Atrophy, DisuseNCT05760066
Effects of Resistance Training Preconditioning on Skeletal Muscle Recovery From a Period of Disuse in Young Adults
A study testing Resistance Training Preconditioning in people with Atrophy, Disuse and Atrophy, Muscular, run by Auburn University.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophy, Disuse, Atrophy, Muscular
- What is being tested?
- Resistance Training Preconditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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
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.
- Conditions
- Atrophy, Disuse, Atrophy, Muscular
- Being tested
- Resistance Training Preconditioning, Control
- Medical subject headings
- Muscular Disorders, Atrophic, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training PreconditioningOther
Resistance training prior to disuse-induced atrophy followed by another period of resistance training
ControlOther
Activities of daily living prior to disuse-induced atrophy followed by a period of resistance training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Through completion of study, 16 weeks
Change in quadriceps strength via isokinetic dynamometry
Strength of the quadriceps will be assessed via isokinetic dynamometry
Measured: Through completion of study, 16 weeks
Secondary outcomes (4)
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.
Measured: Through completion of study, 16 weeks
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).
Measured: Through completion of study, 16 weeks
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.
Measured: Through completion of study, 16 weeks
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.
Measured: Through completion of study, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy, DisuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Roberts, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760066
- Sponsor's protocol ID
- MDR0823
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training Preconditioning on Skeletal Muscle Recovery From a Period of Disuse in Young Adults
- ClinicalTrials.gov ID
- NCT05760066
- Acronym / sponsor ID
- MDR0823
- Conditions
- Atrophy, Disuse, Atrophy, Muscular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Preconditioning (PRECON) | Experimental | Other: Resistance Training PreconditioningThis 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 |
| Control (CTL) | Active comparator | Other: ControlThis 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Training PreconditioningResistance training prior to disuse-induced atrophy followed by another period of resistance training | Other | Resistance Training Preconditioning (PRECON) |
| ControlActivities of daily living prior to disuse-induced atrophy followed by a period of resistance training | Other | Control (CTL) |
Primary outcome
Change in vastus lateralis fiber cross-sectional area
Time frame: Through completion of study, 16 weeks
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
Change in quadriceps strength via 3 repetition maximum testing
Time frame: Through completion of study, 16 weeks
Strength of the quadriceps will be assessed via 3-repetition maximum testing of select exercises (leg press, leg extension, hex-bar deadlift)
Change in quadriceps strength via isokinetic dynamometry
Time frame: Through completion of study, 16 weeks
Strength of the quadriceps will be assessed via isokinetic dynamometry
4 secondary outcomes
Change in protein expression of anabolic signaling proteins
Time frame: Through completion of study, 16 weeks
Change in protein expression of catabolic signaling proteins
Time frame: Through completion of study, 16 weeks
Change in activity of catabolic systems
Time frame: Through completion of study, 16 weeks
Gene expression at the mRNA level of atrophy-associated genes (atrogenes)
Time frame: Through completion of study, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training Preconditioning in people with Atrophy, Disuse and Atrophy, Muscular, run by Auburn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael D Roberts, PhD (334-844-1925, mdr0024@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vastus lateralis fiber cross-sectional area (time frame: Through completion of study, 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.