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Individual Response to Different Volumes of Resistance Training

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ClinicalTrials.gov Identifier: NCT02179307
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : November 6, 2015
Sponsor:
Collaborators:
Sykehuset Innlandet HF
Revmatismesykehuset AS
Information provided by (Responsible Party):
Inland Norway University of Applied Sciences

Tracking Information
First Submitted Date  ICMJE June 27, 2014
First Posted Date  ICMJE July 1, 2014
Last Update Posted Date November 6, 2015
Study Start Date  ICMJE August 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02179307 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
  • Muscle strength [ Time Frame: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention) ]
    Time course changes in maximum isoinertial strength defined by one-repetition maximum in leg press, knee extension, knee flexion, and bench press.
  • Knee extensors and flexors force-velocity relationship [ Time Frame: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention) ]
    Time course changes in torque measured during maximal voluntary isokinetic contraction at 60°, 120° and 240° ∙ sec-1.
  • Blood hormonal profiles [ Time Frame: Week 0 (baseline), 2 and 12 (post training intervention) ]
    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.
  • Muscle fiber cross-sectional area [ Time Frame: Week 0 (baseline), 2 and 12 (post training intervention) ]
    Changes in muscle fiber cross-sectional area assessed by immunohistochemistry from muscle biopsy. Determined from muscle biopsy samples (Vastus lateralis).
  • Protein expression [ Time Frame: Week 0 (baseline), 2 and 12 (post training intervention) ]
    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).
  • Gene expression [ Time Frame: Week 0 (baseline), 2 and 12 (post training intervention) ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
  • Muscle strength [ Time Frame: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention) ]
    Time course changes in maximum isoinertial strength defined by one-repetition maximum in knee extension, knee flexion, shoulder press, latissimus pull-down and bench press.
  • Knee extensors and flexors force-velocity relationship [ Time Frame: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention) ]
    Time course changes in torque measured during maximal voluntary isokinetic contraction at 60°, 120° and 240° ∙ sec-1.
  • Blood hormonal profiles [ Time Frame: Week 0 (baseline), 2 and 12 (post training intervention) ]
    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.
  • Muscle fiber cross-sectional area [ Time Frame: Week 0 (baseline), 2 and 12 (post training intervention) ]
    Changes in muscle fiber cross-sectional area assessed by immunohistochemistry from muscle biopsy. Determined from muscle biopsy samples (Vastus lateralis).
  • Protein expression [ Time Frame: Week 0 (baseline), 2 and 12 (post training intervention) ]
    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).
  • Gene expression [ Time Frame: Week 0 (baseline), 2 and 12 (post training intervention) ]
    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).
Current Other Pre-specified Outcome Measures
 (submitted: June 30, 2014)
  • Body composition changes [ Time Frame: Week 0 (baseline) and 12 (post training intervention) ]
    Changes in body compositions (lean mass and fat mass) from prior intervention to after intervention assessed by dual x-ray absorptiometry scan.
  • Habitual physical activity [ Time Frame: Week 0 ]
    Self-reported prior habitual physical activity assessed by questionnaire and interview before training intervention
  • Daily nutrient intake [ Time Frame: Week 6 ]
    Daily nutrient intake assessed by a 4-day food intake registration.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Individual Response to Different Volumes of Resistance Training
Official Title  ICMJE Determinants of Intra-individual Variation in Adaptability to Resistance Training of Different Volumes
Brief 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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Behavioral: 12-week progressive strength training protocol
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 Arms  ICMJE Experimental: Arm label 1-Set, 3-Set
12-week progressive strength training protocol of different volumes
Intervention: Behavioral: 12-week progressive strength training protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2015)
42
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2014)
50
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy
  • Non-smoking
  • Able to tolerate resistance exercise training

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02179307
Other Study ID Numbers  ICMJE Trainsome 2014#002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Inland Norway University of Applied Sciences
Study Sponsor  ICMJE Inland Norway University of Applied Sciences
Collaborators  ICMJE
  • Sykehuset Innlandet HF
  • Revmatismesykehuset AS
Investigators  ICMJE
Principal Investigator: Stian Ellefsen, PhD Inland Norway University of Applied Sciences
PRS Account Inland Norway University of Applied Sciences
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP