NCT05714813

Brief Summary

The purpose of this research study is to see if high-speed weight training performed in a circuit (using one machine after another) can improve participant heart and brain function, strength, and power in older persons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

Study Start

First participant enrolled

September 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

December 21, 2022

Last Update Submit

January 26, 2023

Conditions

Keywords

Circuit Resistance TrainingHigh-velocity TrainingRetinal MicrovasculatureCognitive Function

Outcome Measures

Primary Outcomes (1)

  • Change in retinal vessel density as measured by Optical Coherence Tomography Angiography (OCTA)

    OCTA uses a special camera system and software to measure the densities of the small vessels (microvasculature) of the retinal layers of the eye.

    Baseline, 24 weeks

Secondary Outcomes (12)

  • Change in Event Memory as measured by the Picture Sequence Memory Test

    Baseline, 24 weeks

  • Change in Information Sorting as measured by the NIH List Sorting Test

    Baseline, 24 weeks

  • Change in Reaction Time for a Mental Task as measured by the NIH Pattern Comparison Processing Speed Test

    Baseline, 24 weeks

  • Change in Dynamic Balance as measured by the Timed Up-and-Go test

    Baseline, 24 weeks

  • Change in the Ability to perform Daily Activities as measured by the Physical Performance Test

    Baseline, 24 weeks

  • +7 more secondary outcomes

Study Arms (2)

High-Speed Circuit Resistance Training Group

EXPERIMENTAL

Participants in this group will receive high-speed circuit resistance training 3 times a week for 24 consecutive weeks for a total of 72 training sessions.

Behavioral: High-Speed Circuit Resistance Training

Control Group

OTHER

Participants in this arm will receive two lectures on fitness, diet, or cognition each month for 24 weeks for a total of 12 lectures.

Behavioral: Lecture on Diet, Exercise and Cognition

Interventions

Performance of 24 weeks of high-speed concentric and low-speed eccentric lift across three circuits on eleven pneumatic machines. Each training session will be in person and will last between 45 minutes and one hour.

High-Speed Circuit Resistance Training Group

Lectures on diet, exercise, and cognition. Lectures will be provided in person or online and will last approximately one hour.

Control Group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age;
  • Montreal Cognitive Assessment (MoCA) \> 23
  • no memory loss complaints

You may not qualify if:

  • Uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;
  • Cerebrovascular disease;
  • Malignancy within the previous 5 years;
  • Documented HIV infection or other immunodeficiency syndrome;
  • Any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;
  • A history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;
  • Bilateral moderate or severe cataracts;
  • Refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 Diopters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratory of Neuromuscular Research and Active Aging

Coral Gables, Florida, 33146-2416, United States

Location

Laboratory of Neuromuscular Research and Active Aging

Coral Gables, Florida, 33147, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionCerebral Small Vessel Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joseph F Signorile, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 21, 2022

First Posted

February 6, 2023

Study Start

September 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

February 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations