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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05760066
Other study ID # MDR0823
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date August 1, 2024

Study information

Verified date February 2023
Source Auburn University
Contact Michael D Roberts, PhD
Phone 334-844-1925
Email mdr0024@auburn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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: 1. Perform either 6 weeks of resistance training or maintain an untrained lifestyle 2. Perform 2 weeks of limb immobilization induced disuse of a randomized leg 3. Perform 6 weeks of resistance training Researchers will compare the resistance training preconditioning condition vs the non-trained condition to see if resistance training prior to a period of disuse is beneficial during the disuse period and in the return to training period on skeletal muscle size, strength, and underpinning molecular markers.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date August 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Resistance Training Preconditioning
Resistance training prior to disuse-induced atrophy followed by another period of resistance training
Control
Activities of daily living prior to disuse-induced atrophy followed by a period of resistance training

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Auburn University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Change in quadriceps strength via isokinetic dynamometry Strength of the quadriceps will be assessed via isokinetic dynamometry Through completion of study, 16 weeks
Secondary Change in protein expression of anabolic signaling proteins Western blotting will be performed and quantified in relative fluorescence units for proteins involved in the mechanistic target of rapamycin signaling pathway. Through completion of study, 16 weeks
Secondary Change in protein expression of catabolic signaling proteins Western blotting will be performed and quantified in relative fluorescence units for proteins involved in the catabolic signaling pathways (e.g. ubiquitin-proteasome system, calpain system, autophagy). Through completion of study, 16 weeks
Secondary Change in activity of catabolic systems Activity assays will be performed and quantified in relative fluorescence units normalized to muscle soluble protein abundance in order to quantify the activity of the calpain system and the 20S proteasome core. Through completion of study, 16 weeks
Secondary Gene expression at the mRNA level of atrophy-associated genes (atrogenes) Real time quantitative polymerase chain reactions (qPCR) will be used to quantify the expression of select genes associated with atrophy. These data will be reported as fold-change from baseline and will be normalized to one or more housekeeping genes whose value does not change throughout the duration of the study. Through completion of study, 16 weeks
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