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Strength Training Adaptations, Age and Genes (STAGE)

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ClinicalTrials.gov Identifier: NCT02589990
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Telemark University College

Tracking Information
First Submitted Date  ICMJE September 24, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date September 28, 2018
Study Start Date  ICMJE January 2016
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
Maximal muscle strength measured by 1 RM leg press in leg press machine [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02589990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • Blood sample will be collected to assess gene types Alpha Actinin 3, Angiotensin Converting Enzyme, Angiotensinogen [ Time Frame: 8 weeks ]
  • rate of force development in leg press measured by MuscleLab (Ergotest Tech., Langesund Norway) [ Time Frame: 8 weeks ]
  • agility will be measured by counter movement jump using the MuscleLab system by Ergotest Tech. (Langesund, Norway) [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strength Training Adaptations, Age and Genes
Official Title  ICMJE Effect of Maximal Strength Training in Relation to Age and Genes
Brief Summary The study investigates the effect of maximal strength training on muscular strength and power in different age groups from 20 to 80 year old. It also relates the training adaptations to different known genes such as angiotensin I-converting enzyme (ACE) and Alpha-actinin-3 (ACTN3). Participants will complete an eight weeks, three times per week training intervention of maximal strength training with a pre-post design. In addition, blood samples will be collected for the analyses of genetic variances.
Detailed Description

Aim: The study aims to investigate the effect of age and genes on training adaptations to a maximal strength training intervention.

Methods: Participants will be recruited through invitations at work places and other community arenas. The investigators aim to recruit 10-15 subjects in each of the following age groups: 20-29, 30-39, 40-49, 50-59, 60-69 and 70-80 years of age. Both genders will be included. All age groups will be matched for age-related baseline maximal strength and distribution between the two genders. All participants will be checked via a health registration scheme, and excluded if contra indications for hard physical training or testing should appear. When in doubt, the projects physician will decide on inclusion or exclusion due to a thorough examination. Subjects will give a blood sample to be analyzed for known genes such as ACE and ACTN3. The intervention has a pre- post design. Tests of maximal strength and power will be conducted in a leg-press machine, using the protocol assessing one repetition maximum (1RM) previously described. Force and Power will be measured by the Muscle Lab system from Ergotest Tech. (Langesund, Norway). The intervention is an eight week, three times per week protocol, each training session consisting of a standardized warm-up, and 4 repetitions x 4 sets with an intensity of 4 repetition maximum (4RM) performed in the leg press machine.There will be a three minutes pause between sets. Participants will be given instructions and supervision.

Hypothesis: Maximal strength training adaptations will be affected by age and baseline maximal strength but not by gender or genetic variations.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Healthy
Intervention  ICMJE Behavioral: Strength training
see arm description
Study Arms  ICMJE Experimental: Strength training
Strength training, 4 rep of 4RM x 4 sets in leg press.
Intervention: Behavioral: Strength training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2018)
76
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
90
Actual Study Completion Date  ICMJE September 3, 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults 20 to 90 years old

Exclusion Criteria:

  • Contraindications to maximum strength training and testing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02589990
Other Study ID Numbers  ICMJE STAGE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Telemark University College
Study Sponsor  ICMJE Telemark University College
Collaborators  ICMJE Norwegian University of Science and Technology
Investigators  ICMJE
Study Chair: Øyvind Støren, PhD Telemark University College
Study Director: Mona Sæbø, PhD Telemark University College
PRS Account Telemark University College
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP