HealthyNCT02179307
Individual Response to Different Volumes of Resistance Training
A study testing 12-week progressive strength training protocol in people with Healthy, run by Inland Norway University of Applied Sciences at 1 site in Norway.
Trial summary
The literature is not clear as to which training volume to employ during initial phases of resistance training programs to ensure optimal muscular adaptations. The purpose of this study is therefore to compare effects of strength training with low versus moderate volume on muscular function and hypertrophy in… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 12-week progressive strength training protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Apr 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Non-smoking
- Able to tolerate resistance exercise training
Who cannot join
- Presence or history of cardiovascular, metabolic, endocrine or neuromuscular disease
- Diagnosed mental health disorder
- Intolerance to local anesthetic
- No experience with exercise training
- Performing regular resistance training (more than 1 session per week during last 12 months)
- Impaired strength/ neuromuscular function due to previous injury
- Recurrent pain in lower back, knee or shoulders
- Taking prescribed medication that may affect outcome of training intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Intra-individual Variation in Adaptability to Resistance Training of Different Volumes
The literature is not clear as to which training volume to employ during initial phases of resistance training programs to ensure optimal muscular adaptations. The purpose of this study is therefore to compare effects of strength training with low versus moderate volume on muscular function and hypertrophy in previously untrained, healthy individuals. Furthermore, the investigators will relate individual variation in responses to proxy markers of individual training state, such as baseline muscular function and muscle fiber type.
The study will include 25 women and 25 men and will consist of a 12-week resistance training protocol. Each study participant will act as their own control, performing both the low- (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or non-dominant leg, in a stratified and randomized fashion.
Read more
Primary outcome measures are thigh muscle cross section area and unilateral knee extension strength. Additionally, muscle fiber type composition will be evaluated as well as additional parameters of muscular function.
The primary hypothesis is that low-volume protocols will be beneficial for individuals with glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more aerobic phenotypes.
- Conditions
- Healthy
- Being tested
- 12-week progressive strength training protocol
- Keywords
- muscle hypertrophy, strength, resistance training, exercise, physical fitness, health, physical conditioning
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week progressive strength training protocolBehavioural
Every study participant will complete 12 weeks of progressive strength training with one leg performing 1-set per exercise per session and the contralateral leg performing 3-sets per exercise per session. Allocation of dominant/non-dominant leg to either 1- or 3-set protocol will be done in a stratified, randomized fashion (stratified with regard to sex and baseline strength).
| Study group | Role | What they receive |
|---|---|---|
| Arm label 1-Set, 3-Set | Experimental | 12-week progressive strength training protocol of different volumes Receives: Behavioral: 12-week progressive strength training protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh muscle cross-sectional area
Changes in muscle cross sectional area of each thigh from baseline to post intervention, assessed by MRI.
Measured: Week 0 (baseline) and 12 (post training intervention)
Unilateral knee-extension isometric strength
Time course changes in maximum knee extensor, isometric strength evaluated at 120° knee angle (180° fully extended).
Measured: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
Secondary outcomes (6)
Muscle strength
Time course changes in maximum isoinertial strength defined by one-repetition maximum in leg press, knee extension, knee flexion, and bench press.
Measured: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
Knee extensors and flexors force-velocity relationship
Time course changes in torque measured during maximal voluntary isokinetic contraction at 60°, 120° and 240° ∙ sec-1.
Measured: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
Blood hormonal profiles
Resting (week 0, 2 and 12) and acutely exercise-induced (week 2) hormonal profiles (testosterone, insulin-like growth factor 1, growth hormone and cortisol) determined in serum from venous blood samples.
Measured: Week 0 (baseline), 2 and 12 (post training intervention)
Muscle fiber cross-sectional area
Changes in muscle fiber cross-sectional area assessed by immunohistochemistry from muscle biopsy. Determined from muscle biopsy samples (Vastus lateralis).
Measured: Week 0 (baseline), 2 and 12 (post training intervention)
Protein expression
Changes in relative abundance of contractile protein isoforms (myosin heavy chain). Modification of proteins related to muscle hypertrophy in relation to an acute exercise session (assessed during week 2 of the intervention). Determined from muscle biopsy samples (Vastus lateralis).
