Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04456192
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2020-06-24
Brief Title:
Effects of an Indoor Cycling Program on Cardio-Metabolic Factors in Women With Obesity and Normal Body Weight
Sponsor:
Poznan University of Physical Education
Organization:
Poznan University of Physical Education
Study Overview
Official Title:
Effects of an Indoor Cycling Program on Cardio-Metabolic Factors in Women With Obesity and Normal Body Weight
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 participants 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 kgm2 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 249 and 185 kgm2
Informed consent was obtained from all participants and the study was approved by the Ethics Committee of Poznan University of Medical Sciences case no 107712 supplement no 75313 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 005 α level
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 participants 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 kgm2 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 249 and 185 kgm2
Informed consent was obtained from all participants and the study was approved by the Ethics Committee of Poznan University of Medical Sciences case no 107712 supplement no 75313 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 005 α level
Detailed Description:
Anthropometric measurements were conducted with the subjects wearing light clothing and no shoes Weight was measured to the nearest 01 kg and height to the nearest 05 cm BMI was calculated as weight divided by height squared kgm2 Obesity was defined as BMI 30 kgm2 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 05 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 operators 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 04 μGy and 08 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 revmin 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 4-145 min depending on age and aerobic fitness status The exercise tests were conducted between 8 00 and 12 00 am 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 manufacturers 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 VEVO 2 increased without a concomitant rise in the equivalent for carbon dioxide VEVCO 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 patients arm circumference
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 operators 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 04 μGy and 08 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 revmin 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 4-145 min depending on age and aerobic fitness status The exercise tests were conducted between 8 00 and 12 00 am 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 manufacturers 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 VEVO 2 increased without a concomitant rise in the equivalent for carbon dioxide VEVCO 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 patients arm circumference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None