NCT02179307

Brief Summary

The literature is not clear as to which training volume to employ during initial phases of resistance training programs to ensure optimal muscular adaptations. The purpose of this study is therefore to compare effects of strength training with low versus moderate volume on muscular function and hypertrophy in previously untrained, healthy individuals. Furthermore, the investigators will relate individual variation in responses to proxy markers of individual training state, such as baseline muscular function and muscle fiber type. The study will include 25 women and 25 men and will consist of a 12-week resistance training protocol. Each study participant will act as their own control, performing both the low- (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or non-dominant leg, in a stratified and randomized fashion. Primary outcome measures are thigh muscle cross section area and unilateral knee extension strength. Additionally, muscle fiber type composition will be evaluated as well as additional parameters of muscular function. The primary hypothesis is that low-volume protocols will be beneficial for individuals with glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more aerobic phenotypes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

June 27, 2014

Last Update Submit

November 5, 2015

Conditions

Keywords

muscle hypertrophystrengthresistance trainingexercisephysical fitnesshealthphysical conditioning

Outcome Measures

Primary Outcomes (2)

  • Thigh muscle cross-sectional area

    Changes in muscle cross sectional area of each thigh from baseline to post intervention, assessed by MRI.

    Week 0 (baseline) and 12 (post training intervention)

  • Unilateral knee-extension isometric strength

    Time course changes in maximum knee extensor, isometric strength evaluated at 120° knee angle (180° fully extended).

    Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)

Secondary Outcomes (6)

  • Muscle strength

    Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)

  • Knee extensors and flexors force-velocity relationship

    Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)

  • Blood hormonal profiles

    Week 0 (baseline), 2 and 12 (post training intervention)

  • Muscle fiber cross-sectional area

    Week 0 (baseline), 2 and 12 (post training intervention)

  • Protein expression

    Week 0 (baseline), 2 and 12 (post training intervention)

  • +1 more secondary outcomes

Other Outcomes (3)

  • Body composition changes

    Week 0 (baseline) and 12 (post training intervention)

  • Habitual physical activity

    Week 0

  • Daily nutrient intake

    Week 6

Study Arms (1)

Arm label 1-Set, 3-Set

EXPERIMENTAL

12-week progressive strength training protocol of different volumes

Behavioral: 12-week progressive strength training protocol

Interventions

Every study participant will complete 12 weeks of progressive strength training with one leg performing 1-set per exercise per session and the contralateral leg performing 3-sets per exercise per session. Allocation of dominant/non-dominant leg to either 1- or 3-set protocol will be done in a stratified, randomized fashion (stratified with regard to sex and baseline strength).

Arm label 1-Set, 3-Set

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Non-smoking
  • Able to tolerate resistance exercise training

You may not qualify if:

  • Presence or history of cardiovascular, metabolic, endocrine or neuromuscular disease
  • Diagnosed mental health disorder
  • Intolerance to local anesthetic
  • No experience with exercise training
  • Performing regular resistance training (more than 1 session per week during last 12 months)
  • Impaired strength/ neuromuscular function due to previous injury
  • Recurrent pain in lower back, knee or shoulders
  • Taking prescribed medication that may affect outcome of training intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lillehammer University College

Lillehammer, Norway

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stian Ellefsen, PhD

    Inland Norway University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2014

First Posted

July 1, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations