ObesityPSYCHENDOFITNCT04793451
Endurance-strength Training in Obese Women
A study testing Endurance training and Endurance-strength training in people with Obesity and Cognitive Dysfunction, 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 selected psychological aspects 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, Cognitive Dysfunction, Physical Exercise
- 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 arterial hypertension
- mean systolic blood pressure > 140 mmHg and/or mean diastolic blood pressure > 90 mmHg;
- diabetes;
- ischemic heart disease;
- stroke;
- heart failure;
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- 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 Treatment of Obesity, Metabolic Disorders and Clinical Dietetics; Poznan University of Medical Sciences
Poznan, Wielkopolska, 60-569
About this study
Official title: Effect of Endurance and Endurance-strength Training on Selected Aspects of Psychological Functioning of Women With Obesity
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.
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, anthropometric measurements were performed and psychological questionnaires (Perceived Stress Scale (PSS-10); The Rosenberg Self-Esteem Scale (SES); Body Shape Questionnaire (BSQ - 34); Figure rating scale (FRS); The Three-Factor Eating Questionnaire-18 (TFEQ-18)) were fulfilled 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, Cognitive Dysfunction, Physical Exercise
- Being tested
- Endurance training, Endurance-strength training
- Keywords
- Obesity, Women, Psychological functioning, Physical exercise
- Medical subject headings
- Obesity, Cognitive Dysfunction, Motor Activity
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.
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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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"?
Measured: 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"?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: after three months of physical training
Secondary outcomes (142)
The Rosenberg Self-Esteem Scale (SES) question 1 at Baseline
On the whole, I am satisfied with myself.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 1 after three months of physical training
On the whole, I am satisfied with myself.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 2 at Baseline
At times, I think I am no good at all.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 2 after three months of physical training
At times, I think I am no good at all.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 3 at Beseline
I feel that I have a number of good qualities.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 3 after three months of physical training
I feel that I have a number of good qualities.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 4 at Baseline
I am able to do things as well as most other people.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 4 at Baseline
I am able to do things as well as most other people.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 5 at Baseline
I feel I do not have much to be proud of.
Measured: At the baseline
The Rosenberg Self-Esteem Scale (SES) question 5 after three months of physical training
I feel I do not have much to be proud of.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 6 at Baseline
I certainly feel useless at times.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 6 after three months of physical training
I certainly feel useless at times.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 7 at Baseline
I feel that I'm a person of worth, at least on an equal plane with others.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 7 after three months of physical training
I feel that I'm a person of worth, at least on an equal plane with others.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 8 at Baseline
I wish I could have more respect for myself.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 8 after three months of physical training
I wish I could have more respect for myself.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 9 at Baseline
All in all, I am inclined to feel that I am a failure.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 9 after three months of physical training
All in all, I am inclined to feel that I am a failure.
Measured: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 10 at Baseline
I take a positive attitude toward myself.
Measured: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 10 after three months of physical training
I take a positive attitude toward myself.
