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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Poland
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Endurance training
Behavioral: 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
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1077/12; 753/13

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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