Effects of an Indoor Cycling Program on Cardio-Metabolic Factors in Women With Obesity and Normal Body Weight

NCT04456192 | Completed

• 1 other identifier: PoznanUPhyEd no. 2
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity; Dyslipidemias; Hypertension; Type 2 Diabetes; Endothelial Dysfunction

Keywords

obesity; indoor cycling; interval physical training; cardio-metabolic factors

Outcome Measures

Primary Outcomes (14)

• Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]

  Dimension Flex Reagent Cartridge

  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

  After three months of physical training

• Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]

  ELISA

  At baseline

• Human anti-oxidized low density lipoprotein antibody (OLAb) [U/L]

  ELISA

  After three months of physical training

• Blood total antioxidant capacity (TAC) [mmolCRE/l]

  ELISA

  At baseline

• Blood total antioxidant capacity (TAC) [mmolCRE/l]

  ELISA

  After three months of physical training

• Thiobarbituric acid reactive substances (TBARS) [μmol/l]

  ELISA

  At baseline

• Thiobarbituric acid reactive substances (TBARS) [μmol/l]

  ELISA

  After three months of physical training

• Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]

  ELISA

  At baseline

• Activity of endothelial nitric oxide synthase (eNOS) [ng/ml]

  ELISA

  After three months of physical training

• Vascular endothelial growth factor (VEGF) [pg/ml]

  ELISA

  At baseline

• Vascular endothelial growth factor (VEGF) [pg/ml]

  ELISA

  After three months of physical training

• C-reactive protein concentration (CRP) [mg/l]

  ELISA

  At baseline

• C-reactive protein concentration (CRP) [mg/l]

  ELISA

  After three months of physical training

Secondary Outcomes (12)

• Body mass [kg]

  At baseline

• Body mass [kg]

  After three months of physical training

• Body height, waist circumference, hip circumference [cm]

  At baseline

• Body height, waist circumference, hip circumference [cm]

  After three months of physical training

• Body composition

  At baseline

Study Arms (2)

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.

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.

Behavioral: Indoor Cycling Interval Exercise Training

Interventions

Indoor Cycling Interval Exercise Training BEHAVIORAL

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.

Also known as: Spinning Interval Physical Training

Normal-weight Women; Women with Obesity

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Poznan University of Physical Education: lead
• Poznan University of Medical Sciences: collaborator

Study Sites (1)

Poznan University of Physical Education

Poznan, Greater Poland Voivodeship, 61-871, Poland

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Obesity; Dyslipidemias; Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: The study was designed as a prospective trial where two similar groups of women only differing in body mass participate in the same intervention.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 2, 2020
• Study Start: January 1, 2013
• Primary Completion: June 15, 2016
• Study Completion: June 15, 2016
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)