks
Upon verbal cue, the subject stands up, walks around a cone placed three meters from the front edge of the chair, and then returns to a seated position as quickly as possible. Time is measured in seconds. The faster the person completes the test the better the dynamic balance.
Changes in One repetition Maximum Strength
Time frame: Baseline, 24 weeks
A one-repetition maximum test measures the maximum load that an individual can lift only a single time throughout the full range of motion of the chest press and leg press exercises using proper form. All subjects' one repetition maximum values will be determined within four to five trials. The units of measure are kilograms. Testing is performed on computerized, pneumatic machines.
Changes in Neuromuscular Power Testing
Time frame: Baseline, 24 weeks
Peak muscle power is then measured at eight relative intensities (40, 50, 60, 70, and 80% of one repetition maximum) on the computerized, pneumatic machines. For each repetition, the concentric phase is performed as fast as possible, and the eccentric phase lasts between 2 and 3 seconds. Power testing is done for the leg press and chest press and the unit of measurement is Watts.
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 30 May 2025.
- 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 F. Signorile, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-speed, Cognitive Challenge Yoga and Traditional yoga in people with Cognitive Change, run by University of Miami at 1 site 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 3 inclusion and 7 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 30 May 2025. 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 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?
Changes in Retinal measured in microliters per second (ul/s) (time frame: Baseline, 24 weeks). The study lists 8 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 30 May 2025.