<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04456192</url>
  </required_header>
  <id_info>
    <org_study_id>PoznanUPhyEd no. 2</org_study_id>
    <nct_id>NCT04456192</nct_id>
  </id_info>
  <brief_title>Effects of an Indoor Cycling Program on Cardio-Metabolic Factors in Women With Obesity and Normal Body Weight</brief_title>
  <official_title>Effects of an Indoor Cycling Program on Cardio-Metabolic Factors in Women With Obesity and Normal Body Weight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Physical Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Poznan University of Physical Education</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the research is to (1) evaluate the potential clinical effectiveness and&#xD;
      biological mechanisms of indoor cycling in the treatment of obesity and (2)&#xD;
      provide-up-to-date evidence on the impact of indoor cycling in reducing cardiovascular&#xD;
      disease (CVD) risk factors, namely, hypertension, dyslipidemia, type 2 diabetes, endothelial&#xD;
      dysfunction. We hypothesize that IC training, can be a good stimulus to mitigate&#xD;
      cardiovascular risk factors in women with obesity and to improve values of the examined&#xD;
      indicators towards that occurring in women with normal body weight.&#xD;
&#xD;
      The study was designed as a prospective exercise intervention trial. The study involved women&#xD;
      with obesity (OW) and women with normal body weight (NW). Both study groups underwent the&#xD;
      same 3-month physical training program. Outside the implemented program, all participants&#xD;
      were instructed to maintain their normal physical activity, diet and not to use any dietary&#xD;
      supplements. Dietary intake was assessed using interviews conducted at baseline and after&#xD;
      completion of the trial. The amount of nutrients in participant's daily diet was processed&#xD;
      and evaluated using a dietetics computer program. The intake of nutrients, total caloric&#xD;
      intake during the study were constant in both groups. Anthropometric parameters, blood&#xD;
      pressure and physical capacity were measured and blood samples were taken at baseline and&#xD;
      after completion of the physical training program.&#xD;
&#xD;
      The study involved 31 obese or normal weight women aged 34-62. A total of 23 women with&#xD;
      obesity (body mass index (BMI) ≥ 30 kg/m2; waist circumference &gt; 80 cm) registered and&#xD;
      screened from among 163 women at the outpatient clinic of the Department of Internal&#xD;
      Medicine, Metabolic Disorders, and Hypertension, University of Medical Sciences, Poznań,&#xD;
      Poland were enrolled to OW group. The NW group consisted of 8 healthy women from the&#xD;
      announcement (BMI ≤ 24.9 and ≥ 18.5 kg/m2).&#xD;
&#xD;
      Informed consent was obtained from all participants, and the study was approved by the Ethics&#xD;
      Committee of Poznan University of Medical Sciences (case no. 1077/12; supplement no. 753/13).&#xD;
      The study conformed to all ethical issues included in the Helsinki Declaration.&#xD;
&#xD;
      The 3-month intervention consisted of a physical exercise program involving three indoor&#xD;
      cycling sessions per week, with a total of 36 training sessions. Subjects exercised on cycle&#xD;
      ergometers Schwinn® Evolution® (Schwinn Bicycle Company, Boulder, Colorado, USA). Each&#xD;
      session lasted approximately 55 minutes. Training sessions consisted of a 5-min low-intensity&#xD;
      warm-up (cycling at 50-65% of maximum heart rate (HRmax)), 40 min of main training at an&#xD;
      intensity of 65-95% of HRmax, 5 min of non-weight-bearing cycling, finishing with 5 min of&#xD;
      low-intensity cool-down stretching and breathing exercises.&#xD;
&#xD;
      Main part of the training was interval. Each exercise session consisted of 3 to 4 high&#xD;
      intensity intervals with intensity exceeding 80% of HRmax, often reaching anaerobic&#xD;
      threshold. High intensity intervals lasted approximately 4-minutes and were interspersed by&#xD;
      recovery periods at 65-80% of HRmax.&#xD;
&#xD;
      HR during sessions was monitored with a Suunto Fitness Solution® device (Suunto, Vantaa,&#xD;
      Finland). To ensure that assigned exercise intensities were obtained, the average per cent of&#xD;
      the maximum heart rate during the entire training session was obtained from the device Blood&#xD;
      samples for biochemical analyses were taken from a basilic vein, after overnight 12-hour&#xD;
      fasting. In the serum samples, parameters were measured using commercially available&#xD;
      enzyme-linked immunoassays.&#xD;
&#xD;
      Both before and after the whole training programme, the following measurements were made:&#xD;
      body weight and height, BMI, waist and hip circumference, WHR, body composition (DXA),&#xD;
      total-body skeletal muscle mass index, graded exercise test, isokinetic muscle strength of&#xD;
      knee flexors and extensors, exercise and resting blood pressure, and the heart rate. Vascular&#xD;
      endothelial function indices (eNOS, VEGF, TBARS and TAS) as well as TCH, LDL-C, HDL-C, TG,&#xD;
      oxLDL and CRP of venous blood were determined.&#xD;
&#xD;
      A sample size was determined according to changes in VO2 peak. A total of 6 subjects in OW&#xD;
      group and 7 subjects in NW group was calculated to yield at least 80% power of detecting an&#xD;
      intervention effect as statistically significant at the 0.05 α level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anthropometric measurements were conducted with the subjects wearing light clothing and no&#xD;
      shoes. Weight was measured to the nearest 0.1 kg and height to the nearest 0.5 cm. BMI was&#xD;
      calculated as weight divided by height squared (kg/m2 ). Obesity was defined as BMI ≥ 30&#xD;
      kg/m2. Waist circumference (cm) was measured at the level of the iliac crest at the end of&#xD;
      normal expiration. Hip circumference was measured at the maximum protuberance of the&#xD;
      buttocks. Waist and hip circumferences were measured to the nearest 0.5 cm. Waist-to-hip&#xD;
      ratio (WHR) was calculated as waist circumference divided by hip circumference. Index of&#xD;
      central obesity (ICO) was calculated as waist circumference (cm) divided by height (cm)&#xD;
      (Parikh, et al., 2012).&#xD;
&#xD;
      Body composition analysis was assessed using DXA (GE Healthcare Lunar Prodigy Advance; GE&#xD;
      Medical Systems, Milan, Italy). The subjects were instructed not to make any intense physical&#xD;
      effort in the 24h prior to the examination. The subjects were given complete instructions on&#xD;
      the examination procedure. They wore cotton T-shirt, shorts, and socks and lay on the DXA&#xD;
      table supine and motionlessly during the testing procedure. They were instructed to remove&#xD;
      all metal, rubber, and plastic objects that might affect the X-ray beam. The same&#xD;
      well-trained laboratory technician positioned the subjects, performed the scans, and executed&#xD;
      the analysis according to the operator's manual, using the standard analysis protocol. Total&#xD;
      body fat mass and lean body mass were determined using standard scan mode (in case of&#xD;
      moderately obese subjects) or thick scan mode (in case of extremely obese subjects); the&#xD;
      absorbed dose of radiation was 0.4 μGy and 0.8 μGy, respectively.&#xD;
&#xD;
      To determine the subjects' physical capacity, a Graded Exercise Test (GXT) was performed on&#xD;
      an electronically braked cycle ergometer (Kettler ® DX1 Pro, Kettler, Ense, Germany). GXT&#xD;
      began at a work rate of 25 W (60 rev/min). The work rate was incremented by 25 W every 2 min&#xD;
      until the subject could no longer maintain the required pedal cadence. Each test lasted&#xD;
      4-14.5 min, depending on age and aerobic fitness status. The exercise tests were conducted&#xD;
      between 8: 00 and 12: 00 a.m. in an air-conditioned laboratory, 2 h after consuming a light&#xD;
      breakfast. Expired gases, minute ventilations (Ve), and heart rate (HR) during GXT were&#xD;
      monitored continuously with an automated system (Oxycon Mobile ® ; Viasys Healthcare,&#xD;
      Hoechberg, Germany). Oxygen intake (VO 2 ) and carbon dioxide output (VCO 2 ) was measured&#xD;
      breath-by-breath and averaged over 15-second periods. Before each trial, the system was&#xD;
      calibrated according to the manufacturer's instructions. Peak VO2 was defined as the highest&#xD;
      15-second averaged VO 2 obtained during the final exercise load on the test. HR peak (bpm)&#xD;
      was measured as the highest 15-second average value in the test. To determine ventilatory&#xD;
      threshold (VT), the V-slope method was administered using computerized regression analysis on&#xD;
