High Speed Circuit Training and Cognition

May 15, 2020 updated by: Joseph Signorile, University of Miami

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33147
        • Laboratory of Neruomuscular Research and Active Aging
      • Coral Gables, Florida, United States, 33146-2416
        • Max Orovitz Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women between 60 and 85 years of age (inclusive)
  2. Ability to provide informed consent
  3. 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.).

Exclusion Criteria:

  1. Existing muscle-skeletal injury
  2. Mini-mental score <18
  3. Enrolled in another exercise program
  4. Unstable or active major medical illness
  5. Answer "Yes" to any questions on the Elder PAR-Q
  6. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-Velocity Resistance Circuttraining (HVRCT)
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.
Other: High-speed circuit resistance 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.
Other Names:
  • High-velocity circuit training
Other: Educational control
Lectures on health and fitness
Other Names:
  • Control
Experimental: Educational Control (CON)
A supervised program will be provided to the participants that includes lectures on health and fitness.
Other: High-speed circuit resistance 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.
Other Names:
  • High-velocity circuit training
Other: Educational control
Lectures on health and fitness
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 14
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.
Baseline, Week 14
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.
Baseline, Week 14
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.
Baseline, Week 14
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.
Baseline, Week 14
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.
Baseline, Week 14
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.
Baseline, Week 14
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.
Baseline, Week 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in body fat-free mass
Time Frame: Baseline, Week 14
Fat-free mass will be measured using a Tanita BC-418 bioelectrical impedance scale.
Baseline, Week 14
Changes in body weight
Time Frame: Baseline, Week 14
Body weight will be measured on an electronic scale
Baseline, Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20190518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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