Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity (ENDOFIT)

February 18, 2018 updated by: Pawel Bogdanski, Poznan University of Medical Sciences
The aim of this study was to compare the effects of three months' endurance training and three months' endurance-strength training on inflammatory markers in women with abdominal obesity.

Study Overview

Detailed Description

Study patients. Written informed consent was obtained from all subjects. The study meets the standards of the Declaration of Helsinki in its revised version of 1975 and its amendments of 1983, 1989, and 1996.

Study design. The study was designed as a prospective randomized trial. Subjects were randomly divided into two groups, A and B, using a randomization list. Both groups performed three month of physical training. Group A underwent endurance training, while group B performed endurance-strength training. Aside from the training, all subjects were instructed to maintain the physical activity and diet that they had been practicing so far. At baseline and after three months of physical training, blood samples for laboratory analyses were taken, anthropometric measurements were performed for both groups.

Intervention. The exercise program lasted three months, with three sessions per week. Women in both groups participated in a total of 36 training sessions. The women in group A underwent endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA). Exercise sessions consisted of a five-minute warm-up (stretching exercise) at low intensity (50%-60% of maximum heart rate), a 45-minute exercise (at 50%-80% of maximum heart rate), five minutes of cycling without a load, and five minutes of closing stretching and breathing exercise of low intensity. Group B performed endurance-strength exercise consisting of a five-minute warm-up (stretching exercises) of low intensity (50%-60% of maximum heart rate), a strength component, an endurance component, 5 minutes cycling without a load, and a 5 minutes closing stretching and breathing exercise of low intensity. The 20-minute-long strength component was performed using a neck barbell and a gymnastic ball. Directly after the strength exercise, the women took part in a 25-minute endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA) at 50%-80% of maximum heart rate. Both the endurance and endurance-strength training were comparable in exercise volume; the only difference was the nature of the effort.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Poznan, Poland, 60-569
        • Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • informed written consent;
  • simple obesity;
  • age from 18 to 65 years;
  • body fat content, assessed by electrical bioimpedance, equal to or more than 33%;
  • waist circumference more than 80 cm;
  • stable body weight in the one month prior to the trial.

Exclusion Criteria:

  • secondary form of excess body mass
  • secondary form of arterial hypertension
  • mean systolic blood pressure > 140 mmHg and/or mean diastolic blood pressure > 90 mmHg;
  • diabetes;
  • ischemic heart disease;
  • stroke;
  • heart failure;
  • history of malignancy;
  • clinically significant heart arrhythmias;
  • a history of use of any dietary supplement;
  • serious liver or kidney damage;
  • abnormal thyroid gland function;
  • clinically significant inflammation, connective tissue disease, or arthritis;
  • nicotine, alcohol, or narcotic abuse;
  • infection;
  • pregnancy, childbirth, or lactation;
  • any other condition that would make participation not in the best interest of the subject, or could prevent the efficacy of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Endurance training
The women in group A underwent endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA). Exercise sessions consisted of a five-minute warm-up (stretching exercise) at low intensity (50%-60% of maximum heart rate), a 45-minute exercise (at 50%-80% of maximum heart rate), five minutes of cycling without a load, and five minutes of closing stretching and breathing exercise of low intensity.
Experimental: Group B
Endurance-strength training
Group B performed endurance-strength exercise consisting of a five-minute warm-up (stretching exercises) of low intensity (50%-60% of maximum heart rate), a strength component, an endurance component, 5 minutes cycling without a load, and a 5 minutes closing stretching and breathing exercise of low intensity. The 20-minute-long strength component was performed using a neck barbell and a gymnastic ball. Directly after the strength exercise, the women took part in a 25-minute endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA) at 50%-80% of maximum heart rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein (CRP) at baseline
Time Frame: At baseline
Serum concentration of C-reactive protein at baseline
At baseline
CRP after three months of physical training
Time Frame: after three months of physical training
Serum concentration of C-reactive protein after three months of physical training
after three months of physical training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor necrosis factor alpha (TNFα) at baseline
Time Frame: at baseline
Serum concentration of tumor necrosis factor alpha at baseline
at baseline
TNFα after three months of physical training
Time Frame: after three months of physical training
Serum concentration of tumor necrosis factor alpha after three months of physical training
after three months of physical training
soluble receptor 2 of TNF alpha (sTNF R2) at baseline
Time Frame: At baseline
Serum concentration of soluble receptor 2 of TNF alpha at baseline
At baseline
sTNF R2 after three months of physical training
Time Frame: after three months of physical training
Serum concentration of soluble receptor 2 of TNF alpha after three months of physical training
after three months of physical training
interleukin 6 (IL-6) at baseline
Time Frame: At baseline
Serum concentration of interleukin 6 at baseline
At baseline
IL-6 after three months of physical training
Time Frame: after three months of physical training
Serum concentration of interleukin 6 after three months of physical training
after three months of physical training
interleukin 1 (IL-1) at baseline
Time Frame: At baseline
Serum concentration of interleukin 1 at baseline
At baseline
IL-1 after three months of physical training
Time Frame: after three months of physical training
Serum concentration of interleukin 1 after three months of physical training
after three months of physical training
visfatin at baseline
Time Frame: At baseline
Serum concentration of visfatin at baseline
At baseline
visfatin after three months of physical training
Time Frame: after three months of physical training
Serum concentration of visfatin after three months of physical training
after three months of physical training
Body mass at baseline
Time Frame: At baseline
Body mass at baseline
At baseline
Body mass after three months of physical training
Time Frame: after three months of physical training
Body mass after three months of physical training
after three months of physical training
Body height at baseline
Time Frame: At baseline
Body height at baseline
At baseline
Body height after three months of physical training
Time Frame: after three months of physical training
Body height after three months of physical training
after three months of physical training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Pawel Bogdanski, Prof., Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

February 18, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 18, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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