      the slopes of the CO 2 output versus O2 uptake plot, which detects the beginning of the&#xD;
      excess CO 2 output generated from the buffering of H +. The method involves analyzing the&#xD;
      behavior of VCO 2 as a function of VO 2 during GXT with a consequent increase in VCO 2 . This&#xD;
      results in a transition in the relationship between VCO 2 and VO 2 . The software supplied by&#xD;
      Viasys Healthcare was used, supported with a visual inspection on the part of an experienced&#xD;
      researcher. As a secondary method, the ventilatory equivalent method (VEQ method) was&#xD;
      employed and the point at which the equivalent for oxygen (VE/VO 2 ) increased without a&#xD;
      concomitant rise in the equivalent for carbon dioxide (VE/VCO 2 ) was detected. The VT was&#xD;
      expressed as a heart rate (HR VT ).&#xD;
&#xD;
      Exercise blood pressure was measured during a GXT using a digital electronic tensiometer&#xD;
      (model 705IT TM, Omron Corporation, Kyoto, Japan). The measurement was taken during maximal&#xD;
      work rate. Exercise HR was measured as the highest 15-second average value in the GXT.&#xD;
      Resting blood pressure was measured fasting in the morning hours, in a sitting position with&#xD;
      the legs uncrossed and the back and arm supported. Resting HR was measured under the same&#xD;
      conditions, using auscultation of the heart by stethoscope. Regular or large adult cuffs were&#xD;
      used, depending on the patient's arm circumference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">June 15, 2016</completion_date>
  <primary_completion_date type="Actual">June 15, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]</measure>
    <time_frame>At baseline</time_frame>
    <description>Dimension Flex Reagent Cartridge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>Dimension Flex Reagent Cartridge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]</measure>
    <time_frame>At baseline</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood total antioxidant capacity (TAC) [mmolCRE/l]</measure>
    <time_frame>At baseline</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood total antioxidant capacity (TAC) [mmolCRE/l]</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thiobarbituric acid reactive substances (TBARS) [μmol/l]</measure>
    <time_frame>At baseline</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thiobarbituric acid reactive substances (TBARS) [μmol/l]</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]</measure>
    <time_frame>At baseline</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vascular endothelial growth factor (VEGF) [pg/ml]</measure>
    <time_frame>At baseline</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vascular endothelial growth factor (VEGF) [pg/ml]</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reactive protein concentration (CRP) [mg/l]</measure>
    <time_frame>At baseline</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reactive protein concentration (CRP) [mg/l]</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass [kg]</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass [kg]</measure>
    <time_frame>After three months of physical training</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body height, waist circumference, hip circumference [cm]</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body height, waist circumference, hip circumference [cm]</measure>
    <time_frame>After three months of physical training</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>At baseline</time_frame>
    <description>Dual-energy X-ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>Dual-energy X-ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak oxygen uptake (VO2 peak) [ml•min-1•kg-1]</measure>
    <time_frame>At baseline</time_frame>
    <description>Graded Exercise Test (GXT) with an automated system Oxycon Mobile ®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak oxygen uptake (VO2 peak) [ml•min-1•kg-1]</measure>
    <time_frame>After three months of physical training</time_frame>
    <description>Graded Exercise Test (GXT) with an automated system Oxycon Mobile ®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting heart rate [bpm], Peak heart rate [bpm], Ventilatory threshold heart rate [bpm],</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting heart rate [bpm], Peak heart rate [bpm], Ventilatory threshold heart rate [bpm],</measure>
