HypertrophyNCT05667233
Examining Changes in Muscle Size and Body Composition Between Two Hypertrophy Resistance Training Programs in Males
A study testing Resistance Training Program in people with Hypertrophy and Body Weight Changes, run by Dalhousie University at 1 site in Canada.
Trial summary
This study aims to investigate if a less physically and psychologically taxing approach to resistance training can generate equal or greater outcomes when compared to a more physically and psychologically taxing approach. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy, Body Weight Changes, Muscle Size
- What is being tested?
- Resistance Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2023to 3 Apr 2023
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- biological male
- age 18 years or older
- enrolled at Dalhousie university
- minimum 3-months of consistent (at least 2x/week) resistance training experience
Who cannot join
- body fat percentage 25% or greater (obese)
- use of performance enhancing drugs that aim to increase rate of muscle growth (i.e., androgenic steroids, anabolic steroids, selective androgen receptive modulators, growth hormone).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Examining Differences in Waist, Upper-arm, Mid-thigh Circumference and Body Composition When Training to Momentary Muscular Fatigue Versus Close Failure-proximity Amongst Healthy Male Biological Sex University-aged Students
This study aims to investigate if a less physically and psychologically taxing approach to resistance training can generate equal or greater outcomes when compared to a more physically and psychologically taxing approach.
Read the detailed description
Resistance training is commonly used to improve body composition, gain strength, increase muscle size (i.e., hypertrophy) and prevent muscle atrophy (i.e., muscle wasting). The most optimal mode of building muscle remains unclear, however there are many mechanisms that can be tested to yield optimal results. One variable that can be manipulated when designing a hypertrophy-focused resistance training regimen is intensity (i.e., proximity-to-failure). Proximity-to-failure is defined as the number of repetitions remaining in a set of prescribed exercises prior to reaching momentary muscular failure (MMF). MMF is when an individual cannot complete the lowering or concentric phase of a given repetition with a full range-of-motion without deviation from the prescribed form of the exercise. For all lifters, particularly amongst older populations, it can be psychologically demanding to push to MMF, and may increase the risk of delayed onset muscle soreness (DOMS) and/or injury due to technical breakdown. In contrast, there is some evidence that suggests training to a slightly less intensity (i.e., within 1-4 repetitions in reserve [RIR]) may result in comparable hypertrophic results with less of a physical and psychological demand on participants.
For these reasons, this study looks to investigate if an easier (i.e., less intense) approach to training such as training with repetitions in reserve (RIR), warrants similar or better muscle hypertrophy adaptations to MMF.
- Conditions
- Hypertrophy, Body Weight Changes, Muscle Size
- Being tested
- Resistance Training Program
- Keywords
- Exercise, Resistance Training
- Medical subject headings
- Hypertrophy, Body Weight Changes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training ProgramOther
Participants will undergo a high exertion machine-based resistance training protocol.
| Study group | Role | What they receive |
|---|---|---|
| Train to failure | Active comparator | Training regime will be highly uncomfortable since it will be both physically and psychologically challenging to push to momentary muscular fatigue (MMF; i.e., failure). Receives: Other: Resistance Training Program |
| Train to non-failure | Active comparator | Training regime will be moderately uncomfortable as participants will be training at a close proximity to failure (4-0 repetitions in reserve; i.e., non-failure). Receives: Other: Resistance Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segment girth (cm)
Upper arm (biceps) circumference, mid-thigh (quadriceps) circumference, waist (abdomen) circumference
Measured: 8-weeks
Secondary outcomes (2)
Body composition (kg)
Fat mass, Fat-free mass, Total Body Mass (fat mass + fat free mass)
Measured: 8-weeks
Body Fat Percentage
Fat Mass (kg) / Total Body mass (kg) * 100
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start6 Feb 2023
- Primary completion27 Mar 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Participants will be randomly assigned to one of two parallel groups (train to failure OR train to non-failure) and stratified according to their recent training experience (beginner \[3-9 months experience\], intermediate \[9-18 months experience\], advanced \[\>18 months experience\]).
