Obesity, Overweight
Conditions
Brief summary
This randomized controlled trial investigates the effects of two types of stair-climbing exercise snacks versus moderate-intensity continuous training on vascular health, body composition, and blood lipids in overweight or obese adults. Participants will be assigned to one of four groups for 6-8 weeks. The control group receives no exercise intervention. Primary outcomes include endothelial function (ultrasound), body composition (InBody), and lipid profile (blood test).
Detailed description
This is a parallel group randomized controlled trial, with the study subjects being overweight or obese adults (with a body mass index of ≥ 24 kg/m²). Participants will be recruited from universities and randomly assigned to one of the following four groups: Short-term stair climbing exercise group Participants climbed the stairs 4 to 5 times a day, each time ascending 5 floors (approximately 1 minute each time). There was at least a 1-hour interval between each exercise session, and the exercises were carried out during daily activities. They exercised 3 to 5 times a week for 6 to 8 weeks. Long-term stair climbing nutrition supplementation group The participants also conducted 4 to 5 stair climbing training sessions every day. Each training session consisted of 3 sets of climbing 5 floors (the total climbing height for each training session was 15 floors), with a rest period of no more than 1 minute between each set. The interval between two training sessions was no less than 1 hour. They exercised 3 to 5 times a week for 6 to 8 weeks. Moderate-intensity continuous training group (MICT) Participants engaged in 30-minute moderate-intensity running (including warm-up and cool-down activities) each time, 3 to 5 times a week, for 6 to 8 weeks. Control group Participants maintained their daily activities and did not receive any exercise intervention measures. Result measurement indicators: Vascular health: Assessing endothelial function through ultrasound measurement of flow-mediated vascular dilation (FMD). Body composition: Measured using the InBody body bioelectrical impedance analyzer (including muscle mass, fat mass and body fat percentage). Blood lipid test: Collect fasting blood samples and measure low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (TG), and total cholesterol (TC). Measurement time points: Measurements were conducted at the baseline (at the beginning of the study), 3-4 weeks (during the intervention period), and 8 weeks (after the intervention ended). This research protocol has been approved by the Institutional Review Board of Shandong Second Medical University. All participants are required to sign a written informed consent form.
Interventions
BEHAVIORALShort-term stair climbing exercise snack group
Adopt a fragmented approach, climbing stairs 4-5 times a day, each time climbing 5 floors (approximately 1 minute per session), with at least 1 hour of interval between each session, and spread throughout the daily activity periods. Exercise 3-5 days per week for a total of 6-8 weeks.
BEHAVIORALLong-duration stair climbing exercise snack group
On the basis of climbing stairs 4 to 5 times a day, increase the single exercise volume: complete 2 or 3 sets of climbing 5 floors of stairs each time (that is, the total number of floors climbed each time is 10 or 15), with no more than 1 minute of rest between sets. The intervals between each exercise should be at least 1 hour. Exercise 3 to 5 days a week, for a total of 6 to 8 weeks of intervention.
BEHAVIORALModerate-intensity continuous exercise（MICT）
Exercise 3 to 5 days per week for a total of 6 to 8 weeks. Perform 30 minutes of moderate-intensity running training every day.
Sponsors
Weifang Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the particularity of the exercise intervention, it is not possible to blind the participants and the exercise instructors. However, it is feasible to blind the outcome assessors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-35 years old (male, female); 2. Clear consciousness, stable vital signs; 3. Able to understand and follow simple instructions; 4. No regular exercise for at least 3 months; 5. BMI ≥ 24 kg/m2.
Exclusion criteria
1. There are other serious diseases, such as tumors; 2. There are other neurological diseases; 3. There are serious diseases that simultaneously affect the heart, liver, kidneys, endocrine system or hematopoietic system; 4. There is a history of alcohol or drug abuse; 5. Participated in other clinical trials that might affect the results of this study; 6. There are other neurological or musculoskeletal diseases, with pain worsening with exercise; 7. It is forbidden to engage in physical training. 8. Within the past 3 months, there have been acute cardiovascular events such as acute myocardial infarction,unstable angina pectoris, severe arrhythmia, acute heart failure, etc.； 9. Uncontrolled hypertension； 10. Severe pulmonary diseases, such as uncontrolled asthma, acute exacerbation of chronic obstructive pulmonary disease, interstitial lung disease with significant exercise limitation； 11. Severe joint and bone diseases, acute soft tissue injuries, fractures that have not healed, etc., making it impossible to complete the prescribed exercise load； 12. Presence of bleeding tendencies, coagulation dysfunction, or within the past 1 month, there has been major bleeding or a history of surgery； 13. The investigator judges that there are any other situations that may affect the safety of the subjects or the results of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated dilation (FMD, relative percentage) | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Flow-mediated dilation expressed as a percentage of the baseline brachial artery diameter.Unit of Measure: % |
| Body fat mass | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Body fat mass measured by bioelectrical impedance analysis (InBody device). Unit of Measure: kg |
| Time to peak dilation | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Time required to reach maximal dilation after cuff deflation.Unit of Measure: seconds |
| Basal brachial artery diameter | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Baseline diameter of the brachial artery before cuff inflation.Unit of Measure: mm |
| Peak brachial artery diameter | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Maximal diameter of the brachial artery after reactive hyperemia.Unit of Measure: mm |
| Absolute flow-mediated dilation (FMDabs) | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Absolute change in diameter, calculated as peak diameter minus basal diameter.Unit of Measure: mm |
| Standardized FMD | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Flow-mediated dilation adjusted for relevant covariates (e.g., shear stress, baseline diameter) according to standard protocols.Unit of Measure: % |
| Body weight | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Body weight measured by bioelectrical impedance analysis (InBody device).Unit of Measure: kg |
| Body fat percentage | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Body fat percentage measured by bioelectrical impedance analysis (InBody device).Unit of Measure: % |
| Body mass index (BMI) | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Body mass index calculated from weight and height measured by bioelectrical impedance analysis (InBody device).Unit of Measure: kg/m² |
| Basal metabolic rate (BMR) | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Basal metabolic rate estimated by bioelectrical impedance analysis (InBody device).Unit of Measure: kcal |
| Waist circumference | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Waist circumference measured by bioelectrical impedance analysis (InBody device).Unit of Measure: cm |
| Visceral fat area | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Visceral fat area measured by bioelectrical impedance analysis (InBody device). Unit of Measure: cm² |
| Skeletal muscle mass | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Skeletal muscle mass measured by bioelectrical impedance analysis (InBody device).Unit of Measure: kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure (SBP) | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Systolic blood pressure measured using an electronic sphygmomanometer.Unit of Measure: mmHg |
| Serum high-density lipoprotein (HDL) cholesterol concentration | Measured at baseline and post-intervention (after 6-8 weeks). | Fasting serum HDL cholesterol concentration measured from blood samples. Unit of Measure: mmol/L |
| Diastolic blood pressure (DBP) | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Diastolic blood pressure measured using an electronic sphygmomanometer. Unit of Measure: mmHg |
| Heart rate | Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks). | Heart rate measured using an electronic sphygmomanometer.Unit of Measure: bpm (beats per minute) |
| Serum low-density lipoprotein (LDL) cholesterol concentration | Measured at baseline and post-intervention (after 6-8 weeks). | Fasting serum LDL cholesterol concentration measured from blood samples. Unit of Measure: mmol/L |
| Serum total cholesterol concentration | Measured at baseline and post-intervention (after 6-8 weeks). | Fasting serum total cholesterol concentration measured from blood samples. Unit of Measure: mmol/L |
| HDL/LDL cholesterol ratio | Measured at baseline and post-intervention (after 6-8 weeks). | Ratio of serum HDL cholesterol to LDL cholesterol calculated from fasting blood samples.Unit of Measure: ratio (dimensionless) |
| Serum triglyceride concentration | Measured at baseline and post-intervention (after 6-8 weeks). | Fasting serum triglyceride concentration measured from blood samples.Unit of Measure: mmol/L |
Contacts
CONTACTXINCHEN ZHANG
PRINCIPAL_INVESTIGATORYANXIA WANG, PhD
Weifang Medical University(Renamed Shandong Second Medical University)
Outcome results
None listed