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 1 at baseline
Has feeling bored made you brood about your shape?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 1 after three months of physical training
Has feeling bored made you brood about your shape?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 2 at baseline
Have you been so worried about your shape that you have been feeling you ought to diet?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 2 after three months of physical training
Have you been so worried about your shape that you have been feeling you ought to diet?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 3 at baseline
Have you thought that your thighs, hips or bottom are too large for the rest of you?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 3 after three months of physical training
Have you thought that your thighs, hips or bottom are too large for the rest of you?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 4 at baseline
Have you been afraid that you might become fat (or fatter)?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 4 after three months of physical training
Have you been afraid that you might become fat (or fatter)?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 5 at baseline
Have you worried about your flesh being not firm enough?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 5 after three months of physical training
Have you worried about your flesh being not firm enough?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 6 at baseline
Has feeling full (e.g. after eating a large meal) made you feel fat?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 6 after three months of physical training
Has feeling full (e.g. after eating a large meal) made you feel fat?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 7 at baseline
Have you felt so bad about your shape that you have cried?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 7 after three months of physical training
Have you felt so bad about your shape that you have cried?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 8 at baseline
Have you avoided running because your flesh might wobble?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 8 after three months of physical training
Have you avoided running because your flesh might wobble?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 9 at baseline
Has being with thin women made you feel self-conscious about your shape?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 9 after three months of physical training
Has being with thin women made you feel self-conscious about your shape?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 10 at baseline
Have you worried about your thighs spreading out when sitting down?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 10 after three months of physical training
Have you worried about your thighs spreading out when sitting down?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 11 at baseline
Has eating even a small amount of food made you feel fat?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 11 after three months of physical training
Has eating even a small amount of food made you feel fat?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 12 at baseline
Have you noticed the shape of other women and felt that your own shape compared unfavourably?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 12 after three months of physical training
Have you noticed the shape of other women and felt that your own shape compared unfavourably?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 13 at baseline
Has thinking about your shape interfered with your ability to concentrate (e.g. while watching television, reading, listening to conversations)?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 13 after three months of physical training
Has thinking about your shape interfered with your ability to concentrate (e.g. while watching television, reading, listening to conversations)?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 14 at baseline
Has being naked, such as when taking a bath, made you feel fat?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 14 after three months of physical training
Has being naked, such as when taking a bath, made you feel fat?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 15 at baseline
Have you avoided wearing clothes which make you particularly aware of the shape of your body?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 15 after three months of physical training
Have you avoided wearing clothes which make you particularly aware of the shape of your body?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 16 at baseline
Have you imagined cutting off fleshy areas of your body?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 16 after three months of physical training
Have you imagined cutting off fleshy areas of your body?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 17 at baseline
Has eating sweets, cakes, or other high calorie food made you feel fat?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 17 after three months of physical training
Has eating sweets, cakes, or other high calorie food made you feel fat?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 18 at baseline
Have you not gone out to social occasions (e.g. parties) because you have felt bad about your shape?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 18 after three months of physical training
Have you not gone out to social occasions (e.g. parties) because you have felt bad about your shape?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 19 at baseline
Have you felt excessively large and rounded?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 19 after three months of physical training
Have you felt excessively large and rounded?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 20 at baseline
Have you felt ashamed of your body?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 20 after three months of physical training
Have you felt ashamed of your body?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 21 at baseline
Has worry about your shape made you diet?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 21 after three months of physical training
Has worry about your shape made you diet?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 22 at baseline
Have you felt happiest about your shape when your stomach has been empty (e.g. in the morning)?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 22 after three months of physical training
Have you felt happiest about your shape when your stomach has been empty (e.g. in the morning)?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 23 at baseline
Have you thought that you are in the shape you are because you lack self-control?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 23 after three months of physical training
Have you thought that you are in the shape you are because you lack self-control?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 24 at baseline
Have you worried about other people seeing rolls of fat around your waist or stomach?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 24 after three months of physical training
Have you worried about other people seeing rolls of fat around your waist or stomach?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 25 at baseline
Have you felt that it is not fair that other women are thinner than you?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 25 after three months of physical training
Have you felt that it is not fair that other women are thinner than you?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 26 at baseline
Have you vomited in order to feel thinner?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 26 after three months of physical training
Have you vomited in order to feel thinner?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 27 at baseline
When in company have your worried about taking up too much room (e.g. sitting on a sofa, or a bus seat)?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 27 after three months of physical training
When in company have your worried about taking up too much room (e.g. sitting on a sofa, or a bus seat)?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 28 at baseline
Have you worried about your flesh being dimply?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 28after three months of physical training
Have you worried about your flesh being dimply?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 29 at baseline
Has seeing your reflection (e.g. in a mirror or shop window) made you feel bad about your shape?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 29 after three months of physical training
Has seeing your reflection (e.g. in a mirror or shop window) made you feel bad about your shape?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 30 at baseline
Have you pinched areas of your body to see how much fat there is?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 30 after three months of physical training
Have you pinched areas of your body to see how much fat there is?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 31 at baseline
Have you avoided situations where people could see your body (e.g. communal changing rooms or swimming baths)?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 31 after three months of physical training
Have you avoided situations where people could see your body (e.g. communal changing rooms or swimming baths)?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 32 at baseline
Have you taken laxatives in order to feel thinner?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 32 after three months of physical training
Have you taken laxatives in order to feel thinner?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 33 at baseline
Have you been particularly self-conscious about your shape when in the company of other people?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 33 after three months of physical training
Have you been particularly self-conscious about your shape when in the company of other people?
