Examining Changes in Muscle Size and Body Composition Bet... | NCT05667233

Studies
Examining Changes in Muscle Size and Body Composition Between Two Hypertrophy Resistance Training Programs in Males

NCT05667233

Sponsor

Dalhousie University

Status

Completed

Last Update Posted

Aug 15, 2023Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Hypertrophy
Body Weight Changes
Muscle Size

Interventions

Resistance Training Program

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2023Actual

Primary Completion Date

Mar 27, 2023Actual

Completion Date

Apr 3, 2023Actual

First Submitted Date

Dec 19, 2022

First Submission Date that Met QC Criteria

Dec 19, 2022

First Posted Date

Dec 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2023

Last Update Posted Date

Aug 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeffery Zahavich, PhD, Instructor, Kinesiology, Dalhousie UniversityPrincipal Investigator

Lead Sponsor

Dalhousie UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).	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).	Other: Resistance Training Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistance Training Program	Other	Participants will undergo a high exertion machine-based resistance training protocol.	Train to failure Train to non-failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Segment girth (cm)	Upper arm (biceps) circumference, mid-thigh (quadriceps) circumference, waist (abdomen) circumference	8-weeks

Secondary Outcomes

Measure	Description	Time Frame
Body composition (kg)	Fat mass, Fat-free mass, Total Body Mass (fat mass + fat free mass)	8-weeks
Body Fat Percentage	Fat Mass (kg) / Total Body mass (kg) * 100

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

biological male
age 18 years or older
enrolled at Dalhousie university
minimum 3-months of consistent (at least 2x/week) resistance training experience

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dalplex Fitness Centre		Halifax	Nova Scotia	B3H 4R2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006984	Hypertrophy
D001836	Body Weight Changes
D009043	Motor Activity

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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]).