Biological Adaptations of Strength Training.

NCT ID: NCT04098484

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2023-10-31

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal-weight

Subjects with a BMI of 18-25 kg/m2

Group Type: ACTIVE_COMPARATOR

Control Trial

Intervention Type: OTHER

Participants will abstain from exercise throughout a 3-month period

Exercise Trial

Intervention Type: OTHER

Participants will execute a 3-month exercise training program

Obese

Subjects with a BMI of \> 30 kg/m2

Group Type: EXPERIMENTAL

Control Trial

Intervention Type: OTHER

Participants will abstain from exercise throughout a 3-month period

Exercise Trial

Intervention Type: OTHER

Participants will execute a 3-month exercise training program

Interventions

Control Trial

Participants will abstain from exercise throughout a 3-month period

Intervention Type: OTHER

Exercise Trial

Participants will execute a 3-month exercise training program

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: lead

Responsible Party

Athanasios Chatzinikolaou

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Protopapa, PhDc

Role: PRINCIPAL_INVESTIGATOR

Democritus University of Thrace, School of Physical Education and Sports Science

Locations

Democritus University of Thrace, School of Physical Education and Sports Science

Komotini, , Greece

Countries

Greece

Other Identifiers

EXERCISE-OBESITY-DUTH

Identifier Type: -

Identifier Source: org_study_id