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffery Zahavich, PhD, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667233
- Sponsor's protocol ID
- 2022-6399
- Status last verified
- Aug 2023
- First submitted
- 19 Dec 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining Differences in Waist, Upper-arm, Mid-thigh Circumference and Body Composition When Training to Momentary Muscular Fatigue Versus Close Failure-proximity Amongst Healthy Male Biological Sex University-aged Students
- ClinicalTrials.gov ID
- NCT05667233
- Acronym / sponsor ID
- 2022-6399
- Conditions
- Hypertrophy, Body Weight Changes, Muscle Size
- Keywords
- Exercise, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 28 Dec 2022 (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 investigate if a less physically and psychologically taxing approach to resistance training can generate equal or greater outcomes when compared to a more physically and psychologically taxing approach.
Detailed description
Resistance training is commonly used to improve body composition, gain strength, increase muscle size (i.e., hypertrophy) and prevent muscle atrophy (i.e., muscle wasting). The most optimal mode of building muscle remains unclear, however there are many mechanisms that can be tested to yield optimal results. One variable that can be manipulated when designing a hypertrophy-focused resistance training regimen is intensity (i.e., proximity-to-failure). Proximity-to-failure is defined as the number of repetitions remaining in a set of prescribed exercises prior to reaching momentary muscular failure (MMF). MMF is when an individual cannot complete the lowering or concentric phase of a given repetition with a full range-of-motion without deviation from the prescribed form of the exercise. For all lifters, particularly amongst older populations, it can be psychologically demanding to push to MMF, and may increase the risk of delayed onset muscle soreness (DOMS) and/or injury due to technical breakdown. In contrast, there is some evidence that suggests training to a slightly less intensity (i.e., within 1-4 repetitions in reserve [RIR]) may result in comparable hypertrophic results with less of a physical and psychological demand on participants.
For these reasons, this study looks to investigate if an easier (i.e., less intense) approach to training such as training with repetitions in reserve (RIR), warrants similar or better muscle hypertrophy adaptations to MMF.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups (train to failure OR train to non-failure) and stratified according to their recent training experience (beginner [3-9 months experience], intermediate [9-18 months experience], advanced [>18 months experience]).
| Arm | Type | Receives |
|---|---|---|
| Train to failure | Active comparator | Other: Resistance Training ProgramTraining regime will be highly uncomfortable since it will be both physically and psychologically challenging to push to momentary muscular fatigue (MMF; i.e., failure). |
| Train to non-failure | Active comparator | Other: Resistance Training ProgramTraining regime will be moderately uncomfortable as participants will be training at a close proximity to failure (4-0 repetitions in reserve; i.e., non-failure). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- biological male
- age 18 years or older
- enrolled at Dalhousie university
- minimum 3-months of consistent (at least 2x/week) resistance training experience
Key exclusion criteria (2 listed)
- body fat percentage 25% or greater (obese)
- use of performance enhancing drugs that aim to increase rate of muscle growth (i.e., androgenic steroids, anabolic steroids, selective androgen receptive modulators, growth hormone).
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 |
|---|---|---|
| Resistance Training ProgramParticipants will undergo a high exertion machine-based resistance training protocol. | Other | Train to failure, Train to non-failure |
Primary outcome
Segment girth (cm)
Time frame: 8-weeks
Upper arm (biceps) circumference, mid-thigh (quadriceps) circumference, waist (abdomen) circumference
2 secondary outcomes
Body composition (kg)
Time frame: 8-weeks
Body Fat Percentage
Time frame: 8-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 15 Aug 2023.
- Individual participant dataSharing planned: No
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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 Resistance Training Program in people with Hypertrophy and Body Weight Changes, run by Dalhousie 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 2 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 15 Aug 2023. 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?
Segment girth (cm) (time frame: 8-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 15 Aug 2023.