Muscle HypertrophyNCT03993483
Upper Versus Lower Limb Responses to Higher Versus Lower Load Resistance Training in Young Men
A study testing Unilateral resistance exercise in people with Muscle Hypertrophy and Muscle Strength, run by McMaster University at 1 site in Canada.
Trial summary
Recent research suggests that performing resistance exercise training with relatively light loads is equally as effective at increasing muscle mass and muscle strength as performing resistance exercise training with relatively heavy loads. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Hypertrophy, Muscle Strength
- What is being tested?
- Unilateral resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 5 Oct 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18-30 years (inclusive)
- Be able to maintain a habitual diet and perform resistance exercise three times per week throughout the trial
- Be in general good health (assessed by Get Active Questionnaire)
- Understand the study procedures and sign this form providing informed consent to participate in the study.
Who cannot join
- Use of tobacco or related products
- A history of neuromuscular problems or muscle and/or bone wasting diseases
- Any acute or chronic illness; cardiac, pulmonary, liver, or kidney abnormalities; insulin- or non-insulin-dependent diabetes or other metabolic disorders (all ascertained through medical questionnaires)
- Use of medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatory drugs (prescription use or daily use of over the counter medication), or prescription strength acne medications)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: Variability in Resistance Training-induced Hypertrophy and Strength Are Independent of Load and Limb Location in Healthy Young Men
Recent research suggests that performing resistance exercise training with relatively light loads is equally as effective at increasing muscle mass and muscle strength as performing resistance exercise training with relatively heavy loads. Whether or not performing resistance exercise with relatively heavy loads or light loads is equally as effective between the upper- and lower-body within the same individual has never been investigated. Given the substantial individual variance in resistance exercise training-induced changes in muscle mass and strength, this study is designed to quantify the relative influence that extrinsic training variables (e.g., load), as opposed to intrinsic muscle-based predisposition, has on resistance training-induced changes in muscle mass and muscle strength.
Read the detailed description
Each participant will come to the Exercise Metabolism Research Laboratory gym three times per week for 10 weeks to perform lower- and upper-body resistance exercise training with both relatively heavy- (~80% one repetition maximum [1RM]) and light- (~40 %1RM) loads. One arm and one leg will be randomized to lift with relatively heavy loads such that the other arm and leg will be randomized to lift with relatively light loads. Each workout will be supervised by a study investigator.
The time commitment of this study is 12 weeks (including pre- and post-study testing). Each workout to take 30 minutes and, with testing days included, the investigators foresee a total time commitment of 41 hours, or just under three and half hours per week.
The pre- and post-study measurements include muscle biopsies, dual x-ray absorptiometry scans, ultrasonography scans, 1RM assessment, and maximum voluntary contraction assessment. The muscle biopsies will be taken from each of the participant's vastus lateralis to assess muscle fibre cross sectional area in both legs during the beginning (four biopsies) and end (four biopsies) of the intervention. The dual x-ray absorptiometry scans are used to assess body composition and will be done pre- and post-intervention. The ultrasonography scans will be used to assess biceps brachii and vastus laterals thickness and cross sectional area. The ultrasound scans will be assessed during the beginning (four scans) and end (four scans) of the intervention. The 1RM assessment will include 1RM testing on a knee extension machine and biceps curl machine and will be done at the beginning and end of the intervention. The maximum voluntary contraction assessment will be performed on a System 3 Biodex Dynamometer (Shirley, NY, USA), which is an immovable machine that the participants contract against to measure their peak force. The maximum voluntary contractions will be recorded three times: twice at the beginning of the intervention and once at the end of the intervention.
- Conditions
- Muscle Hypertrophy, Muscle Strength
- Being tested
- Unilateral resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral resistance exerciseBehavioural
The participants performed three sets of their unilateral resistance exercise (biceps curls and knee extensions) three times per week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Higher Load | Experimental | One arm and one leg were randomized (based on limb dominance) to perform unilateral biceps curls (arm) and knee extensions (leg) with relatively higher loads (80 % of their one-repetition maximum). Receives: Behavioral: Unilateral resistance exercise |
| Lower Load | Experimental | The other arm and leg were randomized (based on limb dominance) to perform unilateral biceps curls (arm) and knee extensions (leg) with relatively higher loads (80 % of their one-repetition maximum). Receives: Behavioral: Unilateral resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat-free mass
Measured by dual x-ray absorptiometry pre- and post-training
Measured: up to 12 weeks
Change in vastus lateralis thickness
Measured by ultrasonography pre- and post-training
Measured: up to 12 weeks
Change in vastus lateralis cross sectional area
Measured by ultrasonography pre- and post-training
Measured: up to 12 weeks
Change in biceps brachii thickness
Measured by ultrasonography pre- and post-training
Measured: up to 12 weeks
Change in biceps brachii cross sectional area
Measured by ultrasonography pre- and post-training
Measured: up to 12 weeks
Change in muscle fibre cross sectional area
Measured by muscle biopsies from the vastus lateralis pre- and post-training
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Jun 2018
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle HypertrophyStudies 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
- Model description
- One arm and one leg of each participant were randomized to lift with heavier loads while the other arm and leg of each participant were randomized to lift with lighter loads for 10 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993483
- Sponsor's protocol ID
- HIREB 4774
- Status last verified
- Jun 2019
- First submitted
- 17 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability in Resistance Training-induced Hypertrophy and Strength Are Independent of Load and Limb Location in Healthy Young Men
- ClinicalTrials.gov ID
- NCT03993483
- Acronym / sponsor ID
- HIREB 4774
- Conditions
- Muscle Hypertrophy, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 20 Jun 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.
Recent research suggests that performing resistance exercise training with relatively light loads is equally as effective at increasing muscle mass and muscle strength as performing resistance exercise training with relatively heavy loads. Whether or not performing resistance exercise with relatively heavy loads or light loads is equally as effective between the upper- and lower-body within the same individual has never been investigated. Given the substantial individual variance in resistance exercise training-induced changes in muscle mass and strength, this study is designed to quantify the relative influence that extrinsic training variables (e.g., load), as opposed to intrinsic muscle-based predisposition, has on resistance training-induced changes in muscle mass and muscle strength.
Detailed description
Each participant will come to the Exercise Metabolism Research Laboratory gym three times per week for 10 weeks to perform lower- and upper-body resistance exercise training with both relatively heavy- (~80% one repetition maximum [1RM]) and light- (~40 %1RM) loads. One arm and one leg will be randomized to lift with relatively heavy loads such that the other arm and leg will be randomized to lift with relatively light loads. Each workout will be supervised by a study investigator.
The time commitment of this study is 12 weeks (including pre- and post-study testing). Each workout to take 30 minutes and, with testing days included, the investigators foresee a total time commitment of 41 hours, or just under three and half hours per week.
The pre- and post-study measurements include muscle biopsies, dual x-ray absorptiometry scans, ultrasonography scans, 1RM assessment, and maximum voluntary contraction assessment. The muscle biopsies will be taken from each of the participant's vastus lateralis to assess muscle fibre cross sectional area in both legs during the beginning (four biopsies) and end (four biopsies) of the intervention. The dual x-ray absorptiometry scans are used to assess body composition and will be done pre- and post-intervention. The ultrasonography scans will be used to assess biceps brachii and vastus laterals thickness and cross sectional area. The ultrasound scans will be assessed during the beginning (four scans) and end (four scans) of the intervention. The 1RM assessment will include 1RM testing on a knee extension machine and biceps curl machine and will be done at the beginning and end of the intervention. The maximum voluntary contraction assessment will be performed on a System 3 Biodex Dynamometer (Shirley, NY, USA), which is an immovable machine that the participants contract against to measure their peak force. The maximum voluntary contractions will be recorded three times: twice at the beginning of the intervention and once at the end of the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One arm and one leg of each participant were randomized to lift with heavier loads while the other arm and leg of each participant were randomized to lift with lighter loads for 10 weeks.
| Arm | Type | Receives |
|---|---|---|
| Higher Load | Experimental | Behavioral: Unilateral resistance exerciseOne arm and one leg were randomized (based on limb dominance) to perform unilateral biceps curls (arm) and knee extensions (leg) with relatively higher loads (80 % of their one-repetition maximum). |
| Lower Load | Experimental | Behavioral: Unilateral resistance exerciseThe other arm and leg were randomized (based on limb dominance) to perform unilateral biceps curls (arm) and knee extensions (leg) with relatively higher loads (80 % of their one-repetition maximum). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between the ages of 18-30 years (inclusive)
- Be able to maintain a habitual diet and perform resistance exercise three times per week throughout the trial
- Be in general good health (assessed by Get Active Questionnaire)
- Understand the study procedures and sign this form providing informed consent to participate in the study.
Key exclusion criteria (4 listed)
- Use of tobacco or related products
- A history of neuromuscular problems or muscle and/or bone wasting diseases
- Any acute or chronic illness; cardiac, pulmonary, liver, or kidney abnormalities; insulin- or non-insulin-dependent diabetes or other metabolic disorders (all ascertained through medical questionnaires)
- Use of medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatory drugs (prescription use or daily use of over the counter medication), or prescription strength acne medications)
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 |
|---|---|---|
| Unilateral resistance exerciseThe participants performed three sets of their unilateral resistance exercise (biceps curls and knee extensions) three times per week for 10 weeks. | Behavioural | Higher Load, Lower Load |
Primary outcome
Change in fat-free mass
Time frame: up to 12 weeks
Measured by dual x-ray absorptiometry pre- and post-training
Change in vastus lateralis thickness
Time frame: up to 12 weeks
Measured by ultrasonography pre- and post-training
Change in vastus lateralis cross sectional area
Time frame: up to 12 weeks
Measured by ultrasonography pre- and post-training
Change in biceps brachii thickness
Time frame: up to 12 weeks
Measured by ultrasonography pre- and post-training
Change in biceps brachii cross sectional area
Time frame: up to 12 weeks
Measured by ultrasonography pre- and post-training
Change in muscle fibre cross sectional area
Time frame: up to 12 weeks
Measured by muscle biopsies from the vastus lateralis pre- and post-training
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 20 Jun 2019.
- Individual participant dataSharing planned: No. No individual participant data will be made available to other researchers
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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.
Stuart Phillips, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral resistance exercise in people with Muscle Hypertrophy and Muscle Strength, run by McMaster University at 1 site in Canada.
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 4 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 20 Jun 2019. 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 Canada. 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?
Change in fat-free mass (time frame: up to 12 weeks). The study lists 6 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 20 Jun 2019.