Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity (ENDOFIT)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Endurance training
Endurance-strength training
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring obesity, inflammation, C-reactive protein, training, tumor necrosis factor alfa
Eligibility Criteria
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.
Sites / Locations
- Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Endurance training
Endurance-strength training
Outcomes
Primary Outcome Measures
C-reactive protein (CRP) at baseline
Serum concentration of C-reactive protein at baseline
CRP after three months of physical training
Serum concentration of C-reactive protein after three months of physical training
Secondary Outcome Measures
tumor necrosis factor alpha (TNFα) at baseline
Serum concentration of tumor necrosis factor alpha at baseline
TNFα after three months of physical training
Serum concentration of tumor necrosis factor alpha after three months of physical training
soluble receptor 2 of TNF alpha (sTNF R2) at baseline
Serum concentration of soluble receptor 2 of TNF alpha at baseline
sTNF R2 after three months of physical training
Serum concentration of soluble receptor 2 of TNF alpha after three months of physical training
interleukin 6 (IL-6) at baseline
Serum concentration of interleukin 6 at baseline
IL-6 after three months of physical training
Serum concentration of interleukin 6 after three months of physical training
interleukin 1 (IL-1) at baseline
Serum concentration of interleukin 1 at baseline
IL-1 after three months of physical training
Serum concentration of interleukin 1 after three months of physical training
visfatin at baseline
Serum concentration of visfatin at baseline
visfatin after three months of physical training
Serum concentration of visfatin after three months of physical training
Body mass at baseline
Body mass at baseline
Body mass after three months of physical training
Body mass after three months of physical training
Body height at baseline
Body height at baseline
Body height after three months of physical training
Body height after three months of physical training
Full Information
NCT ID
NCT03444207
First Posted
February 13, 2018
Last Updated
February 18, 2018
Sponsor
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03444207
Brief Title
Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity
Acronym
ENDOFIT
Official Title
Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 6, 2012 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, inflammation, C-reactive protein, training, tumor necrosis factor alfa
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was designed as a prospective randomized trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Endurance training
Arm Title
Group B
Arm Type
Experimental
Arm Description
Endurance-strength training
Intervention Type
Behavioral
Intervention Name(s)
Endurance training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Endurance-strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
C-reactive protein (CRP) at baseline
Description
Serum concentration of C-reactive protein at baseline
Time Frame
At baseline
Title
CRP after three months of physical training
Description
Serum concentration of C-reactive protein after three months of physical training
Time Frame
after three months of physical training
Secondary Outcome Measure Information:
Title
tumor necrosis factor alpha (TNFα) at baseline
Description
Serum concentration of tumor necrosis factor alpha at baseline
Time Frame
at baseline
Title
TNFα after three months of physical training
Description
Serum concentration of tumor necrosis factor alpha after three months of physical training
Time Frame
after three months of physical training
Title
soluble receptor 2 of TNF alpha (sTNF R2) at baseline
Description
Serum concentration of soluble receptor 2 of TNF alpha at baseline
Time Frame
At baseline
Title
sTNF R2 after three months of physical training
Description
Serum concentration of soluble receptor 2 of TNF alpha after three months of physical training
Time Frame
after three months of physical training
Title
interleukin 6 (IL-6) at baseline
Description
Serum concentration of interleukin 6 at baseline
Time Frame
At baseline
Title
IL-6 after three months of physical training
Description
Serum concentration of interleukin 6 after three months of physical training
Time Frame
after three months of physical training
Title
interleukin 1 (IL-1) at baseline
Description
Serum concentration of interleukin 1 at baseline
Time Frame
At baseline
Title
IL-1 after three months of physical training
Description
Serum concentration of interleukin 1 after three months of physical training
Time Frame
after three months of physical training
Title
visfatin at baseline
Description
Serum concentration of visfatin at baseline
Time Frame
At baseline
Title
visfatin after three months of physical training
Description
Serum concentration of visfatin after three months of physical training
Time Frame
after three months of physical training
Title
Body mass at baseline
Description
Body mass at baseline
Time Frame
At baseline
Title
Body mass after three months of physical training
Description
Body mass after three months of physical training
Time Frame
after three months of physical training
Title
Body height at baseline
Description
Body height at baseline
Time Frame
At baseline
Title
Body height after three months of physical training
Description
Body height after three months of physical training
Time Frame
after three months of physical training
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pawel Bogdanski, Prof.
Organizational Affiliation
Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35627958
Citation
Jamka M, Piotrowska-Brudnicka SE, Karolkiewicz J, Skrypnik D, Bogdanski P, Cielecka-Piontek J, Sultanova G, Walkowiak J, Madry E. The Effect of Endurance and Endurance-Strength Training on Bone Health and Body Composition in Centrally Obese Women-A Randomised Pilot Trial. Healthcare (Basel). 2022 Apr 28;10(5):821. doi: 10.3390/healthcare10050821.
Results Reference
derived
Learn more about this trial
Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity
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