ObesityENDOFITNCT03444207
Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity
A study testing Endurance training and Endurance-strength training in people with Obesity, run by Poznan University of Medical Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Endurance training and Endurance-strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePoland
- Study dates
- 6 Dec 2012to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
Poznan, 60-569
About this study
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.
- Conditions
- Obesity
- Being tested
- Endurance training, Endurance-strength training
- Keywords
- obesity, inflammation, C-reactive protein, training, tumor necrosis factor alfa
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Endurance training Receives: Behavioral: Endurance training |
| Group B | Experimental | Endurance-strength training Receives: Behavioral: Endurance-strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein (CRP) at baseline
Serum concentration of C-reactive protein at baseline
Measured: At baseline
CRP after three months of physical training
Serum concentration of C-reactive protein after three months of physical training
Measured: after three months of physical training
Secondary outcomes (14)
tumor necrosis factor alpha (TNFα) at baseline
Serum concentration of tumor necrosis factor alpha at baseline
Measured: at baseline
TNFα after three months of physical training
Serum concentration of tumor necrosis factor alpha after three months of physical training
Measured: 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
Measured: 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
Measured: after three months of physical training
interleukin 6 (IL-6) at baseline
Serum concentration of interleukin 6 at baseline
Measured: At baseline
IL-6 after three months of physical training
Serum concentration of interleukin 6 after three months of physical training
Measured: after three months of physical training
interleukin 1 (IL-1) at baseline
Serum concentration of interleukin 1 at baseline
Measured: At baseline
IL-1 after three months of physical training
Serum concentration of interleukin 1 after three months of physical training
Measured: after three months of physical training
visfatin at baseline
Serum concentration of visfatin at baseline
Measured: At baseline
visfatin after three months of physical training
Serum concentration of visfatin after three months of physical training
Measured: after three months of physical training
Body mass at baseline
Body mass at baseline
Measured: At baseline
Body mass after three months of physical training
Body mass after three months of physical training
Measured: after three months of physical training
Body height at baseline
Body height at baseline
Measured: At baseline
Body height after three months of physical training
Body height after three months of physical training
Measured: after three months of physical training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start6 Dec 2012
- Primary completion1 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a prospective randomized trial.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Bogdanski, Poznan University of Medical Sciences
- Investigators
- Pawel Bogdanski, Prof., Study chair, Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444207
- Sponsor's protocol ID
- 1077/12; 753/13
- Acronym
- ENDOFIT
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT03444207
- Acronym / sponsor ID
- ENDOFIT / 1077/12; 753/13
- Conditions
- Obesity
- Keywords
- obesity, inflammation, C-reactive protein, training, tumor necrosis factor alfa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 6 Dec 2012 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was designed as a prospective randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Endurance trainingEndurance training |
| Group B | Experimental | Behavioral: Endurance-strength trainingEndurance-strength training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance trainingThe 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. | Behavioural | Group A |
| Endurance-strength trainingGroup 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. | Behavioural | Group B |
Primary outcome
C-reactive protein (CRP) at baseline
Time frame: At baseline
Serum concentration of C-reactive protein 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
14 secondary outcomes
tumor necrosis factor alpha (TNFα) at baseline
Time frame: at baseline
TNFα after three months of physical training
Time frame: after three months of physical training
soluble receptor 2 of TNF alpha (sTNF R2) at baseline
Time frame: At baseline
sTNF R2 after three months of physical training
Time frame: after three months of physical training
interleukin 6 (IL-6) at baseline
Time frame: At baseline
IL-6 after three months of physical training
Time frame: after three months of physical training
interleukin 1 (IL-1) at baseline
Time frame: At baseline
IL-1 after three months of physical training
Time frame: after three months of physical training
visfatin at baseline
Time frame: At baseline
visfatin after three months of physical training
Time frame: after three months of physical training
Body mass at baseline
Time frame: At baseline
Body mass after three months of physical training
Time frame: after three months of physical training
Body height at baseline
Time frame: At baseline
Body height after three months of physical training
Time frame: after three months of physical training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Derived from this study: PubMed 35627958Jamka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pawel Bogdanski, Prof. study chair
Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training and Endurance-strength training in people with Obesity, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein (CRP) at baseline (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.