- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07558421
The Effects of Exercise Snacks on Endothelial Function and Body Composition in Overweight Individuals
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: XINCHEN ZHANG
- Telefonnummer: +8615094866869
- E-Mail: zhangxinchen2001@126.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
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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|
Experimental: 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.
|
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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|
Experimental: 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.
|
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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Kein Eingriff: control group
The participants did not undergo any form of exercise intervention and maintained their usual activity patterns.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Flow-mediated dilation (FMD, relative percentage)
Zeitfenster: 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: %
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Body fat mass
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Time to peak dilation
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Basal brachial artery diameter
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Peak brachial artery diameter
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Absolute flow-mediated dilation (FMDabs)
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Standardized FMD
Zeitfenster: 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: %
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Body weight
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Body fat percentage
Zeitfenster: 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: %
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Body mass index (BMI)
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Basal metabolic rate (BMR)
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Waist circumference
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Visceral fat area
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Skeletal muscle mass
Zeitfenster: 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).
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Systolic blood pressure (SBP)
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Serum high-density lipoprotein (HDL) cholesterol concentration
Zeitfenster: Measured at baseline and post-intervention (after 6-8 weeks).
|
Fasting serum HDL cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
|
Measured at baseline and post-intervention (after 6-8 weeks).
|
|
Diastolic blood pressure (DBP)
Zeitfenster: 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
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Heart rate
Zeitfenster: 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)
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Serum low-density lipoprotein (LDL) cholesterol concentration
Zeitfenster: Measured at baseline and post-intervention (after 6-8 weeks).
|
Fasting serum LDL cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
|
Measured at baseline and post-intervention (after 6-8 weeks).
|
|
Serum total cholesterol concentration
Zeitfenster: Measured at baseline and post-intervention (after 6-8 weeks).
|
Fasting serum total cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
|
Measured at baseline and post-intervention (after 6-8 weeks).
|
|
HDL/LDL cholesterol ratio
Zeitfenster: 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)
|
Measured at baseline and post-intervention (after 6-8 weeks).
|
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Serum triglyceride concentration
Zeitfenster: Measured at baseline and post-intervention (after 6-8 weeks).
|
Fasting serum triglyceride concentration measured from blood samples.Unit of Measure: mmol/L
|
Measured at baseline and post-intervention (after 6-8 weeks).
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: YANXIA WANG, PhD, Weifang Medical University(Renamed Shandong Second Medical University)
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026YX160
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