ObesityNCT04456192
Effects of an Indoor Cycling Program on Cardio-Metabolic Factors in Women With Obesity and Normal Body Weight
A study testing Indoor Cycling Interval Exercise Training in people with Obesity and Dyslipidemias, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The aim of the research is to (1) evaluate the potential clinical effectiveness and biological mechanisms of indoor cycling in the treatment of obesity and (2) provide-up-to-date evidence on the impact of indoor cycling in reducing cardiovascular disease (CVD) risk factors, namely, hypertension, dyslipidemia, type 2… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dyslipidemias, Hypertension
- What is being tested?
- Indoor Cycling Interval Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2013to 15 Jun 2016
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Initial inclusion criteria for both study groups were as follows: age: 30 to 65 years and stable body weight in the month prior to the trial (permissible deviation ± 1 kg).
- For Women with Obesity Group: BMI ≥ 30 kg/m2; waist circumference > 80 cm. For Normal-weight Womeng Group: BMI ≤ 24.9 and ≥ 18.5 kg/m2
Who cannot join
- secondary form of obesity and/or secondary form of hypertension;
- diabetes mellitus;
- history of coronary artery disease;
- stroke;
- congestive heart failure;
- clinically significant arrhythmias or conduction disorders;
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- malignancy;
- poorly controlled hypertension (SBP > 140 mmHg and/or DBP > 90 mmHg), and/or modifications to antihypertensive treatment;
- lipid disorders requiring the implementation of drug treatment;
- clinically significant abnormalities in liver, kidney or thyroid gland function;
- clinically significant acute or chronic inflammatory process within the respiratory, digestive or genitourinary tracts, or the oral cavity, pharynx or paranasal sinuses; or, presence of connective tissue disease or arthritis;
- history of infection within the month prior to the study;
- nicotine, alcohol or drug abuse;
- and / or any other condition which, according to the researchers, would cause that participation would be detrimental to the participant or would prevent, limit or interfere with the results of the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education
Poznan, Greater Poland Voivodeship, 61-871
About this study
The aim of the research is to (1) evaluate the potential clinical effectiveness and biological mechanisms of indoor cycling in the treatment of obesity and (2) provide-up-to-date evidence on the impact of indoor cycling in reducing cardiovascular disease (CVD) risk factors, namely, hypertension, dyslipidemia, type 2 diabetes, endothelial dysfunction. We hypothesize that IC training, can be a good stimulus to mitigate cardiovascular risk factors in women with obesity and to improve values of the examined indicators towards that occurring in women with normal body weight.
The study was designed as a prospective exercise intervention trial. The study involved women with obesity (OW) and women with normal body weight (NW). Both study groups underwent the same 3-month physical training program. Outside the implemented program, all participants were instructed to maintain their normal physical activity, diet and not to use any dietary supplements. Dietary intake was assessed using interviews conducted at baseline and after completion of the trial. The amount of nutrients in participant's daily diet was processed and evaluated using a dietetics computer program. The intake of nutrients, total caloric intake during the study were constant in both groups. Anthropometric parameters, blood pressure and physical capacity were measured and blood samples were taken at baseline and after completion of the physical training program.
Read more
The study involved 31 obese or normal weight women aged 34-62. A total of 23 women with obesity (body mass index (BMI) ≥ 30 kg/m2; waist circumference > 80 cm) registered and screened from among 163 women at the outpatient clinic of the Department of Internal Medicine, Metabolic Disorders, and Hypertension, University of Medical Sciences, Poznań, Poland were enrolled to OW group. The NW group consisted of 8 healthy women from the announcement (BMI ≤ 24.9 and ≥ 18.5 kg/m2).
Informed consent was obtained from all participants, and the study was approved by the Ethics Committee of Poznan University of Medical Sciences (case no. 1077/12; supplement no. 753/13). The study conformed to all ethical issues included in the Helsinki Declaration.