Measured: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 34 at baseline
Has worry about your shape made you feel you ought to exercise?
Measured: at baseline
Body Shape Questionnaire (BSQ - 34) question 34 after three months of physical training
Has worry about your shape made you feel you ought to exercise?
Measured: after three months of physical training
Figure rating scale (FRS) - figure 1 at baseline
Figure no. 1
Measured: at baseline
Figure rating scale (FRS) - figure 1 after three months of physical training
Figure no. 1
Measured: after three months of physical training
Figure rating scale (FRS) - figure 2 at baseline
Figure no. 2
Measured: at baseline
Figure rating scale (FRS) - figure 2 after three months of physical training
Figure no. 2
Measured: after three months of physical training
Figure rating scale (FRS) - figure 3 at baseline
Figure no. 3
Measured: at baseline
Figure rating scale (FRS) - figure 3 after three months of physical training
Figure no. 3
Measured: after three months of physical training
Figure rating scale (FRS) - figure 4 at baseline
Figure no. 4
Measured: at baseline
Figure rating scale (FRS) - figure 4 after three months of physical training
Figure no. 4
Measured: after three months of physical training
Figure rating scale (FRS) - figure 5 at baseline
Figure no. 5
Measured: at baseline
Figure rating scale (FRS) - figure 5 after three months of physical training
Figure no. 5
Measured: after three months of physical training
Figure rating scale (FRS) - figure 6 at baseline
Figure no. 6
Measured: at baseline
Figure rating scale (FRS) - figure 6 after three months of physical training
Figure no. 6
Measured: after three months of physical training
Figure rating scale (FRS) - figure 7 at baseline
Figure no. 7
Measured: at baseline
Figure rating scale (FRS) - figure 7 after three months of physical training
Figure no. 7
Measured: after three months of physical training
Figure rating scale (FRS) - figure 8 at baseline
Figure no. 8
Measured: at baseline
Figure rating scale (FRS) - figure 8 after three months of physical training
Figure no. 8
Measured: after three months of physical training
Figure rating scale (FRS) - figure 9 at baseline
Figure no. 9
Measured: at baseline
Figure rating scale (FRS) - figure 9 after three months of physical training
Figure no. 9
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 1 at baseline
When I smell a sizzling steak or juicy piece of meat, I find it very difficult to keep from eating, even if I have just finished a meal.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 1 after three months of physical training
When I smell a sizzling steak or juicy piece of meat, I find it very difficult to keep from eating, even if I have just finished a meal.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 2 at baseline
I deliberately take small helpings as a means of controlling my weight.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 2 after three months of physical training
I deliberately take small helpings as a means of controlling my weight.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 3 at baseline
When I feel anxious, I find myself eating.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 3 after three months of physical training
When I feel anxious, I find myself eating.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 4 at baseline
Sometimes when I start eating, I just can't seem to stop.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 4 after three months of physical training
Sometimes when I start eating, I just can't seem to stop.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 5 at baseline
Being with someone who is eating often makes me hungry enough to eat also.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 5 after three months of physical training
Being with someone who is eating often makes me hungry enough to eat also.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 6 at baseline
When I feel blue, I often overeat.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 6 after three months of physical training
When I feel blue, I often overeat.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 7 at baseline
When I see a real delicacy, I often get so hungry that I have to eat right away.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 7 after three months of physical training
When I see a real delicacy, I often get so hungry that I have to eat right away.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 8 at baseline
I get so hungry that my stomach often seems like a bottomless pit.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 8 after three months of physical training
I get so hungry that my stomach often seems like a bottomless pit.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 9 at baseline
I am always hungry so it is hard for me to stop eating before I finish the food on my plate.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 9 after three months of physical training
I am always hungry so it is hard for me to stop eating before I finish the food on my plate.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 10 at baseline
When I feel lonely, I console myself by eating.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 10 after three months of physical training
When I feel lonely, I console myself by eating.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 11 at baseline
I consciously hold back at meals in order not to weight gain.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 11after three months of physical training
I consciously hold back at meals in order not to weight gain.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 12 at baseline
I do not eat some foods because they make me fat.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 12 after three months of physical training
I do not eat some foods because they make me fat.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 13 at baseline
I am always hungry enough to eat at any time.
