- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06849453
Effects of Exercise Snacks and Sprint Interval Training in Overweight Adults
Effects of Exercise Snacks and Sprint Interval Training on Cardiovascular Function in Overweight Adults: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Engaging in regular physical activity has been shown to induce a range of beneficial physiological and psychological adaptations, including improved cardiorespiratory fitness, body composition, cardiovascular function, and reductions in negative emotions. However, global participation rates in physical activity remain suboptimal, with little significant improvement. Interviews and surveys have identified several potential barriers to low physical activity levels, with limitations such as 'lack of time, equipment, and facilities' often cited as the main perceived obstacles. Therefore, exploring the minimum effective dose of exercise in real-world settings is essential.
This study will employ a randomized clinical trial to examine the effectiveness and acceptability of two low-volume, high-intensity stair climbing exercises in overweight adults. It adopts a single-blind, parallel randomized design, with the intervention commencing immediately after the initial evaluation and randomization, following a pre-treatment/post-test framework. Eligible participants were recruited via convenience sampling and randomly assigned to one of three groups (one control group and two experimental groups):
- A control group that will not receive any treatment.
- Two experimental groups (ES and SIT), which will undergo a stair climbing-based physical training program following the initial evaluation. The two exercise interventions are designed with equal exercise volume, with the only difference being the rest (recovery) time between stair sprints. All exercise sessions are conducted under the supervision of professionals.
The aim of this study is twofold: First, to explore the impact of ES and SIT on cardiorespiratory fitness, body composition, and cardiovascular function in overweight adults. Second, to examine the acceptability of two low-volume, high-intensity stair climbing exercises by assessing participants' (1) acceptability, (2) reactions during the interventions, (3) enjoyment and affective valence during exercise, and (4) intentions at the end.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peizhen Zhang
- Phone Number: 01062989581
- Email: zhpzh@bsu.edu.cn
Study Locations
-
-
-
Beijing, China
- School of Sports Medicine and Rehabilitation, Beijing Sport University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women aged between 18 and 35 years;
- Overweight but not obese (BMI ≥24 and ≤ 28 kg/m2);
- Physically inactive (3 or less bouts of purposeful exercise per week);
- Ability to understand the research details and voluntarily sign the informed consent form;
- Non-smoker (for >5 years);
- Body weight has been stable over the past six months, with no recent weight gain or loss behaviors;
- Healthy (see exclusion criteria).
Exclusion Criteria:
- Any chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, peripheral arterial disease, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through preliminary screening;
- Individuals with a history of bone, joint or neuromuscular problems or a current musculoskeletal injury ascertained through preliminary screening;
- Abnormal electrocardiogram (ECG) results;
- Currently taking medication that may affect physiological testing;
- Contraindications to exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Active Comparator: Exercise snacks group
|
Exercise snacks on the stairs for 8 weeks.
|
|
Active Comparator: Sprint interval training group
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Sprint interval training on the stairs for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiorespiratory fitness
Time Frame: 8 weeks
|
The change of maximal oxygen uptake (VO2max) before and after intervention.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition
Time Frame: 8 weeks
|
The change of body composition indexes (including fat mas, lean body mass, percentage of body fat) before and after intervention.
|
8 weeks
|
|
Lipid profile
Time Frame: 8 weeks
|
The changes in concentrations of high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, and triglyceride before and after intervention.
|
8 weeks
|
|
Endothelial function
Time Frame: 8 weeks
|
The change of brachial Flow-Mediated Dilation (FMD) before and after intervention.
Endothelial function will be assessed by FMD.
|
8 weeks
|
|
Arterial stiffness
Time Frame: 8 weeks
|
The changes of brachial-ankle pulse wave velocity and ankle brachial index before and after intervention.
|
8 weeks
|
|
Resting blood pressure
Time Frame: 8 weeks
|
The change of blood pressure (including systolic and diastolic blood pressure) before and after intervention.
|
8 weeks
|
|
Resting heart rate
Time Frame: 8 weeks
|
The change of resting heart rate before and after intervention.
|
8 weeks
|
|
Waist Circumference
Time Frame: 8 weeks
|
The change of waist circumference before and after intervention.
|
8 weeks
|
|
Hip Circumference
Time Frame: 8 weeks
|
The change of hip circumference before and after intervention.
|
8 weeks
|
|
Body Mass Index (BMI )
Time Frame: 8 weeks
|
The change of BMI before and after intervention.
BMI is calculated from the formula, Weight (kg) / Height2 (m2).
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the intervention
Time Frame: 8 weeks
|
Intervention acceptability will be assessed using a theoretical framework of acceptability (TFA) questionnaire, completed only at the follow-up assessment.
The seven domains of the TFA, along with overall acceptability, are measured using an 8-item questionnaire.
The scale scores range from 0 to 5 with high scores indicating greater acceptability, and the total score representing the mean average of 7 individual domains of acceptability (each also rated 0-5).
|
8 weeks
|
|
Physical Activity Enjoyment Scale (PACES)
Time Frame: 8 weeks
|
A modified version of the PACES will be used, the PACES scale was modified by removing 1 irrelevant item ('I was very/not at all absorbed in the activity').
The 17 items are scored on a 7-point Likert scale, resulting in an overall enjoyment score between 17 (not enjoyable), 68 (neutral), and 119 (enjoyable).
|
8 weeks
|
|
Intention Questionnaire
Time Frame: 8 weeks
|
Intention questionnaire will be used after the 8 weeks intervention by a seven-point scale ranging from "Most likely never do this form of physical activity again (1)" to "Will likely do this three times per week every week (7)".
|
8 weeks
|
|
Exercise Enjoyment Scale
Time Frame: 4 weeks and 8 weeks
|
Exercise enjoyment scale will be measured before, middle, and after intervention.
The form will be presented to participants on a scale of 1 = 'not at all' to 7 = 'extremely,' and they will be asked, 'How much did you enjoy this exercise session?'
|
4 weeks and 8 weeks
|
|
Feeling Scale
Time Frame: 4 weeks and 8 weeks
|
Feeling scale will be measured before, middle, and after intervention.
The one-item Feeling Scale will be used to measure general affective valence (i.e., pleasure and displeasure), participants will respond to the question 'How are you feeling right now?' (-5 = very bad to +5 = very good)
|
4 weeks and 8 weeks
|
|
Rating of perceived exertion (RPE)
Time Frame: 4 weeks and 8 weeks
|
Participants' RPE will be immediately assessed by Borg's Category-Ratio 10 scale after training sessions before, middle, and after intervention.
The scale scores range from 0 to 10, with higher scores indicating greater perceived exertion.
|
4 weeks and 8 weeks
|
|
Heart rate
Time Frame: 4 weeks and 8 weeks
|
Mean and maximum heart rate of the intervention group will be monitored during each sprint.
|
4 weeks and 8 weeks
|
|
Depression Anxiety Stress Scale-21 (DASS-21)
Time Frame: 8 weeks
|
DASS-21 will be used before and after intervention.
The scale has 21 questions, each question required participants to rate their experiences on a 4-point scale, where 0 indicated "did not apply to me at all", 1 indicated "applied to me to some degree or some of the time", 2 indicated "applied to me to a considerable degree or a good part of the time", and 3 indicated "applied to me very much or most of the time".
The total scale scores range from 0 to 63, with higher scores indicating worse outcomes.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EESSITOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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