The 3-month intervention consisted of a physical exercise program involving three indoor cycling sessions per week, with a total of 36 training sessions. Subjects exercised on cycle ergometers Schwinn® Evolution® (Schwinn Bicycle Company, Boulder, Colorado, USA). Each session lasted approximately 55 minutes. Training sessions consisted of a 5-min low-intensity warm-up (cycling at 50-65% of maximum heart rate (HRmax)), 40 min of main training at an intensity of 65-95% of HRmax, 5 min of non-weight-bearing cycling, finishing with 5 min of low-intensity cool-down stretching and breathing exercises.
Main part of the training was interval. Each exercise session consisted of 3 to 4 high intensity intervals with intensity exceeding 80% of HRmax, often reaching anaerobic threshold. High intensity intervals lasted approximately 4-minutes and were interspersed by recovery periods at 65-80% of HRmax.
HR during sessions was monitored with a Suunto Fitness Solution® device (Suunto, Vantaa, Finland). To ensure that assigned exercise intensities were obtained, the average per cent of the maximum heart rate during the entire training session was obtained from the device Blood samples for biochemical analyses were taken from a basilic vein, after overnight 12-hour fasting. In the serum samples, parameters were measured using commercially available enzyme-linked immunoassays.
Both before and after the whole training programme, the following measurements were made: body weight and height, BMI, waist and hip circumference, WHR, body composition (DXA), total-body skeletal muscle mass index, graded exercise test, isokinetic muscle strength of knee flexors and extensors, exercise and resting blood pressure, and the heart rate. Vascular endothelial function indices (eNOS, VEGF, TBARS and TAS) as well as TCH, LDL-C, HDL-C, TG, oxLDL and CRP of venous blood were determined.
A sample size was determined according to changes in VO2 peak. A total of 6 subjects in OW group and 7 subjects in NW group was calculated to yield at least 80% power of detecting an intervention effect as statistically significant at the 0.05 α level.
Read the detailed description
Anthropometric measurements were conducted with the subjects wearing light clothing and no shoes. Weight was measured to the nearest 0.1 kg and height to the nearest 0.5 cm. BMI was calculated as weight divided by height squared (kg/m2 ). Obesity was defined as BMI ≥ 30 kg/m2. Waist circumference (cm) was measured at the level of the iliac crest at the end of normal expiration. Hip circumference was measured at the maximum protuberance of the buttocks. Waist and hip circumferences were measured to the nearest 0.5 cm. Waist-to-hip ratio (WHR) was calculated as waist circumference divided by hip circumference. Index of central obesity (ICO) was calculated as waist circumference (cm) divided by height (cm) (Parikh, et al., 2012).
Body composition analysis was assessed using DXA (GE Healthcare Lunar Prodigy Advance; GE Medical Systems, Milan, Italy). The subjects were instructed not to make any intense physical effort in the 24h prior to the examination. The subjects were given complete instructions on the examination procedure. They wore cotton T-shirt, shorts, and socks and lay on the DXA table supine and motionlessly during the testing procedure. They were instructed to remove all metal, rubber, and plastic objects that might affect the X-ray beam. The same well-trained laboratory technician positioned the subjects, performed the scans, and executed the analysis according to the operator's manual, using the standard analysis protocol. Total body fat mass and lean body mass were determined using standard scan mode (in case of moderately obese subjects) or thick scan mode (in case of extremely obese subjects); the absorbed dose of radiation was 0.4 μGy and 0.8 μGy, respectively.
To determine the subjects' physical capacity, a Graded Exercise Test (GXT) was performed on an electronically braked cycle ergometer (Kettler ® DX1 Pro, Kettler, Ense, Germany). GXT began at a work rate of 25 W (60 rev/min). The work rate was incremented by 25 W every 2 min until the subject could no longer maintain the required pedal cadence. Each test lasted 4-14.5 min, depending on age and aerobic fitness status. The exercise tests were conducted between 8: 00 and 12: 00 a.m. in an air-conditioned laboratory, 2 h after consuming a light breakfast. Expired gases, minute ventilations (Ve), and heart rate (HR) during GXT were monitored continuously with an automated system (Oxycon Mobile ® ; Viasys Healthcare, Hoechberg, Germany). Oxygen intake (VO 2 ) and carbon dioxide output (VCO 2 ) was measured breath-by-breath and averaged over 15-second periods. Before each trial, the system was calibrated according to the manufacturer's instructions. Peak VO2 was defined as the highest 15-second averaged VO 2 obtained during the final exercise load on the test. HR peak (bpm) was measured as the highest 15-second average value in the test. To determine ventilatory threshold (VT), the V-slope method was administered using computerized regression analysis on the slopes of the CO 2 output versus O2 uptake plot, which detects the beginning of the excess CO 2 output generated from the buffering of H +. The method involves analyzing the behavior of VCO 2 as a function of VO 2 during GXT with a consequent increase in VCO 2 . This results in a transition in the relationship between VCO 2 and VO 2 . The software supplied by Viasys Healthcare was used, supported with a visual inspection on the part of an experienced researcher. As a secondary method, the ventilatory equivalent method (VEQ method) was employed and the point at which the equivalent for oxygen (VE/VO 2 ) increased without a concomitant rise in the equivalent for carbon dioxide (VE/VCO 2 ) was detected. The VT was expressed as a heart rate (HR VT ).
Exercise blood pressure was measured during a GXT using a digital electronic tensiometer (model 705IT TM, Omron Corporation, Kyoto, Japan). The measurement was taken during maximal work rate. Exercise HR was measured as the highest 15-second average value in the GXT. Resting blood pressure was measured fasting in the morning hours, in a sitting position with the legs uncrossed and the back and arm supported. Resting HR was measured under the same conditions, using auscultation of the heart by stethoscope. Regular or large adult cuffs were used, depending on the patient's arm circumference.
- Conditions
- Obesity, Dyslipidemias, Hypertension, Type 2 Diabetes, Endothelial Dysfunction
- Being tested
- Indoor Cycling Interval Exercise Training
- Keywords
- obesity, indoor cycling, interval physical training, cardio-metabolic factors
- Medical subject headings
- Obesity, Dyslipidemias, Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indoor Cycling Interval Exercise TrainingBehavioural
Also called Spinning Interval Physical Training
The 3-month intervention consisted of a physical exercise program involving three indoor cycling sessions per week, with a total of 36 training sessions. Subjects exercised on cycle ergometers Schwinn® Evolution® (Schwinn Bicycle Company, Boulder, Colorado, USA). Each session lasted approximately 55 minutes. Training sessions consisted of a 5-min low-intensity warm-up (cycling at 50-65% of maximum heart rate (HRmax)), 40 min of main training at an intensity of 65-95% of HRmax, 5 min of non-weight-bearing cycling, finishing with 5 min of low-intensity cool-down stretching and breathing exercises.
Main part of the training was interval. Each exercise session consisted of 3 to 4 high intensity intervals with intensity exceeding 80% of HRmax, often reaching anaerobic threshold. High intensity intervals lasted approximately 4-minutes and were interspersed by recovery periods at 65-80% of HRmax.
| Study group | Role | What they receive |
|---|---|---|
| Women with Obesity | Experimental | 23 healthy, obese (BMI ≥ 30 kg/m2; waist circumference > 80) women, aged 34-62, screened at the outpatient clinic of the Department of Internal Medicine, Metabolic Disorders, and Hypertension, University of Medical Sciences, Poznań, Poland were enrolled based on the inclusion criteria and the willingness to participate in the research. Receives: Behavioral: Indoor Cycling Interval Exercise Training |
| Normal-weight Women | Active comparator | 8 healthy, normal-weight (≤ 24.9 and ≥ 18.5 kg/m2) women, aged 34-62 were enrolled to intervention from the announcement.
Random selection for groups was not applicable due to the planned body mass difference in the studied groups. Receives: Behavioral: Indoor Cycling Interval Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]
Dimension Flex Reagent Cartridge
Measured: At baseline
Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]
Dimension Flex Reagent Cartridge
Measured: After three months of physical training
Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]
ELISA
Measured: At baseline
Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]
ELISA
Measured: After three months of physical training
Blood total antioxidant capacity (TAC) [mmolCRE/l]
ELISA
Measured: At baseline
Blood total antioxidant capacity (TAC) [mmolCRE/l]
ELISA
Measured: After three months of physical training
Thiobarbituric acid reactive substances (TBARS) [μmol/l]
ELISA
Measured: At baseline
Thiobarbituric acid reactive substances (TBARS) [μmol/l]
ELISA
Measured: After three months of physical training
Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]
ELISA
Measured: At baseline
Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]
ELISA
Measured: After three months of physical training
Vascular endothelial growth factor (VEGF) [pg/ml]
ELISA
Measured: At baseline
Vascular endothelial growth factor (VEGF) [pg/ml]
ELISA
Measured: After three months of physical training
C-reactive protein concentration (CRP) [mg/l]
ELISA
Measured: At baseline
C-reactive protein concentration (CRP) [mg/l]
ELISA
Measured: After three months of physical training
Secondary outcomes (12)
Body mass [kg]
Measured: At baseline
Body mass [kg]
Measured: After three months of physical training
Body height, waist circumference, hip circumference [cm]
Measured: At baseline
Body height, waist circumference, hip circumference [cm]
Measured: After three months of physical training
Body composition
Dual-energy X-ray Absorptiometry
Measured: At baseline
Body composition
Dual-energy X-ray Absorptiometry
Measured: After three months of physical training
Peak oxygen uptake (VO2 peak) [ml•min-1•kg-1]
Graded Exercise Test (GXT) with an automated system Oxycon Mobile ®
Measured: At baseline
Peak oxygen uptake (VO2 peak) [ml•min-1•kg-1]
Graded Exercise Test (GXT) with an automated system Oxycon Mobile ®
Measured: After three months of physical training
Resting heart rate [bpm], Peak heart rate [bpm], Ventilatory threshold heart rate [bpm],
Measured: At baseline
Resting heart rate [bpm], Peak heart rate [bpm], Ventilatory threshold heart rate [bpm],
Measured: After three months of physical training
Resting SBP [mmHg], Resting DBP [mmHg], Exercise SBP [mmHg], Exercise DBP [mmHg]
Measured: At baseline
Resting SBP [mmHg], Resting DBP [mmHg], Exercise SBP [mmHg], Exercise DBP [mmHg]
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 posted2 Jul 2020
- Study start1 Jan 2013
- Primary completion15 Jun 2016
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a prospective trial where two similar groups of women only differing in body mass participate in the same intervention.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Marzena Ratajczak, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456192
- Sponsor's protocol ID
- PoznanUPhyEd no. 2
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bianco A, Bellafiore M, Battaglia G, Paoli A, Caramazza G, Farina F, Palma A. The effects of indoor cycling training in sedentary overweight women. J Sports Med Phys Fitness. 2010 Jun;50(2):159-65.
PubMed 20585293Chavarrias M, Carlos-Vivas J, Collado-Mateo D, Perez-Gomez J. Health Benefits of Indoor Cycling: A Systematic Review. Medicina (Kaunas). 2019 Aug 8;55(8):452. doi: 10.3390/medicina55080452.
PubMed 31443139Damaso AR, da Silveira Campos RM, Caranti DA, de Piano A, Fisberg M, Foschini D, de Lima Sanches P, Tock L, Lederman HM, Tufik S, de Mello MT. Aerobic plus resistance training was more effective in improving the visceral adiposity, metabolic profile and inflammatory markers than aerobic training in obese adolescents. J Sports Sci. 2014;32(15):1435-45. doi: 10.1080/02640414.2014.900692. Epub 2014 Apr 14.
PubMed 24730354Ho SS, Radavelli-Bagatini S, Dhaliwal SS, Hills AP, Pal S. Resistance, aerobic, and combination training on vascular function in overweight and obese adults. J Clin Hypertens (Greenwich). 2012 Dec;14(12):848-54. doi: 10.1111/j.1751-7176.2012.00700.x. Epub 2012 Aug 20.
PubMed 23205751Su L, Fu J, Sun S, Zhao G, Cheng W, Dou C, Quan M. Effects of HIIT and MICT on cardiovascular risk factors in adults with overweight and/or obesity: A meta-analysis. PLoS One. 2019 Jan 28;14(1):e0210644. doi: 10.1371/journal.pone.0210644. eCollection 2019.
PubMed 30689632
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Indoor Cycling Program on Cardio-Metabolic Factors in Women With Obesity and Normal Body Weight
- ClinicalTrials.gov ID
- NCT04456192
- Acronym / sponsor ID
- PoznanUPhyEd no. 2
- Conditions
- Obesity, Dyslipidemias, Hypertension, Type 2 Diabetes, Endothelial Dysfunction
- Keywords
- obesity, indoor cycling, interval physical training, cardio-metabolic factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 2 Jul 2020 (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 the research is to (1) evaluate the potential clinical effectiveness and biological mechanisms of indoor cycling in the treatment of obesity and (2) provide-up-to-date evidence on the impact of indoor cycling in reducing cardiovascular disease (CVD) risk factors, namely, hypertension, dyslipidemia, type 2 diabetes, endothelial dysfunction. We hypothesize that IC training, can be a good stimulus to mitigate cardiovascular risk factors in women with obesity and to improve values of the examined indicators towards that occurring in women with normal body weight.
The study was designed as a prospective exercise intervention trial. The study involved women with obesity (OW) and women with normal body weight (NW). Both study groups underwent the same 3-month physical training program. Outside the implemented program, all participants were instructed to maintain their normal physical activity, diet and not to use any dietary supplements. Dietary intake was assessed using interviews conducted at baseline and after completion of the trial. The amount of nutrients in participant's daily diet was processed and evaluated using a dietetics computer program. The intake of nutrients, total caloric intake during the study were constant in both groups. Anthropometric parameters, blood pressure and physical capacity were measured and blood samples were taken at baseline and after completion of the physical training program.
The study involved 31 obese or normal weight women aged 34-62. A total of 23 women with obesity (body mass index (BMI) ≥ 30 kg/m2; waist circumference > 80 cm) registered and screened from among 163 women at the outpatient clinic of the Department of Internal Medicine, Metabolic Disorders, and Hypertension, University of Medical Sciences, Poznań, Poland were enrolled to OW group. The NW group consisted of 8 healthy women from the announcement (BMI ≤ 24.9 and ≥ 18.5 kg/m2).
Informed consent was obtained from all participants, and the study was approved by the Ethics Committee of Poznan University of Medical Sciences (case no. 1077/12; supplement no. 753/13). The study conformed to all ethical issues included in the Helsinki Declaration.
The 3-month intervention consisted of a physical exercise program involving three indoor cycling sessions per week, with a total of 36 training sessions. Subjects exercised on cycle ergometers Schwinn® Evolution® (Schwinn Bicycle Company, Boulder, Colorado, USA). Each session lasted approximately 55 minutes. Training sessions consisted of a 5-min low-intensity warm-up (cycling at 50-65% of maximum heart rate (HRmax)), 40 min of main training at an intensity of 65-95% of HRmax, 5 min of non-weight-bearing cycling, finishing with 5 min of low-intensity cool-down stretching and breathing exercises.
Main part of the training was interval. Each exercise session consisted of 3 to 4 high intensity intervals with intensity exceeding 80% of HRmax, often reaching anaerobic threshold. High intensity intervals lasted approximately 4-minutes and were interspersed by recovery periods at 65-80% of HRmax.
HR during sessions was monitored with a Suunto Fitness Solution® device (Suunto, Vantaa, Finland). To ensure that assigned exercise intensities were obtained, the average per cent of the maximum heart rate during the entire training session was obtained from the device Blood samples for biochemical analyses were taken from a basilic vein, after overnight 12-hour fasting. In the serum samples, parameters were measured using commercially available enzyme-linked immunoassays.
Both before and after the whole training programme, the following measurements were made: body weight and height, BMI, waist and hip circumference, WHR, body composition (DXA), total-body skeletal muscle mass index, graded exercise test, isokinetic muscle strength of knee flexors and extensors, exercise and resting blood pressure, and the heart rate. Vascular endothelial function indices (eNOS, VEGF, TBARS and TAS) as well as TCH, LDL-C, HDL-C, TG, oxLDL and CRP of venous blood were determined.
A sample size was determined according to changes in VO2 peak. A total of 6 subjects in OW group and 7 subjects in NW group was calculated to yield at least 80% power of detecting an intervention effect as statistically significant at the 0.05 α level.
Detailed description
Anthropometric measurements were conducted with the subjects wearing light clothing and no shoes. Weight was measured to the nearest 0.1 kg and height to the nearest 0.5 cm. BMI was calculated as weight divided by height squared (kg/m2 ). Obesity was defined as BMI ≥ 30 kg/m2. Waist circumference (cm) was measured at the level of the iliac crest at the end of normal expiration. Hip circumference was measured at the maximum protuberance of the buttocks. Waist and hip circumferences were measured to the nearest 0.5 cm. Waist-to-hip ratio (WHR) was calculated as waist circumference divided by hip circumference. Index of central obesity (ICO) was calculated as waist circumference (cm) divided by height (cm) (Parikh, et al., 2012).
Body composition analysis was assessed using DXA (GE Healthcare Lunar Prodigy Advance; GE Medical Systems, Milan, Italy). The subjects were instructed not to make any intense physical effort in the 24h prior to the examination. The subjects were given complete instructions on the examination procedure. They wore cotton T-shirt, shorts, and socks and lay on the DXA table supine and motionlessly during the testing procedure. They were instructed to remove all metal, rubber, and plastic objects that might affect the X-ray beam. The same well-trained laboratory technician positioned the subjects, performed the scans, and executed the analysis according to the operator's manual, using the standard analysis protocol. Total body fat mass and lean body mass were determined using standard scan mode (in case of moderately obese subjects) or thick scan mode (in case of extremely obese subjects); the absorbed dose of radiation was 0.4 μGy and 0.8 μGy, respectively.
To determine the subjects' physical capacity, a Graded Exercise Test (GXT) was performed on an electronically braked cycle ergometer (Kettler ® DX1 Pro, Kettler, Ense, Germany). GXT began at a work rate of 25 W (60 rev/min). The work rate was incremented by 25 W every 2 min until the subject could no longer maintain the required pedal cadence. Each test lasted 4-14.5 min, depending on age and aerobic fitness status. The exercise tests were conducted between 8: 00 and 12: 00 a.m. in an air-conditioned laboratory, 2 h after consuming a light breakfast. Expired gases, minute ventilations (Ve), and heart rate (HR) during GXT were monitored continuously with an automated system (Oxycon Mobile ® ; Viasys Healthcare, Hoechberg, Germany). Oxygen intake (VO 2 ) and carbon dioxide output (VCO 2 ) was measured breath-by-breath and averaged over 15-second periods. Before each trial, the system was calibrated according to the manufacturer's instructions. Peak VO2 was defined as the highest 15-second averaged VO 2 obtained during the final exercise load on the test. HR peak (bpm) was measured as the highest 15-second average value in the test. To determine ventilatory threshold (VT), the V-slope method was administered using computerized regression analysis on the slopes of the CO 2 output versus O2 uptake plot, which detects the beginning of the excess CO 2 output generated from the buffering of H +. The method involves analyzing the behavior of VCO 2 as a function of VO 2 during GXT with a consequent increase in VCO 2 . This results in a transition in the relationship between VCO 2 and VO 2 . The software supplied by Viasys Healthcare was used, supported with a visual inspection on the part of an experienced researcher. As a secondary method, the ventilatory equivalent method (VEQ method) was employed and the point at which the equivalent for oxygen (VE/VO 2 ) increased without a concomitant rise in the equivalent for carbon dioxide (VE/VCO 2 ) was detected. The VT was expressed as a heart rate (HR VT ).
Exercise blood pressure was measured during a GXT using a digital electronic tensiometer (model 705IT TM, Omron Corporation, Kyoto, Japan). The measurement was taken during maximal work rate. Exercise HR was measured as the highest 15-second average value in the GXT. Resting blood pressure was measured fasting in the morning hours, in a sitting position with the legs uncrossed and the back and arm supported. Resting HR was measured under the same conditions, using auscultation of the heart by stethoscope. Regular or large adult cuffs were used, depending on the patient's arm circumference.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was designed as a prospective trial where two similar groups of women only differing in body mass participate in the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Women with Obesity | Experimental | Behavioral: Indoor Cycling Interval Exercise Training23 healthy, obese (BMI ≥ 30 kg/m2; waist circumference > 80) women, aged 34-62, screened at the outpatient clinic of the Department of Internal Medicine, Metabolic Disorders, and Hypertension, University of Medical Sciences, Poznań, Poland were enrolled based on the inclusion criteria and the willingness to participate in the research. |
| Normal-weight Women | Active comparator | Behavioral: Indoor Cycling Interval Exercise Training8 healthy, normal-weight (≤ 24.9 and ≥ 18.5 kg/m2) women, aged 34-62 were enrolled to intervention from the announcement. Random selection for groups was not applicable due to the planned body mass difference in the studied groups. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Initial inclusion criteria for both study groups were as follows: age: 30 to 65 years and stable body weight in the month prior to the trial (permissible deviation ± 1 kg).
- For Women with Obesity Group: BMI ≥ 30 kg/m2; waist circumference > 80 cm. For Normal-weight Womeng Group: BMI ≤ 24.9 and ≥ 18.5 kg/m2
Key exclusion criteria (14 listed)
- secondary form of obesity and/or secondary form of hypertension;
- diabetes mellitus;
- history of coronary artery disease;
- stroke;
- congestive heart failure;
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 |
|---|---|---|
| Indoor Cycling Interval Exercise TrainingAlso: Spinning Interval Physical TrainingThe 3-month intervention consisted of a physical exercise program involving three indoor cycling sessions per week, with a total of 36 training sessions. Subjects exercised on cycle ergometers Schwinn® Evolution® (Schwinn Bicycle Company, Boulder, Colorado, USA). Each session lasted approximately 55 minutes. Training sessions consisted of a 5-min low-intensity warm-up (cycling at 50-65% of maximum heart rate (HRmax)), 40 min of main training at an intensity of 65-95% of HRmax, 5 min of non-weight-bearing cycling, finishing with 5 min of low-intensity cool-down stretching and breathing exercises. Main part of the training was interval. Each exercise session consisted of 3 to 4 high intensity intervals with intensity exceeding 80% of HRmax, often reaching anaerobic threshold. High intensity intervals lasted approximately 4-minutes and were interspersed by recovery periods at 65-80% of HRmax. | Behavioural | Normal-weight Women, Women with Obesity |
Primary outcome
Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]
Time frame: At baseline
Dimension Flex Reagent Cartridge
Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]
Time frame: After three months of physical training
Dimension Flex Reagent Cartridge
Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]
Time frame: At baseline
ELISA
Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]
Time frame: After three months of physical training
ELISA
Blood total antioxidant capacity (TAC) [mmolCRE/l]
Time frame: At baseline
ELISA
Blood total antioxidant capacity (TAC) [mmolCRE/l]
Time frame: After three months of physical training
ELISA
Thiobarbituric acid reactive substances (TBARS) [μmol/l]