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 13 after three months of physical training
I am always hungry enough to eat at any time.
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 14 at baseline
How often do you feel hungry?
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 14 after three months of physical training
How often do you feel hungry?
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 15 at baseline
How frequently do you avoid "stocking up" on tempting foods?
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 15 after three months of physical training
How frequently do you avoid "stocking up" on tempting foods?
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 16 at baseline
How likely are you to consciously eat less than you want?
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 16 after three months of physical training
How likely are you to consciously eat less than you want?
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 17 at baseline
Do you go on eating binges though you are not hungry?
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 17 after three months of physical training
Do you go on eating binges though you are not hungry?
Measured: after three months of physical training
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 18 at baseline
On a scale of 1 to 8, where 1 means no restraint in eating (eating whatever you want, whenever you want it) and 8 means total restraint (constantly limiting food intake and never "giving in"), what number would you give yourself?
Measured: at baseline
The Three-Factor Eating Questionnaire-18 (TFEQ-18) question 18 after three months of physical training
On a scale of 1 to 8, where 1 means no restraint in eating (eating whatever you want, whenever you want it) and 8 means total restraint (constantly limiting food intake and never "giving in"), what number would you give yourself?
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 posted11 Mar 2021
- 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
- Sponsor
- Investigators
- Paweł Bogdański, Prof., Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793451
- Sponsor's protocol ID
- 753/13
- Acronym
- PSYCHENDOFIT
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and/or analysed during the study are planned to be available from the investigators on reasonable request.
Publications
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.
PubMed 34444714
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endurance and Endurance-strength Training on Selected Aspects of Psychological Functioning of Women With Obesity
- ClinicalTrials.gov ID
- NCT04793451
- Acronym / sponsor ID
- PSYCHENDOFIT / 753/13
- Conditions
- Obesity, Cognitive Dysfunction, Physical Exercise
- Keywords
- Obesity, Women, Psychological functioning, Physical exercise
- 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
- 11 Mar 2021 (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 selected psychological aspects 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, anthropometric measurements were performed and psychological questionnaires (Perceived Stress Scale (PSS-10); The Rosenberg Self-Esteem Scale (SES); Body Shape Questionnaire (BSQ - 34); Figure rating scale (FRS); The Three-Factor Eating Questionnaire-18 (TFEQ-18)) were fulfilled 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 (16 listed)
- secondary form of arterial hypertension
- mean systolic blood pressure > 140 mmHg and/or mean diastolic blood pressure > 90 mmHg;
- diabetes;
- ischemic heart disease;
- stroke;
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
Perceived Stress Scale (PSS-10) question 1 at Baseline
Time frame: at Baseline
In the last month, how often have you been upset because of something that happened unexpectedly?
Perceived Stress Scale (PSS-10) question 1 after three months of physical training
Time frame: after three months of physical training
In the last month, how often have you been upset because of something that happened unexpectedly?
Perceived Stress Scale (PSS-10) question 2 at Baseline
Time frame: at Baseline
In the last month, how often have you felt that you were unable to control the important things in your life?
