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CompletedNCT03444207ENDOFITUpdated Feb 23, 2018

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

An interventional study of Endurance training and Endurance-strength training in Obesity, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • obesity
  • inflammation
  • C-reactive protein
  • training
  • tumor necrosis factor alfa
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Group A

    Endurance training

    Behavioral: Endurance training

  • Experimental
    Group B

    Endurance-strength training

    Behavioral: Endurance-strength training

Interventions

  • BehavioralEndurance 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.

  • BehavioralEndurance-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.

05

What researchers measure

Primary outcomes

  1. C-reactive protein (CRP) at baseline

    Serum concentration of C-reactive protein at baseline

    Time frame: At baseline

  2. CRP after three months of physical training

    Serum concentration of C-reactive protein after three months of physical training

    Time frame: after three months of physical training

Secondary outcomes

  1. tumor necrosis factor alpha (TNFα) at baseline

    Serum concentration of tumor necrosis factor alpha at baseline

    Time frame: at baseline

  2. TNFα after three months of physical training

    Serum concentration of tumor necrosis factor alpha after three months of physical training

    Time frame: after three months of physical training

  3. soluble receptor 2 of TNF alpha (sTNF R2) at baseline

    Serum concentration of soluble receptor 2 of TNF alpha at baseline

    Time frame: At baseline

  4. sTNF R2 after three months of physical training

    Serum concentration of soluble receptor 2 of TNF alpha after three months of physical training

    Time frame: after three months of physical training

  5. interleukin 6 (IL-6) at baseline

    Serum concentration of interleukin 6 at baseline

    Time frame: At baseline

  6. IL-6 after three months of physical training

    Serum concentration of interleukin 6 after three months of physical training

    Time frame: after three months of physical training

  7. interleukin 1 (IL-1) at baseline

    Serum concentration of interleukin 1 at baseline

    Time frame: At baseline

  8. IL-1 after three months of physical training

    Serum concentration of interleukin 1 after three months of physical training

    Time frame: after three months of physical training

  9. visfatin at baseline

    Serum concentration of visfatin at baseline

    Time frame: At baseline

  10. visfatin after three months of physical training

    Serum concentration of visfatin after three months of physical training

    Time frame: after three months of physical training

  11. Body mass at baseline

    Body mass at baseline

    Time frame: At baseline

  12. Body mass after three months of physical training

    Body mass after three months of physical training

    Time frame: after three months of physical training

  13. Body height at baseline

    Body height at baseline

    Time frame: At baseline

  14. Body height after three months of physical training

    Body height after three months of physical training

    Time frame: after three months of physical training

06

Study locations

1 site
  • Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
    Poznan, 60-569, Poland
07

References and documents

Publications

  • 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. PubMed 35627958 ↗
08

Registry details

Key details

Study ID
NCT03444207
Lead sponsor
Poznan University of Medical Sciences
Responsible party
Pawel Bogdanski (Professor, Poznan University of Medical Sciences) — Principal investigator
First posted
Feb 23, 2018
Start date
Dec 6, 2012
Primary completion
Dec 1, 2017
Completion
Dec 30, 2017
Last update
Feb 23, 2018

Study contacts

Pawel Bogdanski, Prof.
study chair · Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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