Educational ControlNCT04022707
High Speed Circuit Training and Cognition
A study testing High-speed circuit resistance training in people with Educational Control and Resistance Training, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this research study is to see if a weight training program can make a positive change in participant fitness as measured by the ability to use oxygen and help the participant remember things. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Control, Resistance Training
- What is being tested?
- High-speed circuit resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2019to 30 Apr 2020
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 60 and 85 years of age (inclusive)
- Ability to provide informed consent
- No medical contraindication to participation in an exercise program including unstable or active untreated major medical illness (i.e., cardiovascular disease, neurological or neuromuscular diseases, stroke, cancer, etc.).
Who cannot join
- Existing muscle-skeletal injury
- Mini-mental score <18
- Enrolled in another exercise program
- Unstable or active major medical illness
- Answer "Yes" to any questions on the Elder PAR-Q
- Pregnancy
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: The Impact of Circuit Resistance Training on Cognition and Estimated Maximal Oxygen Consumption in Older Adults.
The purpose of this research study is to see if a weight training program can make a positive change in participant fitness as measured by the ability to use oxygen and help the participant remember things.
Read the detailed description
The purpose of this research study is to see if a weight training program can make a positive change in cardiac fitness, that is a person's ability to use oxygen; and, if the program can help a person's memory, as measured by some standard tests. The researchers will also ask the participant to attend two sessions with researchers at the Bascom-Palmer Eye Institute so they can take pictures of the participants' eyes to see how training changes the number of blood vessels. This can be used by doctors and other clinicians to evaluate improvements blood flow to the brain due to training.
- Conditions
- Educational Control, Resistance Training
- Being tested
- High-speed circuit resistance training, Educational control
- Keywords
- Elderly, Circuit training, Cognitive ability, Cardiovascular condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-speed circuit resistance trainingOther
Also called High-velocity circuit training
The program will include three circuits of 11 exercises that target the upper and lower body. Training will gradually increase over the first three week from 1 to 3 circuits.
Educational controlOther
Also called Control
Lectures on health and fitness
| Study group | Role | What they receive |
|---|---|---|
| High-Velocity Resistance Circuttraining (HVRCT) | Experimental | The participants will perform three circuits of 11 exercises that target the upper and lower body. Training will gradually increase over the first three weeks from 1 to 3 circuits. Receives: Other: High-speed circuit resistance training; Other: Educational control |
| Educational Control (CON) | Experimental | A supervised program will be provided to the participants that includes lectures on health and fitness. Receives: Other: High-speed circuit resistance training; Other: Educational control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cognition due to training
The MoCA will be used to detect mild cognitive impairment in the participants. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: Baseline, Week 14
Submaximal cycle ergometer test to measure aerobic capacity
The Young Men's Club of America (YMCA) cycle ergometer test will be used to compute aerobic capacity using heart rate(HR). Predicted oxygen consumption will be computed using the HR of the last two consecutive workloads performed and the maximum workload. A maximal oxygen consumption of 36 milliliters per kilogram body weight per minute and above is considered excellent for men, while 30 milliliters per kilogram body weight per minute is considered excellent for women.
Measured: Baseline, Week 14
Change in episodic memory
The National Institutes of Health (NIH) Toolbox: Picture Sequence Memory Test measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen. Participants are given credit for each adjacent pair of pictures they correctly place (i.e., if pictures in locations 7 and 8 are placed in that order and adjacent to each other anywhere, such as slots 1 and 2, one point is awarded), up to the maximum value for the sequence, which is one less than the sequence length or 17.
Measured: Baseline, Week 14
Change in attention and inhibitory control
The NIH Toolbox Flanker test measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. This computed score ranges from 0-10, but if the score is less than 4, it indicates that the participant did not score high enough in accuracy (80 percent correct or less) to receive a reaction time score.
Measured: Baseline, Week 14
Change in working memory
The NIH Toolbox List Sorting test measures working memory. Participant recalls and sequences different visually and orally presented stimuli. List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26.
Measured: Baseline, Week 14
Change in speed of cognitive processing
The 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. The participant's raw score is the number of items answered correctly in 85 seconds of response time, with a range of 0-130.
Measured: Baseline, Week 14
Changes in the power muscles can produce
The participants will stand up and down 3 times with a thin string attached to the participant's belt. A total of five attempts will be performed by each participant, and the highest power output will be selected for use in the analysis.
Measured: Baseline, Week 14
Change in retinal microvascular density as a marker of cortical changes
Retinal microvascular density will be assessed using the Retinal Function Imager (RFI) scan protocol and Optical Coherence Tomography Angiography (OCTA). Pictures will be taken of the subject's retina as they look into a special self-contained camera system.
Measured: Baseline, Week 14
Secondary outcomes (2)
Changes in body fat-free mass
Fat-free mass will be measured using a Tanita BC-418 bioelectrical impedance scale.
Measured: Baseline, Week 14
Changes in body weight
Body weight will be measured on an electronic scale
Measured: Baseline, Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Aug 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ControlStudies 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 High-Speed Resistance training and educational control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT04022707
- Sponsor's protocol ID
- 20190518
- Status last verified
- May 2020
- First submitted
- 10 Jul 2019
- Last updated
- 18 May 2020
- 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 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Circuit Resistance Training on Cognition and Estimated Maximal Oxygen Consumption in Older Adults.
