- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07558421
The Effects of Exercise Snacks on Endothelial Function and Body Composition in Overweight Individuals
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: XINCHEN ZHANG
- 전화번호: +8615094866869
- 이메일: zhangxinchen2001@126.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age: 18-35 years old (male, female);
- Clear consciousness, stable vital signs;
- Able to understand and follow simple instructions;
- No regular exercise for at least 3 months;
- BMI ≥ 24 kg/m2.
Exclusion Criteria:
- There are other serious diseases, such as tumors;
- There are other neurological diseases;
- There are serious diseases that simultaneously affect the heart, liver, kidneys, endocrine system or hematopoietic system;
- There is a history of alcohol or drug abuse;
- Participated in other clinical trials that might affect the results of this study;
- There are other neurological or musculoskeletal diseases, with pain worsening with exercise;
- It is forbidden to engage in physical training.
- 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.;
- Uncontrolled hypertension;
- Severe pulmonary diseases, such as uncontrolled asthma, acute exacerbation of chronic obstructive pulmonary disease, interstitial lung disease with significant exercise limitation;
- Severe joint and bone diseases, acute soft tissue injuries, fractures that have not healed, etc., making it impossible to complete the prescribed exercise load;
- Presence of bleeding tendencies, coagulation dysfunction, or within the past 1 month, there has been major bleeding or a history of surgery;
- The investigator judges that there are any other situations that may affect the safety of the subjects or the results of the trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Short-term stair climbing exercise snack group
Participants perform short climbs of the stairs 4 to 5 times a day.
Each climb involves going up 5 floors (approximately 1 minute), and there is a minimum interval of at least 1 hour between each climb.
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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.
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실험적: Long-duration stair climbing exercise snack group
Participants climbed the ladder 4 to 5 times a day.
Each climb consisted of 2 to 3 sets (each set involved climbing 5 floors, with a rest period of no more than 1 minute between sets), and the total number of floors climbed in a single session was 10 or 15.
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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.
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실험적: Moderate-intensity continuous exercise
The participants engaged in moderate-intensity running training for 3 to 5 days per week, with each session lasting for 30 minutes.
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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.
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간섭 없음: control group
The participants did not undergo any form of exercise intervention and maintained their usual activity patterns.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Flow-mediated dilation (FMD, relative percentage)
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Flow-mediated dilation expressed as a percentage of the baseline brachial artery diameter.Unit of Measure: %
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Body fat mass
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Body fat mass measured by bioelectrical impedance analysis (InBody device).
Unit of Measure: kg
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Time to peak dilation
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Time required to reach maximal dilation after cuff deflation.Unit of Measure: seconds
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Basal brachial artery diameter
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Baseline diameter of the brachial artery before cuff inflation.Unit of Measure: mm
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Peak brachial artery diameter
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Maximal diameter of the brachial artery after reactive hyperemia.Unit of Measure: mm
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Absolute flow-mediated dilation (FMDabs)
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Absolute change in diameter, calculated as peak diameter minus basal diameter.Unit of Measure: mm
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Standardized FMD
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Flow-mediated dilation adjusted for relevant covariates (e.g., shear stress, baseline diameter) according to standard protocols.Unit of Measure: %
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Body weight
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Body weight measured by bioelectrical impedance analysis (InBody device).Unit of Measure: kg
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Body fat percentage
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Body fat percentage measured by bioelectrical impedance analysis (InBody device).Unit of Measure: %
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Body mass index (BMI)
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Body mass index calculated from weight and height measured by bioelectrical impedance analysis (InBody device).Unit of Measure: kg/m²
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Basal metabolic rate (BMR)
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Basal metabolic rate estimated by bioelectrical impedance analysis (InBody device).Unit of Measure: kcal
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Waist circumference
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Waist circumference measured by bioelectrical impedance analysis (InBody device).Unit of Measure: cm
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Visceral fat area
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Visceral fat area measured by bioelectrical impedance analysis (InBody device).
Unit of Measure: cm²
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Skeletal muscle mass
기간: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Systolic blood pressure (SBP)
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Systolic blood pressure measured using an electronic sphygmomanometer.Unit of Measure: mmHg
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Serum high-density lipoprotein (HDL) cholesterol concentration
기간: Measured at baseline and post-intervention (after 6-8 weeks).
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Fasting serum HDL cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
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Measured at baseline and post-intervention (after 6-8 weeks).
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Diastolic blood pressure (DBP)
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Diastolic blood pressure measured using an electronic sphygmomanometer.
Unit of Measure: mmHg
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Heart rate
기간: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Heart rate measured using an electronic sphygmomanometer.Unit of Measure: bpm (beats per minute)
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Serum low-density lipoprotein (LDL) cholesterol concentration
기간: Measured at baseline and post-intervention (after 6-8 weeks).
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Fasting serum LDL cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
|
Measured at baseline and post-intervention (after 6-8 weeks).
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Serum total cholesterol concentration
기간: Measured at baseline and post-intervention (after 6-8 weeks).
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Fasting serum total cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
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Measured at baseline and post-intervention (after 6-8 weeks).
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HDL/LDL cholesterol ratio
기간: Measured at baseline and post-intervention (after 6-8 weeks).
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Ratio of serum HDL cholesterol to LDL cholesterol calculated from fasting blood samples.Unit of Measure: ratio (dimensionless)
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Measured at baseline and post-intervention (after 6-8 weeks).
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Serum triglyceride concentration
기간: Measured at baseline and post-intervention (after 6-8 weeks).
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Fasting serum triglyceride concentration measured from blood samples.Unit of Measure: mmol/L
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Measured at baseline and post-intervention (after 6-8 weeks).
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공동 작업자 및 조사자
수사관
- 수석 연구원: YANXIA WANG, PhD, Weifang Medical University(Renamed Shandong Second Medical University)
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
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QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026YX160
개별 참가자 데이터(IPD) 계획
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