    <time_frame>After three months of physical training</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting SBP [mmHg], Resting DBP [mmHg], Exercise SBP [mmHg], Exercise DBP [mmHg]</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting SBP [mmHg], Resting DBP [mmHg], Exercise SBP [mmHg], Exercise DBP [mmHg]</measure>
    <time_frame>After three months of physical training</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Obesity</condition>
  <condition>Dyslipidemias</condition>
  <condition>Hypertension</condition>
  <condition>Type 2 Diabetes</condition>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>Women with Obesity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>23 healthy, obese (BMI ≥ 30 kg/m2; waist circumference &gt; 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal-weight Women</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>8 healthy, normal-weight (≤ 24.9 and ≥ 18.5 kg/m2) women, aged 34-62 were enrolled to intervention from the announcement.&#xD;
Random selection for groups was not applicable due to the planned body mass difference in the studied groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Indoor Cycling Interval Exercise Training</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Normal-weight Women</arm_group_label>
    <arm_group_label>Women with Obesity</arm_group_label>
    <other_name>Spinning Interval Physical Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Initial inclusion criteria for both study groups were as follows: age: 30 to 65 years and&#xD;
        stable body weight in the month prior to the trial (permissible deviation ± 1 kg).&#xD;
&#xD;
        For Women with Obesity Group: BMI ≥ 30 kg/m2; waist circumference &gt; 80 cm. For&#xD;
        Normal-weight Womeng Group: BMI ≤ 24.9 and ≥ 18.5 kg/m2&#xD;
&#xD;
        Exclusion Criteria for both study groups were as follows:&#xD;
&#xD;
          -  secondary form of obesity and/or secondary form of hypertension;&#xD;
&#xD;
          -  diabetes mellitus;&#xD;
&#xD;
          -  history of coronary artery disease;&#xD;
&#xD;
          -  stroke;&#xD;
&#xD;
          -  congestive heart failure;&#xD;
&#xD;
          -  clinically significant arrhythmias or conduction disorders;&#xD;
&#xD;
          -  malignancy;&#xD;
&#xD;
          -  poorly controlled hypertension (SBP &gt; 140 mmHg and/or DBP &gt; 90 mmHg), and/or&#xD;
             modifications to antihypertensive treatment;&#xD;
&#xD;
          -  lipid disorders requiring the implementation of drug treatment;&#xD;
&#xD;
          -  clinically significant abnormalities in liver, kidney or thyroid gland function;&#xD;
&#xD;
          -  clinically significant acute or chronic inflammatory process within the respiratory,&#xD;
             digestive or genitourinary tracts, or the oral cavity, pharynx or paranasal sinuses;&#xD;
             or, presence of connective tissue disease or arthritis;&#xD;
&#xD;
          -  history of infection within the month prior to the study;&#xD;
&#xD;
          -  nicotine, alcohol or drug abuse;&#xD;
&#xD;
          -  and / or any other condition which, according to the researchers, would cause that&#xD;
             participation would be detrimental to the participant or would prevent, limit or&#xD;
             interfere with the results of the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Poznan University of Physical Education</name>
      <address>
        <city>Poznań</city>
        <state>Greater Poland</state>
        <zip>61-871</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20585293</PMID>
  </reference>
  <reference>
    <citation>Chavarrias 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.</citation>
    <PMID>31443139</PMID>
  </reference>
  <reference>
    <citation>Damaso 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.</citation>
    <PMID>24730354</PMID>
  </reference>
  <reference>
    <citation>Ho 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.</citation>
    <PMID>23205751</PMID>
  </reference>
  <reference>
    <citation>Su 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.</citation>
    <PMID>30689632</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Physical Education</investigator_affiliation>
    <investigator_full_name>Marzena Ratajczak</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>indoor cycling</keyword>
  <keyword>interval physical training</keyword>
