NCT03444207

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

5 years

First QC Date

February 13, 2018

Last Update Submit

February 18, 2018

Conditions

Keywords

obesityinflammationC-reactive proteintrainingtumor necrosis factor alfa

Outcome Measures

Primary Outcomes (2)

  • C-reactive protein (CRP) at baseline

    Serum concentration of C-reactive protein at baseline

    At baseline

  • 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 Outcomes (14)

  • tumor necrosis factor alpha (TNFα) at baseline

    at baseline

  • TNFα after three months of physical training

    after three months of physical training

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

    At baseline

  • sTNF R2 after three months of physical training

    after three months of physical training

  • interleukin 6 (IL-6) at baseline

    At baseline

  • +9 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Endurance training

Behavioral: Endurance training

Group B

EXPERIMENTAL

Endurance-strength training

Behavioral: Endurance-strength training

Interventions

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 A

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.

Group B

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences

Poznan, 60-569, Poland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityInflammation

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pawel Bogdanski, Prof.

    Department of Education and Obesity Treatment and Metabolic Disorders; Poznan University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The study was designed as a prospective randomized trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 23, 2018

Study Start

December 6, 2012

Primary Completion

December 1, 2017

Study Completion

December 30, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations