Cognitive ChangeNCT05735353
Sleep, Diet, Exercise and Older Persons
A study testing High-Speed Circuit Resistance Training and High-Speed Multidirectional Yoga in people with Cognitive Change and Cognitive Decline, run by University of Miami at 1 site in United States.
Trial summary
To examine the impacts of a cognitive yoga program and circuit resistance training on cognitive and physical performance with nutrition and sleep as modulating factors in healthy, older adults. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Cognitive Decline
- What is being tested?
- High-Speed Circuit Resistance Training and High-Speed Multidirectional Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 30 Jul 2023
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment > 23
- No memory loss complaints
Who cannot join
- Uncontrolled cardiovascular or neuromuscular disease that prevents participation in a training program
- Musculoskeletal impairments or injury that may impact exercise participation
- Visual or hearing impairments
- Neurological disease
- Stroke
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: High-Speed Circuit Resistance Training vs. High-Speed Multidirectional Yoga on Changes in Cognition in Healthy Older Adults.
To examine the impacts of a cognitive yoga program and circuit resistance training on cognitive and physical performance with nutrition and sleep as modulating factors in healthy, older adults.
- Conditions
- Cognitive Change, Cognitive Decline
- Being tested
- High-Speed Circuit Resistance Training, High-Speed Multidirectional Yoga
- Keywords
- Circuit Resistance Training, Yoga, Cognition
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Speed Circuit Resistance TrainingBehavioural
three times per week; 45 minutes per session; 12-weeks
High-Speed Multidirectional YogaBehavioural
two times per week; 60 minutes per session; 12-weeks
| Study group | Role | What they receive |
|---|---|---|
| High-Speed Circuit Resistance Training Group | Experimental | Participants in this group will receive high-speed circuit resistance training for 12 consecutive weeks. Receives: Behavioral: High-Speed Circuit Resistance Training |
| High-Speed Multidirectional Yoga Group | Experimental | Participants in this group will receive high-speed multidirectional yoga for 12 consecutive weeks. Receives: Behavioral: High-Speed Multidirectional Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Executive Function
Changes in executive function composite score measured by the NIH Toolbox Cognition Module
Measured: Baseline, 16 weeks
Secondary outcomes (2)
Changes in Nutritional Status
Nutritional status will be assessed by the Nutritionist Pro (Axxya Systems, Redmond, WA), a nutrition analysis software that can be used for diet 24 hour recalls. Participants will be asked to recall food intake for one weekday and one weekend day.
Measured: Baseline, 16 weeks.
Changes in Sleep Quality as measured by the Pittsburg Sleep Quality Index
The Pittsburg Sleep Quality Index has seven component scores that are added to yield one global score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Measured: Baseline, 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start17 Jan 2023
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 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
- NCT05735353
- Sponsor's protocol ID
- 20221319
- Status last verified
- Apr 2023
- First submitted
- 12 Jan 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Speed Circuit Resistance Training vs. High-Speed Multidirectional Yoga on Changes in Cognition in Healthy Older Adults.
- ClinicalTrials.gov ID
- NCT05735353
- Acronym / sponsor ID
- 20221319
- Conditions
- Cognitive Change, Cognitive Decline
- Keywords
- Circuit Resistance Training, Yoga, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 21 Feb 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.
To examine the impacts of a cognitive yoga program and circuit resistance training on cognitive and physical performance with nutrition and sleep as modulating factors in healthy, older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Speed Circuit Resistance Training Group | Experimental | Behavioral: High-Speed Circuit Resistance TrainingParticipants in this group will receive high-speed circuit resistance training for 12 consecutive weeks. |
| High-Speed Multidirectional Yoga Group | Experimental | Behavioral: High-Speed Multidirectional YogaParticipants in this group will receive high-speed multidirectional yoga for 12 consecutive weeks. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Montreal Cognitive Assessment > 23
- No memory loss complaints
Key exclusion criteria (5 listed)
- Uncontrolled cardiovascular or neuromuscular disease that prevents participation in a training program
- Musculoskeletal impairments or injury that may impact exercise participation
- Visual or hearing impairments
- Neurological disease
- Stroke
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 Circuit Resistance Trainingthree times per week; 45 minutes per session; 12-weeks | Behavioural | High-Speed Circuit Resistance Training Group |
| High-Speed Multidirectional Yogatwo times per week; 60 minutes per session; 12-weeks | Behavioural | High-Speed Multidirectional Yoga Group |
Primary outcome
Changes in Executive Function
Time frame: Baseline, 16 weeks
Changes in executive function composite score measured by the NIH Toolbox Cognition Module
2 secondary outcomes
Changes in Nutritional Status
Time frame: Baseline, 16 weeks.
Changes in Sleep Quality as measured by the Pittsburg Sleep Quality Index
Time frame: Baseline, 16 weeks.
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 28 Sep 2023.
- 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
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 Circuit Resistance Training and High-Speed Multidirectional Yoga in people with Cognitive Change and Cognitive Decline, 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 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 28 Sep 2023. 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 Executive Function (time frame: Baseline, 16 weeks). 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 28 Sep 2023.