  <keyword>cardio-metabolic factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456192
org study id: PoznanUPhyEd no. 2
nct id: NCT04456192
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Basic Science
masking: None (Open Label)
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
description: Dimension Flex Reagent Cartridge
measure: 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
description: Dimension Flex Reagent Cartridge
measure: Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]
time frame: At baseline
description: ELISA
measure: Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]
time frame: After three months of physical training
description: ELISA
measure: Blood total antioxidant capacity (TAC) [mmolCRE/l]
time frame: At baseline
description: ELISA
measure: Blood total antioxidant capacity (TAC) [mmolCRE/l]
time frame: After three months of physical training
description: ELISA
measure: Thiobarbituric acid reactive substances (TBARS) [μmol/l]
time frame: At baseline
description: ELISA
measure: Thiobarbituric acid reactive substances (TBARS) [μmol/l]
time frame: After three months of physical training
description: ELISA
measure: Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]
time frame: At baseline
description: ELISA
measure: Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]
time frame: After three months of physical training
description: ELISA
measure: Vascular endothelial growth factor (VEGF) [pg/ml]
time frame: At baseline
description: ELISA
measure: Vascular endothelial growth factor (VEGF) [pg/ml]
time frame: After three months of physical training
description: ELISA
measure: C-reactive protein concentration (CRP) [mg/l]
time frame: At baseline
description: ELISA
measure: C-reactive protein concentration (CRP) [mg/l]
time frame: After three months of physical training
description: ELISA
measure: Body mass [kg]
time frame: At baseline
measure: Body mass [kg]
time frame: After three months of physical training
measure: Body height, waist circumference, hip circumference [cm]
time frame: At baseline
measure: Body height, waist circumference, hip circumference [cm]
time frame: After three months of physical training
measure: Body composition
time frame: At baseline
description: Dual-energy X-ray Absorptiometry
measure: Body composition
time frame: After three months of physical training
description: Dual-energy X-ray Absorptiometry
measure: Peak oxygen uptake (VO2 peak) [ml•min-1•kg-1]
time frame: At baseline
description: Graded Exercise Test (GXT) with an automated system Oxycon Mobile ®
measure: Peak oxygen uptake (VO2 peak) [ml•min-1•kg-1]
time frame: After three months of physical training
description: Graded Exercise Test (GXT) with an automated system Oxycon Mobile ®
measure: Resting heart rate [bpm], Peak heart rate [bpm], Ventilatory threshold heart rate [bpm],
time frame: At baseline
measure: Resting heart rate [bpm], Peak heart rate [bpm], Ventilatory threshold heart rate [bpm],
time frame: After three months of physical training
measure: Resting SBP [mmHg], Resting DBP [mmHg], Exercise SBP [mmHg], Exercise DBP [mmHg]
time frame: At baseline
measure: Resting SBP [mmHg], Resting DBP [mmHg], Exercise SBP [mmHg], Exercise DBP [mmHg]
time frame: After three months of physical training
arm group label: Women with Obesity
arm group type: Experimental
description: 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.
arm group label: Normal-weight Women
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Indoor Cycling Interval Exercise Training
description: 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.
arm group label: Normal-weight Women
arm group label: Women with Obesity
other name: Spinning Interval Physical Training
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
citation: 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.
PMID: 20585293
citation: Chavarrias 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.
PMID: 31443139
citation: Damaso 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.
PMID: 24730354
citation: Ho 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.
PMID: 23205751
citation: Su 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.
PMID: 30689632
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Physical Education
investigator full name: Marzena Ratajczak
investigator title: assistant professor
mesh term: Obesity
mesh term: Dyslipidemias
mesh term: Body Weight
sharing ipd: No