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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02179307
Other study ID # Trainsome 2014#002
Secondary ID
Status Completed
Phase N/A
First received June 27, 2014
Last updated November 5, 2015
Start date August 2014
Est. completion date April 2015

Study information

Verified date November 2015
Source Lillehammer University College
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy

- Non-smoking

- Able to tolerate resistance exercise training

Exclusion Criteria:

- 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
12-week progressive strength training protocol
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).

Locations

Country Name City State
Norway Lillehammer University College Lillehammer

Sponsors (3)

Lead Sponsor Collaborator
Lillehammer University College Revmatismesykehuset AS, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Body composition changes Changes in body compositions (lean mass and fat mass) from prior intervention to after intervention assessed by dual x-ray absorptiometry scan. Week 0 (baseline) and 12 (post training intervention) No
Other Habitual physical activity Self-reported prior habitual physical activity assessed by questionnaire and interview before training intervention Week 0 No
Other Daily nutrient intake Daily nutrient intake assessed by a 4-day food intake registration. Week 6 No
Primary 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) No
Primary 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) No
Secondary Muscle strength Time course changes in maximum isoinertial strength defined by one-repetition maximum in leg press, knee extension, knee flexion, and bench press. Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention) No
Secondary Knee extensors and flexors force-velocity relationship Time course changes in torque measured during maximal voluntary isokinetic contraction at 60°, 120° and 240° · sec-1. Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention) No
Secondary Blood hormonal profiles Resting (week 0, 2 and 12) and acutely exercise-induced (week 2) hormonal profiles (testosterone, insulin-like growth factor 1, growth hormone and cortisol) determined in serum from venous blood samples. Week 0 (baseline), 2 and 12 (post training intervention) No
Secondary Muscle fiber cross-sectional area Changes in muscle fiber cross-sectional area assessed by immunohistochemistry from muscle biopsy. Determined from muscle biopsy samples (Vastus lateralis). Week 0 (baseline), 2 and 12 (post training intervention) No
Secondary Protein expression Changes in relative abundance of contractile protein isoforms (myosin heavy chain). Modification of proteins related to muscle hypertrophy in relation to an acute exercise session (assessed during week 2 of the intervention). Determined from muscle biopsy samples (Vastus lateralis). Week 0 (baseline), 2 and 12 (post training intervention) No
Secondary Gene expression Changes in gene expression related to skeletal muscle hypertrophy and structural phenotype measured in steady state conditions (biopsy sampled in resting conditions, week 0, 2 and 12) and in relation to acute exercise (biopsy sampled 1-h after strength exercise, week 2). Determined from muscle biopsy samples (Vastus lateralis). Week 0 (baseline), 2 and 12 (post training intervention) No
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