NCT04022707

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

July 10, 2019

Last Update Submit

May 15, 2020

Conditions

Keywords

ElderlyCircuit trainingCognitive abilityCardiovascular condition

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Changes in body fat-free mass

    Baseline, Week 14

  • Changes in body weight

    Baseline, Week 14

Study Arms (2)

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.

Other: High-speed circuit resistance trainingOther: Educational control

Educational Control (CON)

EXPERIMENTAL

A supervised program will be provided to the participants that includes lectures on health and fitness.

Other: High-speed circuit resistance trainingOther: Educational control

Interventions

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.

Also known as: High-velocity circuit training
Educational Control (CON)High-Velocity Resistance Circuttraining (HVRCT)

Lectures on health and fitness

Also known as: Control
Educational Control (CON)High-Velocity Resistance Circuttraining (HVRCT)

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Max Orovitz Laboratories

Coral Gables, Florida, 33146-2416, United States

Location

Laboratory of Neruomuscular Research and Active Aging

Coral Gables, Florida, 33147, United States

Location

Study Officials

  • Joseph Signorile, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Tests will not be performed by the investigators providing the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of High-Speed Resistance training and educational control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 17, 2019

Study Start

August 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations