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ContraTRAIN - a Validation Study of Contralateral Training Protocols

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ClinicalTrials.gov Identifier: NCT03795025
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
University of Birmingham
Information provided by (Responsible Party):
Inland Norway University of Applied Sciences

Brief Summary:
This study aims to validate the use of contralateral designs in studies of effects of resistance exercise. It will recruit healthy young (18-35 years) individuals, which will be allocated to 4 experimental groups. In two of the experimental groups, 3x10 or 6x10 repetitions of heavy resistance exercise on one leg will be combined with no training of the other leg for 7 weeks. In the third group, 3x10 repetitions of heavy resistance exercise on one leg will be combined with 6x10 repetitions of heavy resistance exercise on the other leg for 7 weeks. In the fourth group, which serves as a control group, a period of no training (similar in length to the training period of groups 1-3; 7 weeks), before both legs will train 3x10 repetitions of heavy resistance exercise in an unilateral manner.

Condition or disease Intervention/treatment Phase
Healthy Other: Strength training 3x10RM + no training Other: Strength training 6x10RM + no training Other: 3x10RM + 6x10RM Not Applicable

Detailed Description:

Our understanding of how exercise affects muscular adaptations at the cellular and molecular level comes from the use of skeletal muscle biopsies. Such studies are met by several challenges, including its invasive nature, costs of muscle analyses, large inter-participant variability in response to exercise and a limited number of subjects (related to ethical concerns regarding exposing participants to biopsies). Consequently, studies often include small sample sizes, resulting in low statistical power. This poses a great challenge to the field of exercise physiology. While increasing sample size may not always be feasible, employing alternative designs may offer a way to increase the statistical power. An example of such a design is the so-called cross-over design, wherein participants serve as their own control thereby reducing the inter-participant variation. An interesting variant of the cross-over design is the unilateral or contralateral exercise model. In such designs, each of the participant's limbs (e.g. legs) are randomly allocated to perform different types of training/treatments in close temporal proximity. This design obliterates the need for a wash-out period and removes the potential effects of confounding factors such as diet, activity and sleep decreases. Thus, resources, time spent and variability can be reduced. However, validation of such studies is lacking.

In an effort to validate a contralateral training design, the investigators will recruit young (18-35 years) healthy individuals to 4 groups performing unilateral progressive strength training; (1) one leg with no training and one leg with 3x10 maximal repetitions, (2) one leg with no training and one leg with 6x10 maximal repetitions, (3) one leg with 3x10 maximal repetitions and one leg with 6x10 maximal repetitions and (4) a control group with an initial period of no training (similar in length to the training period of groups 1-3) followed by a period of 3x10 maximal repetitions on each leg. Leg training will consist of one-legged leg press and one-legged knee extensions. All groups, except the control group (during the no-training control period), will train the upper body by 3x10 maximal repetitions in bench press and lying rowing. Prior to the 7 week training intervention, all four groups will go through a 3-week period of familiarization to training and repeated testing (4 test time points for performance measures).

This design allows us to investigate the benefits of a contralateral design compared to the more common two-group design, the intra-individual variation vs the inter-individual variation, the potential contralateral effect of training one leg on the physiology and functional abilities of the non-trained leg, and whether or not these perspective are affected by training volume. We will also investigate whether participant classification into low or high responders is universal across several measures of muscle mass and strength, and between different training volumes. Further, by measuring several hypertrophy-related outcomes (e.g. changes in ribosome volume, activation of satellite cells and transcriptional changes), the investigators will extend previous findings regarding the effects of training volume on these variables and their ability to predict training outcomes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: ContraTRAIN - a Validation Study of Contralateral Training Protocols
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: 3x10RM + no training Other: Strength training 3x10RM + no training
Progressive unilateral strength training 3 times per week for 3 + 7 weeks. One leg exercises with 3 sets of 10 maximal repetitions, the other leg does not exercise.

Experimental: 6x10RM + no training Other: Strength training 6x10RM + no training
Progressive unilateral strength training 3 times per week for 3 + 7 weeks. One leg exercises with 6 sets of 10 maximal repetitions, the other leg does not exercise.

Experimental: 3x10RM + 6x10RM Other: 3x10RM + 6x10RM
Progressive unilateral strength training 3 times per week for 3 + 7 weeks. One leg exercises with 3 sets of 10 maximal repetitions, the other leg exercises with 6 sets of 10 maximal repetitions.

