- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03444207
Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity (ENDOFIT)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Poznan, Poland, 60-569
- Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Study Chair: Pawel Bogdanski, Prof., Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1077/12; 753/13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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