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

Obesity Clinical Trial

— ENDOFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444207
• Other study ID #: 1077/12; 753/13
• Status: Completed
• Phase: N/A
• First received: February 13, 2018
• Last updated: February 18, 2018
• Start date: December 6, 2012
• Est. completion date: December 30, 2017

Study information

• Verified date: February 2018
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 30, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Abdominal

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein (CRP) at baseline	Serum concentration of C-reactive protein at baseline	At baseline
Primary	CRP 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	tumor necrosis factor alpha (TNFa) at baseline	Serum concentration of tumor necrosis factor alpha at baseline	at baseline
Secondary	TNFa 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
Secondary	soluble receptor 2 of TNF alpha (sTNF R2) at baseline	Serum concentration of soluble receptor 2 of TNF alpha at baseline	At baseline
Secondary	sTNF R2 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
Secondary	interleukin 6 (IL-6) at baseline	Serum concentration of interleukin 6 at baseline	At baseline
Secondary	IL-6 after three months of physical training	Serum concentration of interleukin 6 after three months of physical training	after three months of physical training
Secondary	interleukin 1 (IL-1) at baseline	Serum concentration of interleukin 1 at baseline	At baseline
Secondary	IL-1 after three months of physical training	Serum concentration of interleukin 1 after three months of physical training	after three months of physical training
Secondary	visfatin at baseline	Serum concentration of visfatin at baseline	At baseline
Secondary	visfatin after three months of physical training	Serum concentration of visfatin after three months of physical training	after three months of physical training
Secondary	Body mass at baseline	Body mass at baseline	At baseline
Secondary	Body mass after three months of physical training	Body mass after three months of physical training	after three months of physical training
Secondary	Body height at baseline	Body height at baseline	At baseline
Secondary	Body height after three months of physical training	Body height after three months of physical training	after three months of physical training