Perceived Stress Scale (PSS-10) question 2 after three months of physical training
Time frame: 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?
Perceived Stress Scale (PSS-10) question 3 at Baseline
Time frame: at Baseline
In the last month, how often have you felt nervous and "stressed"?
Perceived Stress Scale (PSS-10) question 3 after three months of physical training
Time frame: after three months of physical training
In the last month, how often have you felt nervous and "stressed"?
Perceived Stress Scale (PSS-10) question 4 at Baseline
Time frame: at Baseline
In the last month, how often have you felt confident about your ability to handle your personal problems?
Perceived Stress Scale (PSS-10) question 4 after three months of physical training
Time frame: after three months of physical training
In the last month, how often have you felt confident about your ability to handle your personal problems?
Perceived Stress Scale (PSS-10) question 5 at Baseline
Time frame: at Baseline
In the last month, how often have you felt that things were going your way?
Perceived Stress Scale (PSS-10) question 5 after three months of physical training
Time frame: after three months of physical training
In the last month, how often have you felt that things were going your way?
Perceived Stress Scale (PSS-10) question 6 at Baseline
Time frame: 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?
Perceived Stress Scale (PSS-10) question 6 after three months of physical training
Time frame: 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?
Perceived Stress Scale (PSS-10) question 7 at Baseline
Time frame: at Baseline
In the last month, how often have you been able to control irritations in your life?
Perceived Stress Scale (PSS-10) question 7 after three months of physical training
Time frame: after three months of physical training
In the last month, how often have you been able to control irritations in your life?
Perceived Stress Scale (PSS-10) question 8 at Baseline
Time frame: at Baseline
In the last month, how often have you felt that you were on top of things?
Perceived Stress Scale (PSS-10) question 8 after three months of physical training
Time frame: after three months of physical training
In the last month, how often have you felt that you were on top of things?
Perceived Stress Scale (PSS-10) question 9 at Baseline
Time frame: at Baseline
In the last month, how often have you been angered because of things that were outside of your control?
Perceived Stress Scale (PSS-10) question 9 after three months of physical training
Time frame: 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?
Perceived Stress Scale (PSS-10) question 10 at Baseline
Time frame: at Baseline
In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?
Perceived Stress Scale (PSS-10) question 10 after three months of physical training
Time frame: 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?
142 secondary outcomes
The Rosenberg Self-Esteem Scale (SES) question 1 at Baseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 1 after three months of physical training
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 2 at Baseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 2 after three months of physical training
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 3 at Beseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 3 after three months of physical training
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 4 at Baseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 4 at Baseline
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 5 at Baseline
Time frame: At the baseline
The Rosenberg Self-Esteem Scale (SES) question 5 after three months of physical training
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 6 at Baseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 6 after three months of physical training
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 7 at Baseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 7 after three months of physical training
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 8 at Baseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 8 after three months of physical training
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 9 at Baseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 9 after three months of physical training
Time frame: after three months of physical training
The Rosenberg Self-Esteem Scale (SES) question 10 at Baseline
Time frame: at Baseline
The Rosenberg Self-Esteem Scale (SES) question 10 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 1 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 1 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 2 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 2 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 3 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 3 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 4 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 4 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 5 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 5 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 6 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 6 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 7 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 7 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 8 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 8 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 9 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 9 after three months of physical training
Time frame: after three months of physical training
Body Shape Questionnaire (BSQ - 34) question 10 at baseline
Time frame: at baseline
Body Shape Questionnaire (BSQ - 34) question 10 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 11 Mar 2021.
- Derived from this study: PubMed 34444714Bak-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.
- Individual participant dataSharing planned: No. The datasets generated during and/or analysed during the study are planned to be available from the investigators on reasonable request.
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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.
Paweł Bogdański, Prof. study chair
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 and Cognitive Dysfunction, 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 16 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 11 Mar 2021. 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?
Perceived Stress Scale (PSS-10) question 1 at Baseline (time frame: at Baseline). The study lists 20 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 NCT04793451, 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 11 Mar 2021.