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Biological Adaptations of Strength Training.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098484
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Athanasios Chatzinikolaou, Democritus University of Thrace

Tracking Information
First Submitted Date  ICMJE September 19, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE April 2, 2019
Estimated Primary Completion Date December 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Changes in body composition [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Body composition will be assessed using Dual-energy-X-ray Absorptiometry (DXA) instrumentation
  • Changes in HDL concentration [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    HDL concentration will be measured in blood
  • Changes in LDL concentration [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    LDL concentration will be measured in blood
  • Changes in total cholesterol [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Total cholesterol levels will measured in blood
  • Changes in triglycerides [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Triglycerides concentration will be measured in blood
  • Changes in free fatty acids [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Free fatty acid concentration will be measured in blood
  • Changes in glucose [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Glucose concentration will be measured in blood
  • Changes in glycosylated hemoglobin [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Glycosylated hemoglobin levels will be meaasured in blood
  • Changes in insulin [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Isulin concentration will be measured in blood
  • Changes in insulin resistance index [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Insulin resistance index will be calculated through glucose and insulin values
  • Changes in White Blood Cells [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    White blood cells will be measured in bood samples
  • Changes in Red Blood Cells [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Red blood cells will be measured in bood samples
  • Changes in Hemoglobin [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Hemoglobin will be measured in blood samples
  • Changes in Hematocrit [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Hematocrit levels will be measured in blood samples
  • Changes in transaminases [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Transaminase levels will be measured in blood samples
  • Changes in C-reactive protein [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    C-reactive protein levels will be measured in blood samples
  • Changes in total antioxidant capacity [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Total antioxidant capacity will be assessed in plasma
  • Changes in glutathione [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Oxidized (GSH) and reduced (GSSG) glutathione will be measured in red blood cell lysate
  • Changes in protein carbonyls [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Protein carbonyl formation will be measured in serum
  • Changes in thiobarbituric acid reactive substances (TBARS) [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    TBARS will be measured in serum
  • Changes in catalase [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Catalase activity will be measured in serum
  • Changes in fatty infiltration of the liver [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Fatty infiltration of the liver will be assessed by ultrasound imaging of liver
  • Changes in bone status [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Bone mineral density and bone mineral content will be assessed in hole body, spine and hips using DXA
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Changes in body weight [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
  • Changes in muscle architecture [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Muscle architecture of quadriceps will be assessed by ultrasonography
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 Biological Adaptations of Strength Training.
Official Title  ICMJE Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men
Brief Summary A two-trial repeated measures design will be employed in this investigation. Both the control trial and the exercise trial will last for 3 months. During a week before the start of the study, participants will complete dietary recalls and record their habitual physical activity using accelerometers. Thereafter, body composition, ultrasound imaging of the muscle and liver, biochemical and hematological markers were measured. This range of measurements will be repeated the ended each month for both trials. Control trial succeeds exercise trial. An exercise intervention program will take place in the second trial, three times a week.
Detailed Description

A sample size of 30 volunteers, aged 35-45 years, will participate in the present study. Of them, 15 will be normal weight and 15 will suffer from fatty liver disease (BMI 29-35 kg/m2, waist size >102 cm). The exclusion criteria will be a) medication, b) musculoskeletal problems that will prevent participation in the training program, c) known condition or medical condition preventing participation in the program e.g. hypertension, d) BMI> 35kg / m2, (e) a severe family medical history up to first degree relatives with cardiovascular disease and / or diabetes at the age of less than 65 for women and less than 55 years for men and (f) smoking. After informing and receiving a questionnaire and medical history, volunteers will sign for their participation in the survey.

A two-trial repeated measures design will be applied in this investigation. Both control and exercise trials will last for 3 months. During the week preceding the commencement of the study, participants will complete dietary recalls and will have their habitual physical activity monitored, by utilizing accelerometers. Thereafter, body composition, ultrasound imaging of muscle and liver, biochemical and hematological markers will be measured. The same measurements will be repeated at the end of each month, in both trials. Control trial will be executed prior to exercise trial. An exercise intervention program, combining strength and cardiovascular exercises performed three times a week, will take place in the exercise trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fatty Liver Disease
Intervention  ICMJE
  • Other: Control Trial
    Participants will abstain from exercise throughout a 3-month period
  • Other: Exercise Trial
    Participants will execute a 3-month exercise training program
Study Arms  ICMJE
  • Active Comparator: Normal-weight
    Subjects with a BMI of 18-25 kg/m2
    Interventions:
    • Other: Control Trial
    • Other: Exercise Trial
  • Experimental: Obese
    Subjects with a BMI of > 30 kg/m2
    Interventions:
    • Other: Control Trial
    • Other: Exercise Trial
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 20, 2020
Estimated Primary Completion Date December 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • no use of medication
  • free of musculoskeletal limitations
  • absence of a known condition or medical condition preventing participation in the program (e.g. hypertension)
  • absence of a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men
  • non-smokers

Exclusion Criteria:

  • use of medication
  • musculoskeletal limitations that will prevent participation in the training program
  • known condition or medical condition preventing participation in the program (e.g. hypertension)
  • a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men
  • smoking
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Athanasios Chatzinikolaou, Associate Prof 0030 25310 39632 achatzin@phyed.duth.gr
Contact: Antonis Kampas, Prof 0030 25310 39643 akampas@phyed.duth.gr
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04098484
Other Study ID Numbers  ICMJE EXERCISE-OBESITY-DUTH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Athanasios Chatzinikolaou, Democritus University of Thrace
Study Sponsor  ICMJE Democritus University of Thrace
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Protopapa, PhDc Democritus University of Thrace, School of Physical Education and Sports Science
PRS Account Democritus University of Thrace
Verification Date September 2019

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