NCT04793451

Brief Summary

The aim of this study was to compare the effects of three months' endurance training and three months' endurance-strength training on selected psychological aspects 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
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

5 years

First QC Date

March 8, 2021

Last Update Submit

March 10, 2021

Conditions

Keywords

ObesityWomenPsychological functioningPhysical exercise

Outcome Measures

Primary Outcomes (20)

  • Perceived Stress Scale (PSS-10) question 1 at Baseline

    In the last month, how often have you been upset because of something that happened unexpectedly?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 1 after three months of physical training

    In the last month, how often have you been upset because of something that happened unexpectedly?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 2 at Baseline

    In the last month, how often have you felt that you were unable to control the important things in your life?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 2 after three months of physical training

    In the last month, how often have you felt that you were unable to control the important things in your life?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 3 at Baseline

    In the last month, how often have you felt nervous and "stressed"?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 3 after three months of physical training

    In the last month, how often have you felt nervous and "stressed"?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 4 at Baseline

    In the last month, how often have you felt confident about your ability to handle your personal problems?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 4 after three months of physical training

    In the last month, how often have you felt confident about your ability to handle your personal problems?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 5 at Baseline

    In the last month, how often have you felt that things were going your way?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 5 after three months of physical training

    In the last month, how often have you felt that things were going your way?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 6 at Baseline

    In the last month, how often have you found that you could not cope with all the things that you had to do?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 6 after three months of physical training

    In the last month, how often have you found that you could not cope with all the things that you had to do?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 7 at Baseline

    In the last month, how often have you been able to control irritations in your life?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 7 after three months of physical training

    In the last month, how often have you been able to control irritations in your life?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 8 at Baseline

    In the last month, how often have you felt that you were on top of things?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 8 after three months of physical training

    In the last month, how often have you felt that you were on top of things?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 9 at Baseline

    In the last month, how often have you been angered because of things that were outside of your control?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 9 after three months of physical training

    In the last month, how often have you been angered because of things that were outside of your control?

    after three months of physical training

  • Perceived Stress Scale (PSS-10) question 10 at Baseline

    In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?

    at Baseline

  • Perceived Stress Scale (PSS-10) question 10 after three months of physical training

    In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?

    after three months of physical training

Secondary Outcomes (142)

  • The Rosenberg Self-Esteem Scale (SES) question 1 at Baseline

    at Baseline

  • The Rosenberg Self-Esteem Scale (SES) question 1 after three months of physical training

    after three months of physical training

  • The Rosenberg Self-Esteem Scale (SES) question 2 at Baseline

    at Baseline

  • The Rosenberg Self-Esteem Scale (SES) question 2 after three months of physical training

    after three months of physical training

  • The Rosenberg Self-Esteem Scale (SES) question 3 at Beseline

    at Baseline

  • +137 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 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics; Poznan University of Medical Sciences

Poznan, Wielkopolska, 60-569, Poland

Location

Related Publications (1)

  • Bak-Sosnowska M, Gruszczynska M, Skrypnik D, Grzegorczyn S, Karolkiewicz J, Ratajczak M, Madry E, Walkowiak J, Bogdanski P. Type of Physical Training and Selected Aspects of Psychological Functioning of Women with Obesity: A Randomised Trial. Nutrients. 2021 Jul 26;13(8):2555. doi: 10.3390/nu13082555.

MeSH Terms

Conditions

ObesityCognitive DysfunctionMotor Activity

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Paweł Bogdański, Prof.

    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
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

December 6, 2012

Primary Completion

December 1, 2017

Study Completion

December 30, 2017

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

The datasets generated during and/or analysed during the study are planned to be available from the investigators on reasonable request.

Locations