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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04022707
Other study ID # 20190518
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date April 30, 2020

Study information

Verified date May 2020
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Educational control
Lectures on health and fitness

Locations

Country Name City State
United States Laboratory of Neruomuscular Research and Active Aging Coral Gables Florida
United States Max Orovitz Laboratories Coral Gables Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, Week 14
Primary 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. Baseline, Week 14
Primary 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. Baseline, Week 14
Primary 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. Baseline, Week 14
Primary 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. Baseline, Week 14
Primary 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. Baseline, Week 14
Primary 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. Baseline, Week 14
Primary 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. Baseline, Week 14
Secondary Changes in body fat-free mass Fat-free mass will be measured using a Tanita BC-418 bioelectrical impedance scale. Baseline, Week 14
Secondary Changes in body weight Body weight will be measured on an electronic scale Baseline, Week 14
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