- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02179307
Individual Response to Different Volumes of Resistance Training
Determinants of Intra-individual Variation in Adaptability to Resistance Training of Different Volumes
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Lillehammer, Noorwegen
- Lillehammer University College
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm label 1-Set, 3-Set
12-week progressive strength training protocol of different volumes
|
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).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Thigh muscle cross-sectional area
Tijdsspanne: Week 0 (baseline) and 12 (post training intervention)
|
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
Tijdsspanne: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
|
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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Muscle strength
Tijdsspanne: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
|
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)
|
|
Knee extensors and flexors force-velocity relationship
Tijdsspanne: Week 0 (baseline), 2, 5, 9 (during intervention) and 12 (after training intervention)
|
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)
|
|
Blood hormonal profiles
Tijdsspanne: Week 0 (baseline), 2 and 12 (post training intervention)
|
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)
|
|
Muscle fiber cross-sectional area
Tijdsspanne: Week 0 (baseline), 2 and 12 (post training intervention)
|
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)
|
|
Protein expression
Tijdsspanne: Week 0 (baseline), 2 and 12 (post training intervention)
|
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)
|
|
Gene expression
Tijdsspanne: Week 0 (baseline), 2 and 12 (post training intervention)
|
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)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body composition changes
Tijdsspanne: Week 0 (baseline) and 12 (post training intervention)
|
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)
|
|
Habitual physical activity
Tijdsspanne: Week 0
|
Self-reported prior habitual physical activity assessed by questionnaire and interview before training intervention
|
Week 0
|
|
Daily nutrient intake
Tijdsspanne: Week 6
|
Daily nutrient intake assessed by a 4-day food intake registration.
|
Week 6
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Stian Ellefsen, PhD, Inland Norway University of Applied Sciences
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Trainsome 2014#002
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .