ClinicalTrials.gg
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

From the registry’s dates

  • Registered 5 years 2 months after the study started (first participant enrolled Dec 2012, registered Feb 2018).
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

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 38 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ;
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

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.

06

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

07

Study locations

1 site
  • Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
    Poznan, 60-569, Poland
08

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2012 to primary completion in Dec 2017, 59 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 59 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 23, 2018
StartActual
Dec 6, 2012
Primary completionActual
Dec 1, 2017
CompletionActual
Dec 30, 2017
Last update
Feb 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03444207
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
View the source record on ClinicalTrials.gov ↗

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