Measured: Week 0 (baseline), 2 and 12 (post training intervention)
Gene expression
Changes in gene expression related to skeletal muscle hypertrophy and structural phenotype measured in steady state conditions (biopsy sampled in resting conditions, week 0, 2 and 12) and in relation to acute exercise (biopsy sampled 1-h after strength exercise, week 2). Determined from muscle biopsy samples (Vastus lateralis).
Measured: Week 0 (baseline), 2 and 12 (post training intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Revmatismesykehuset AS
- Responsible party
- Sponsor
- Investigators
- Stian Ellefsen, PhD, Principal investigator, Inland Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179307
- Sponsor's protocol ID
- Trainsome 2014#002
- Status last verified
- Nov 2015
- First submitted
- 27 Jun 2014
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Intra-individual Variation in Adaptability to Resistance Training of Different Volumes
- ClinicalTrials.gov ID
- NCT02179307
- Acronym / sponsor ID
- Trainsome 2014#002
- Conditions
- Healthy
- Keywords
- muscle hypertrophy, strength, resistance training, exercise, physical fitness, health, physical conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Revmatismesykehuset AS
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Jul 2014 (estimated)
- 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 literature is not clear as to which training volume to employ during initial phases of resistance training programs to ensure optimal muscular adaptations. The purpose of this study is therefore to compare effects of strength training with low versus moderate volume on muscular function and hypertrophy in previously untrained, healthy individuals. Furthermore, the investigators will relate individual variation in responses to proxy markers of individual training state, such as baseline muscular function and muscle fiber type.
The study will include 25 women and 25 men and will consist of a 12-week resistance training protocol. Each study participant will act as their own control, performing both the low- (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or non-dominant leg, in a stratified and randomized fashion.
Primary outcome measures are thigh muscle cross section area and unilateral knee extension strength. Additionally, muscle fiber type composition will be evaluated as well as additional parameters of muscular function.
The primary hypothesis is that low-volume protocols will be beneficial for individuals with glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more aerobic phenotypes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm label 1-Set, 3-Set | Experimental | Behavioral: 12-week progressive strength training protocol12-week progressive strength training protocol of different volumes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Non-smoking
- Able to tolerate resistance exercise training
Key exclusion criteria (8 listed)
- Presence or history of cardiovascular, metabolic, endocrine or neuromuscular disease
- Diagnosed mental health disorder
- Intolerance to local anesthetic
- No experience with exercise training
- Performing regular resistance training (more than 1 session per week during last 12 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 |
|---|---|---|
| 12-week progressive strength training protocolEvery study participant will complete 12 weeks of progressive strength training with one leg performing 1-set per exercise per session and the contralateral leg performing 3-sets per exercise per session. Allocation of dominant/non-dominant leg to either 1- or 3-set protocol will be done in a stratified, randomized fashion (stratified with regard to sex and baseline strength). | Behavioural | Arm label 1-Set, 3-Set |
Primary outcome
Thigh muscle cross-sectional area
Time frame: Week 0 (baseline) and 12 (post training intervention)
Changes in muscle cross sectional area of each thigh from baseline to post intervention, assessed by MRI.
Unilateral knee-extension isometric strength
Time frame: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
Time course changes in maximum knee extensor, isometric strength evaluated at 120° knee angle (180° fully extended).
6 secondary outcomes
Muscle strength
Time frame: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
Knee extensors and flexors force-velocity relationship
Time frame: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
Blood hormonal profiles
Time frame: Week 0 (baseline), 2 and 12 (post training intervention)
Muscle fiber cross-sectional area
Time frame: Week 0 (baseline), 2 and 12 (post training intervention)
Protein expression
Time frame: Week 0 (baseline), 2 and 12 (post training intervention)
Gene expression
Time frame: Week 0 (baseline), 2 and 12 (post training intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
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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.
Stian Ellefsen, PhD principal investigator
Inland Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week progressive strength training protocol in people with Healthy, run by Inland Norway University of Applied Sciences at 1 site in Norway.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh muscle cross-sectional area (time frame: Week 0 (baseline) and 12 (post training intervention)). The study lists 2 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 6 Nov 2015.