No Intervention: Control
This arm includes 3 weeks of testing and 7 weeks of no intervention and post tests, followed by 7 weeks of progressive unilateral strength training 3 times per week for 7 weeks. Both legs exercises individually with 3 sets of 10 maximal repetitions.



Primary Outcome Measures :
  1. Muscle fiber area [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    Muscle cell cross-sectional area measured in biopsies from m. vastus lateralis using immunohistochemistry


Secondary Outcome Measures :
  1. Body mass composition [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    Body mass composition measured using Dual-energy X-ray absorptiometry (DXA)

  2. Rate of muscle protein synthesis (%/day) [ Time Frame: Mesured over 3 days in week 7 of the study ]
    By ingesting deuterium we will label alanine to measure the rate of its incorporation into muscle proteins. This is done by collection of blood before, during and after, and a biopsy 3 days after deuterium ingestion to be analyzed with chromatography and mass spectrometry. Results will be reported as a rate of synthesis in %/day.

  3. M. vastus lateralis thickness [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    M. vastus lateralis thickness mesured by ultrasound

  4. Unilateral leg press strength (1RM test) [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    The ability of muscles of the lower body to exert maximal force during dynamic movements in a leg press

  5. Unilateral knee extension strength (1RM test) [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    The ability of muscles of the lower body to exert maximal force during dynamic movements in a knee extension

  6. Barbell bench press muscle strength (1RM test) [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    The ability of muscles of the upper body to exert maximal force during dynamic movements in a bench press

  7. Lying rowing muscle strength (1RM test) [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    The ability of muscles of the upper body to exert maximal force during dynamic movements in a lying row exercise

  8. Unilateral lower body isokinetic muscle strength at 60 and 240 deg per second in a mechanical dynamometer (Humac NORM) [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    The ability of muscles of the lower body to exert maximal force during isokinetic movements

  9. Unilateral lower body isometric muscle strength in a mechanical dynamometer (Humac NORM) [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    The ability of muscles of the lower body to exert maximal force during isometric contractions

  10. One-legged cycling [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    Performance indicies measured during an incremental one-legged cycling test

  11. Muscle phenotype [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    Muscle fiber type composition measured in biopsies from m. vastus lateralis using immunohistochemistry

  12. Muscle cell biological traits [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    Muscle cell biological traits, including numbers of myonuclei, satelitte cells and capillaries, measured in biopsies from m. vastus lateralis using immunohistochemistry

  13. Gene expression in skeletal muscle [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    RNA (e.g. messenger RNA, ribosomal RNA, microRNA, long non-coding RNA) abundances in m. vastus lateralis, measured both as single genes and at the level of the transcriptome

  14. Protein abundances in skeletal muscle measured by western blot [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    Levels of proteins and their modification status (e.g. phosphorylation) in m. vastus lateralis, measured at the level of single proteins and at the level of the proteome

  15. Hormones in blood [ Time Frame: Changes over the course of the intervention (0-10 weeks) ]
    Levels of hormones in blood



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Smoking
  • Strength training more than 2 times per months for the last 6 months
  • Endurance training more than 3 hours per week
  • Adverse reactions to lidocaine
  • Consumption of supplements or medication affecting muscular adaptations to strength training

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795025


Contacts
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Contact: Håvard Hamarsland, PhD 93445916 ext +47 havard.hamarsland@inn.no
Contact: Stian Ellefsen, PhD 97666521 ext +47 Stian.Ellefsen@hil.no

Locations
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Norway
Inland Norway University of Applied Sciences Recruiting
Lillehammer, Norway
Contact: Stian Ellefsen, PhD       stian.ellefsen@hil.no   
Sponsors and Collaborators
Inland Norway University of Applied Sciences
University of Birmingham

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Responsible Party: Inland Norway University of Applied Sciences
ClinicalTrials.gov Identifier: NCT03795025     History of Changes
Other Study ID Numbers: Trainome 2019#014
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available to the academic community through the general biobank "The Trainsome - effects of exercise and environment on human cells" (REK-2013/2045, Regional Comitees for Medical and Health Research Ethics South East). Data will be available on request and will be restricted to scientists and/or projects with a sound scientific purpose and rationale.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inland Norway University of Applied Sciences:
Contralateral
Strength training
Muscle