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Biological Adaptations of Strength Training.

D

Democritus University of Thrace

Status

Completed

Conditions

Non-Alcoholic Fatty Liver Disease

Treatments

Other: Control Trial
Other: Exercise Trial

Study type

Interventional

Funder types

Other

Identifiers

NCT04098484
EXERCISE-OBESITY-DUTH

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

35 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Normal-weight
Active Comparator group
Description:
Subjects with a BMI of 18-25 kg/m2
Treatment:
Other: Exercise Trial
Other: Control Trial
Obese
Experimental group
Description:
Subjects with a BMI of \> 30 kg/m2
Treatment:
Other: Exercise Trial
Other: Control Trial

Trial contacts and locations

1

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Central trial contact

Athanasios Chatzinikolaou, Associate Prof; Antonis Kampas, Prof

Data sourced from clinicaltrials.gov

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