NCT05513521

Brief Summary

The investigators propose to compare the effects of a 12-week load resistance training program to a velocity resistance training program on ultrasound measures of quadriceps muscle quality in a healthy, older adult population. As secondary measures, The investigators propose to compare the effects of these exercise programs on maximal strength, power, and functional movements such as the chair sit-to-stand and gait speed. Further, The investigators will evaluate the impact of each protocol on cognitive function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

January 4, 2023

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

August 22, 2022

Last Update Submit

December 30, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Five-time sit-to-stand

    The participant will sit with their arms folded across their chest and their back against the chair. On verbal command, the participant will stand up and sit down 5 times as quickly as possible. Timing begins at "Go" and ends when the buttocks touches the chair after the 5th repetition. One practice and two testing trials will be performed.

    5 minutes

  • 10-meter walk

    The participants will be asked to walk as quickly as possible in a straight line on a 10-m course marked at 0, 2, 8 and 10 m. On verbal command, participants will start on the 0-m mark and stop when they cross the 10-m mark. The total time to ambulate from the 2-m mark to the 8-m mark (6 m total) will be timed to the hundredth of a second. Two trials will be performed, and the average will be documented in m·s-1. One-minute recoveries will be provided between trials.

    5 minutes

  • One-repetition maximum (1RM) testing

    One-repetition maximum (1RM) strength testing will include leg press and chest press. After a warm-up, the subject do 10 repetitions a low resistance. The test will begin using a weight near the predicted maximum. The weight will then be increased or decreased depending on the subject's ability to perform the repetition using correct technique.

    10 minutes

  • Home Sleep Testing

    Study participants will have a home sleep study using the NoxA1 system that allows for monitoring of sleep (i.e., EEG) along with respiratory effort and oxygen saturation. The goal of the home sleep study is to exclude other respiratory-related sleep disorders, such as central sleep apnea and Cheyne-Stokes breathing, and efficiently characterize OSA severity. These sleep assessments are routinely done in clinical practice and will be conducted by the participant at home using self-applied portable monitors that are powered by one AA battery. This will only be worn for one night and instruction on setup will be given at the laboratory with a take-home packet for setup.

    8 hours

  • Actigraphy

    An actigraph, which measures activity levels, will be worn on the wrist for seven consecutive 24-hour periods, to collect data on habitual sleep duration. Wrist actigraphy is a technique for measuring movement over an extended recording period (days to weeks). Data garnered from wrist actigraphy will be used to derive variables such as habitual total sleep time, number and duration of awakenings per night, and napping behavior.

    168 hours

Secondary Outcomes (8)

  • Dimensional Card Sort (DCCS)

    5 minutes

  • Flanker test

    5 minutes

  • Picture Sequence Memory Test (PSMT)

    5 minutes

  • List Sorting Test

    5 minutes

  • Pattern Comparison Test

    5 minutes

  • +3 more secondary outcomes

Study Arms (2)

High-velocity interval training

EXPERIMENTAL

Subjects will be provided high-speed, low-load training to target improvements in velocity.

Other: High-velocity interval training

Resistance training

EXPERIMENTAL

Subjects will be provided low-speed, high-load training to target improvements in velocity

Other: Resistance training

Interventions

For the velocity training protocol, the 11 exercises will be completed at 40% of their 1RM. In the first three weeks of training, the loading volume will be increased gradually. During week one participants will complete one set of each exercise. Week two will consist of two sets, and weeks 3-12, three sets. Keiser pneumatic resistance machines are interfaced with a laboratory computer, which allows the transfer and analysis of data including force, velocity, and power.

High-velocity interval training

For the load training protocol, the 11 exercises will be completed at 79% of their 1RM. In the first three weeks of training, the loading volume will be increased gradually. During week one participants will complete one set of each exercise. Week two will consist of two sets, and weeks 3-12, three sets. Keiser pneumatic resistance machines are interfaced with a laboratory computer, which allows the transfer and analysis of data including force, velocity, and power.

Resistance training

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Montreal Cognitive Assessment (MOCA) \> 23 and no memory loss complaints.

You may not qualify if:

  • Any uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program; Any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, system lupus erythematosus, or other serious concomitant medical illness; Unresolved injury or surgery to the quadricep muscles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Neruomuscular Research and Active Aging

Coral Gables, Florida, 33147, United States

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor 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
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will not know intervention group membership.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Compare velocity-based interval resistance training to load-based resistance training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

August 18, 2022

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

January 4, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations