NCT05760066

Brief Summary

The goal of this clinical trial is to compare the effects of resistance training (RT) preconditioning vs no training on disuse-induced atrophy and post-disuse resistance training in young healthy individuals. The main questions it aims to answer are:

  • To determine if performing RT prior to a period of disuse enhances the regain of strength, skeletal muscle size, and skeletal muscle quality while performing RT after a period of disuse.
  • To determine if performing RT prior to a period of disuse dampens the maladaptive effects of disuse on muscle size, muscle quality, and strength.
  • To determine the anabolic and proteolytic mechanisms underpinning the observed outcomes. Participants will:
  • Perform either 6 weeks of resistance training or maintain an untrained lifestyle
  • Perform 2 weeks of limb immobilization induced disuse of a randomized leg
  • Perform 6 weeks of resistance training

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Status
unknown

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

First Submitted

Initial submission to the registry

January 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

January 23, 2023

Last Update Submit

February 26, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in vastus lateralis fiber cross-sectional area

    Upon the procurement and analysis of muscle from the vastus lateralis of participants, histological techniques will be used to assess fiber cross-sectional area of muscle fibers

    Through completion of study, 16 weeks

  • Change in quadriceps strength via 3 repetition maximum testing

    Strength of the quadriceps will be assessed via 3-repetition maximum testing of select exercises (leg press, leg extension, hex-bar deadlift)

    Through completion of study, 16 weeks

  • Change in quadriceps strength via isokinetic dynamometry

    Strength of the quadriceps will be assessed via isokinetic dynamometry

    Through completion of study, 16 weeks

Secondary Outcomes (4)

  • Change in protein expression of anabolic signaling proteins

    Through completion of study, 16 weeks

  • Change in protein expression of catabolic signaling proteins

    Through completion of study, 16 weeks

  • Change in activity of catabolic systems

    Through completion of study, 16 weeks

  • Gene expression at the mRNA level of atrophy-associated genes (atrogenes)

    Through completion of study, 16 weeks

Study Arms (2)

Resistance Training Preconditioning (PRECON)

EXPERIMENTAL

This group will perform: 1. 6 weeks of lower body focused resistance training 2. 2 weeks of locking brace-induced immobilization of a randomized leg 3. 6 weeks of lower body focused resistance training

Other: Resistance Training Preconditioning

Control (CTL)

ACTIVE COMPARATOR

This group will perform: 1. 6 weeks of activities of daily living (no training) 2. 2 weeks of locking brace-induced immobilization of a randomized leg 3. 6 weeks of lower body focused resistance training

Other: Control

Interventions

Resistance training prior to disuse-induced atrophy followed by another period of resistance training

Resistance Training Preconditioning (PRECON)
ControlOTHER

Activities of daily living prior to disuse-induced atrophy followed by a period of resistance training

Control (CTL)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-30
  • Free from medical implants in lower extremity that would interfere with low-dose radiation
  • Are not allergic to ultrasound gel or Lidocaine
  • Have no or minimal experience with resistance training (less than 1 training session/week for a 1 year period)

You may not qualify if:

  • Have been exposed to medically necessary radiation in the past 12 months other than dental x-rays
  • Have known overt cardiovascular or metabolic disease
  • Have a medical condition that would contraindicate participating in an exercise program or donating a skeletal muscle biopsy (e.g. blood clotting disorder, taking blood thinners, etc.)
  • Are undergoing medical treatment for a disease that would interfere physiologically or logistically with study outcomes and/or protocols (e.g. undergoing chemotherapy and/or radiation for cancer treatment)
  • Have consumed supplemental protein, creatine, and/or agents that affect hormone status (e.g. testosterone, growth hormone boosters, etc.) within the previous 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular Disorders, AtrophicMuscular Atrophy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Michael D Roberts, PhD

CONTACT

John M Michel, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2023

First Posted

March 8, 2023

Study Start

August 1, 2023

Primary Completion

December 31, 2023

Study Completion

August 1, 2024

Last Updated

March 8, 2023

Record last verified: 2023-02