- ClinicalTrials.gov ID
- NCT04022707
- Acronym / sponsor ID
- 20190518
- Conditions
- Educational Control, Resistance Training
- Keywords
- Elderly, Circuit training, Cognitive ability, Cardiovascular condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 17 Jul 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.
The purpose of this research study is to see if a weight training program can make a positive change in participant fitness as measured by the ability to use oxygen and help the participant remember things.
Detailed description
The purpose of this research study is to see if a weight training program can make a positive change in cardiac fitness, that is a person's ability to use oxygen; and, if the program can help a person's memory, as measured by some standard tests. The researchers will also ask the participant to attend two sessions with researchers at the Bascom-Palmer Eye Institute so they can take pictures of the participants' eyes to see how training changes the number of blood vessels. This can be used by doctors and other clinicians to evaluate improvements blood flow to the brain due to training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of High-Speed Resistance training and educational control
| Arm | Type | Receives |
|---|---|---|
| High-Velocity Resistance Circuttraining (HVRCT) | Experimental | Other: High-speed circuit resistance training, Other: Educational controlThe participants will perform three circuits of 11 exercises that target the upper and lower body. Training will gradually increase over the first three weeks from 1 to 3 circuits. |
| Educational Control (CON) | Experimental | Other: High-speed circuit resistance training, Other: Educational controlA supervised program will be provided to the participants that includes lectures on health and fitness. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women between 60 and 85 years of age (inclusive)
- Ability to provide informed consent
- No medical contraindication to participation in an exercise program including unstable or active untreated major medical illness (i.e., cardiovascular disease, neurological or neuromuscular diseases, stroke, cancer, etc.).
Key exclusion criteria (6 listed)
- Existing muscle-skeletal injury
- Mini-mental score <18
- Enrolled in another exercise program
- Unstable or active major medical illness
- Answer "Yes" to any questions on the Elder PAR-Q
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 trainingAlso: High-velocity circuit trainingThe program will include three circuits of 11 exercises that target the upper and lower body. Training will gradually increase over the first three week from 1 to 3 circuits. | Other | Educational Control (CON), High-Velocity Resistance Circuttraining (HVRCT) |
| Educational controlAlso: ControlLectures on health and fitness | Other | Educational Control (CON), High-Velocity Resistance Circuttraining (HVRCT) |
Primary outcome
Changes in Cognition due to training
Time frame: Baseline, Week 14
The MoCA will be used to detect mild cognitive impairment in the participants. The total possible score is 30 points; a score of 26 or above is considered normal.
Submaximal cycle ergometer test to measure aerobic capacity
Time frame: Baseline, Week 14
The Young Men's Club of America (YMCA) cycle ergometer test will be used to compute aerobic capacity using heart rate(HR). Predicted oxygen consumption will be computed using the HR of the last two consecutive workloads performed and the maximum workload. A maximal oxygen consumption of 36 milliliters per kilogram body weight per minute and above is considered excellent for men, while 30 milliliters per kilogram body weight per minute is considered excellent for women.
Change in episodic memory
Time frame: Baseline, Week 14
The National Institutes of Health (NIH) Toolbox: Picture Sequence Memory Test measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen. Participants are given credit for each adjacent pair of pictures they correctly place (i.e., if pictures in locations 7 and 8 are placed in that order and adjacent to each other anywhere, such as slots 1 and 2, one point is awarded), up to the maximum value for the sequence, which is one less than the sequence length or 17.
Change in attention and inhibitory control
Time frame: Baseline, Week 14
The NIH Toolbox Flanker test measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. This computed score ranges from 0-10, but if the score is less than 4, it indicates that the participant did not score high enough in accuracy (80 percent correct or less) to receive a reaction time score.
Change in working memory
Time frame: Baseline, Week 14
The NIH Toolbox List Sorting test measures working memory. Participant recalls and sequences different visually and orally presented stimuli. List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26.
Change in speed of cognitive processing
Time frame: Baseline, Week 14
The 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. The participant's raw score is the number of items answered correctly in 85 seconds of response time, with a range of 0-130.
Changes in the power muscles can produce
Time frame: Baseline, Week 14
The participants will stand up and down 3 times with a thin string attached to the participant's belt. A total of five attempts will be performed by each participant, and the highest power output will be selected for use in the analysis.
Change in retinal microvascular density as a marker of cortical changes
Time frame: Baseline, Week 14
Retinal microvascular density will be assessed using the Retinal Function Imager (RFI) scan protocol and Optical Coherence Tomography Angiography (OCTA). Pictures will be taken of the subject's retina as they look into a special self-contained camera system.
2 secondary outcomes
Changes in body fat-free mass
Time frame: Baseline, Week 14
Changes in body weight
Time frame: Baseline, Week 14
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 18 May 2020.
- 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 High-speed circuit resistance training in people with Educational Control and Resistance Training, 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 3 inclusion and 6 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 18 May 2020. 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?
Changes in Cognition due to training (time frame: Baseline, Week 14). 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 18 May 2020.