HealthyNCT03795025
ContraTRAIN - a Validation Study of Contralateral Training Protocols
A study testing Strength training 3x10RM + no training, Strength training 6x10RM + no training and 3x10RM + 6x10RM in people with Healthy, run by Inland Norway University of Applied Sciences at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Strength training 3x10RM + no training, Strength training 6x10RM + no training and 3x10RM + 6x10RM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- 8 Jan 2019to 12 Mar 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Strength training 3x10RM + no training, Strength training 6x10RM + no training, 3x10RM + 6x10RM
- Keywords
- Contralateral, Strength training, Muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training 3x10RM + no trainingOther
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.
Strength training 6x10RM + no trainingOther
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.
3x10RM + 6x10RMOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 3x10RM + no training | Experimental | Not described Receives: Other: Strength training 3x10RM + no training |
| 6x10RM + no training | Experimental | Not described Receives: Other: Strength training 6x10RM + no training |
| 3x10RM + 6x10RM | Experimental | Not described Receives: Other: 3x10RM + 6x10RM |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fiber area
Muscle cell cross-sectional area measured in biopsies from m. vastus lateralis using immunohistochemistry
Measured: Changes over the course of the intervention (0-10 weeks)
Secondary outcomes (15)
Body mass composition
Body mass composition measured using Dual-energy X-ray absorptiometry (DXA)
Measured: Changes over the course of the intervention (0-10 weeks)
Rate of muscle protein synthesis (%/day)
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.
Measured: Mesured over 3 days in week 7 of the study
M. vastus lateralis thickness
- vastus lateralis thickness mesured by ultrasound
Measured: Changes over the course of the intervention (0-10 weeks)
Unilateral leg press strength (1RM test)
The ability of muscles of the lower body to exert maximal force during dynamic movements in a leg press
Measured: Changes over the course of the intervention (0-10 weeks)
Unilateral knee extension strength (1RM test)
The ability of muscles of the lower body to exert maximal force during dynamic movements in a knee extension
Measured: Changes over the course of the intervention (0-10 weeks)
Barbell bench press muscle strength (1RM test)
The ability of muscles of the upper body to exert maximal force during dynamic movements in a bench press
Measured: Changes over the course of the intervention (0-10 weeks)
Lying rowing muscle strength (1RM test)
The ability of muscles of the upper body to exert maximal force during dynamic movements in a lying row exercise
Measured: Changes over the course of the intervention (0-10 weeks)
Unilateral lower body isokinetic muscle strength at 60 and 240 deg per second in a mechanical dynamometer (Humac NORM)
The ability of muscles of the lower body to exert maximal force during isokinetic movements
Measured: Changes over the course of the intervention (0-10 weeks)
Unilateral lower body isometric muscle strength in a mechanical dynamometer (Humac NORM)
The ability of muscles of the lower body to exert maximal force during isometric contractions
Measured: Changes over the course of the intervention (0-10 weeks)
One-legged cycling
Performance indicies measured during an incremental one-legged cycling test
Measured: Changes over the course of the intervention (0-10 weeks)
Muscle phenotype
Muscle fiber type composition measured in biopsies from m. vastus lateralis using immunohistochemistry
Measured: Changes over the course of the intervention (0-10 weeks)
Muscle cell biological traits
Muscle cell biological traits, including numbers of myonuclei, satelitte cells and capillaries, measured in biopsies from m. vastus lateralis using immunohistochemistry
Measured: Changes over the course of the intervention (0-10 weeks)
Gene expression in skeletal muscle
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
Measured: Changes over the course of the intervention (0-10 weeks)
Protein abundances in skeletal muscle measured by western blot
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
Measured: Changes over the course of the intervention (0-10 weeks)
Hormones in blood
Levels of hormones in blood
Measured: Changes over the course of the intervention (0-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start8 Jan 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795025
- Sponsor's protocol ID
- Trainome 2019#014
- Status last verified
- May 2020
- First submitted
- 21 Dec 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ContraTRAIN - a Validation Study of Contralateral Training Protocols
- ClinicalTrials.gov ID
- NCT03795025
- Acronym / sponsor ID
- Trainome 2019#014
- Conditions
- Healthy
- Keywords
- Contralateral, Strength training, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 7 Jan 2019 (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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3x10RM + no training | Experimental | Other: Strength training 3x10RM + no training |
| 6x10RM + no training | Experimental | Other: Strength training 6x10RM + no training |
| 3x10RM + 6x10RM | Experimental | Other: 3x10RM + 6x10RM |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Strength training 3x10RM + no trainingProgressive 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. | Other | 3x10RM + no training |
| Strength training 6x10RM + no trainingProgressive 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. | Other | 6x10RM + no training |
| 3x10RM + 6x10RMProgressive 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. | Other | 3x10RM + 6x10RM |
Primary outcome
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
15 secondary outcomes
Body mass composition
Time frame: Changes over the course of the intervention (0-10 weeks)
Rate of muscle protein synthesis (%/day)
Time frame: Mesured over 3 days in week 7 of the study
M. vastus lateralis thickness
Time frame: Changes over the course of the intervention (0-10 weeks)
Unilateral leg press strength (1RM test)
Time frame: Changes over the course of the intervention (0-10 weeks)
Unilateral knee extension strength (1RM test)
Time frame: Changes over the course of the intervention (0-10 weeks)
Barbell bench press muscle strength (1RM test)
Time frame: Changes over the course of the intervention (0-10 weeks)
Lying rowing muscle strength (1RM test)
Time frame: Changes over the course of the intervention (0-10 weeks)
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)
Unilateral lower body isometric muscle strength in a mechanical dynamometer (Humac NORM)
Time frame: Changes over the course of the intervention (0-10 weeks)
One-legged cycling
Time frame: Changes over the course of the intervention (0-10 weeks)
Muscle phenotype
Time frame: Changes over the course of the intervention (0-10 weeks)
Muscle cell biological traits
Time frame: Changes over the course of the intervention (0-10 weeks)
Gene expression in skeletal muscle
Time frame: Changes over the course of the intervention (0-10 weeks)
Protein abundances in skeletal muscle measured by western blot
Time frame: Changes over the course of the intervention (0-10 weeks)
Hormones in blood
Time frame: Changes over the course of the intervention (0-10 weeks)
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 19 May 2020.
- Individual participant dataSharing planned: Yes. 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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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training 3x10RM + no training, Strength training 6x10RM + no training and 3x10RM + 6x10RM 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 1 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: finished, as of the sponsor's last update on 19 May 2020. 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?
Muscle fiber area (time frame: Changes over the course of the intervention (0-10 weeks)). 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 19 May 2020.