Time frame: At baseline
ELISA
Thiobarbituric acid reactive substances (TBARS) [μmol/l]
Time frame: After three months of physical training
ELISA
Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]
Time frame: At baseline
ELISA
Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]
Time frame: After three months of physical training
ELISA
Vascular endothelial growth factor (VEGF) [pg/ml]
Time frame: At baseline
ELISA
Vascular endothelial growth factor (VEGF) [pg/ml]
Time frame: After three months of physical training
ELISA
C-reactive protein concentration (CRP) [mg/l]
Time frame: At baseline
ELISA
C-reactive protein concentration (CRP) [mg/l]
Time frame: After three months of physical training
ELISA
12 secondary outcomes
Body mass [kg]
Time frame: At baseline
Body mass [kg]
Time frame: After three months of physical training
Body height, waist circumference, hip circumference [cm]
Time frame: At baseline
Body height, waist circumference, hip circumference [cm]
Time frame: After three months of physical training
Body composition
Time frame: At baseline
Body composition
Time frame: After three months of physical training
Peak oxygen uptake (VO2 peak) [ml•min-1•kg-1]
Time frame: At baseline
Peak oxygen uptake (VO2 peak) [ml•min-1•kg-1]
Time frame: After three months of physical training
Resting heart rate [bpm], Peak heart rate [bpm], Ventilatory threshold heart rate [bpm],
Time frame: At baseline
Resting heart rate [bpm], Peak heart rate [bpm], Ventilatory threshold heart rate [bpm],
Time frame: After three months of physical training
Resting SBP [mmHg], Resting DBP [mmHg], Exercise SBP [mmHg], Exercise DBP [mmHg]
Time frame: At baseline
Resting SBP [mmHg], Resting DBP [mmHg], Exercise SBP [mmHg], Exercise DBP [mmHg]
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 2 Jul 2020.
- Background: PubMed 20585293Bianco A, Bellafiore M, Battaglia G, Paoli A, Caramazza G, Farina F, Palma A. The effects of indoor cycling training in sedentary overweight women. J Sports Med Phys Fitness. 2010 Jun;50(2):159-65.
- Background: PubMed 31443139Chavarrias M, Carlos-Vivas J, Collado-Mateo D, Perez-Gomez J. Health Benefits of Indoor Cycling: A Systematic Review. Medicina (Kaunas). 2019 Aug 8;55(8):452. doi: 10.3390/medicina55080452.
- Background: PubMed 24730354Damaso AR, da Silveira Campos RM, Caranti DA, de Piano A, Fisberg M, Foschini D, de Lima Sanches P, Tock L, Lederman HM, Tufik S, de Mello MT. Aerobic plus resistance training was more effective in improving the visceral adiposity, metabolic profile and inflammatory markers than aerobic training in obese adolescents. J Sports Sci. 2014;32(15):1435-45. doi: 10.1080/02640414.2014.900692. Epub 2014 Apr 14.
- Background: PubMed 23205751Ho SS, Radavelli-Bagatini S, Dhaliwal SS, Hills AP, Pal S. Resistance, aerobic, and combination training on vascular function in overweight and obese adults. J Clin Hypertens (Greenwich). 2012 Dec;14(12):848-54. doi: 10.1111/j.1751-7176.2012.00700.x. Epub 2012 Aug 20.
- Background: PubMed 30689632Su L, Fu J, Sun S, Zhao G, Cheng W, Dou C, Quan M. Effects of HIIT and MICT on cardiovascular risk factors in adults with overweight and/or obesity: A meta-analysis. PLoS One. 2019 Jan 28;14(1):e0210644. doi: 10.1371/journal.pone.0210644. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indoor Cycling Interval Exercise Training in people with Obesity and Dyslipidemias, run by Poznan University of Physical Education 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 2 inclusion and 14 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 2 Jul 2020. 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?
Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l] (time frame: At baseline). The study lists 14 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 NCT04456192, which also lists 5 linked publications.
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 2 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.