- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06848985
Impact of Combined Aerobic and Resistance Exercise on Autonomic Function and Cardiopulmonary Endurance in Obese College Students
This study explores the potential link between aerobic exercise combined with resistance training and improvements in cardiopulmonary function in obese individuals, focusing particularly on the influence of autonomic nerve function. By examining the effects of combined exercise on obese college students, this research aims to elucidate the critical role that autonomic nerve function improvement plays in enhancing cardiopulmonary function in this demographic.
The study primarily utilized a combined exercise regimen of aerobic and resistance exercises, conducted three times a week over a period of 16 weeks. One session was held during class hours, with the remaining two sessions scheduled during free time in the university gym. Aerobic exercises included the use of treadmills and elliptical machines, with intensity maintained at 60%-70% of the maximum heart rate (calculated as 220 minus age), for a total of 40 minutes per session (5 minutes of warm-up, 30 minutes of main exercise, and 5 minutes of cool-down). Heart rate monitors were used to ensure the intensity was maintained; resistance exercises involved gym equipment and bodyweight exercises, including the use of a pec deck machine, lat pull-downs, chest presses, bicep curls, tricep extensions, leg curls, and leg presses. The intensity of resistance exercises was set at about 65%-70% of one repetition maximum (1RM), with each session consisting of three sets of 6-8 repetitions and lasting for 30 minutes.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100080
- Capital University of Physical Education And Sports
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Obese college students aged 18-22 were recruited from a university in Beijing to participate in a public elective course on exercise for weight loss and slimming at the Capital University of Physical Education and Sport (CUPES). The inclusion criteria included a BMI of ≥28 kg/m^2, no history of chronic diseases such as cardiovascular or metabolic diseases, no psychiatric conditions (e.g., depression, anxiety disorder, obsessive-compulsive disorder), and no physical disabilities or movement disorders (such as bone and joint diseases).
Exclusion Criteria:
- The exclusion criteria include individuals with diseases that may affect training (such as cardiovascular diseases, respiratory diseases, and musculoskeletal disorders), as well as those diagnosed with mental disorders (such as depression, anxiety, obsessive-compulsive disorder, etc.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
30 participants underwent a 16-week program of aerobic (60%-70% HRmax for 40 minutes) and resistance exercises (65%-70% RM for 30 minutes).
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Participants are required to perform aerobic and resistance exercises.
Aerobic exercises included the use of treadmills and elliptical machines, with intensity maintained at 60%-70% of the maximum heart rate (calculated as 220 minus age), for a total of 40 minutes per session (5 minutes of warm-up, 30 minutes of main exercise, and 5 minutes of cool-down).
Heart rate monitors were used to ensure the intensity was maintained; resistance exercises involved gym equipment and bodyweight exercises, including the use of a pec deck machine, lat pull-downs, chest presses, bicep curls, tricep extensions, leg curls, and leg presses.
The intensity of resistance exercises was set at about 65%-70% of one repetition maximum (1RM), with each session consisting of three sets of 6-8 repetitions and lasting for 30 minutes.
|
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No Intervention: Control Group
30 participants maintained normal physical activity without additional interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autonomic function
Time Frame: From enrollment to the end of treatment at 16 weeks
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Autonomic function was assessed using the Pushikang FLY-2 autonomic physiological monitor.
Participants were required to abstain from caffeinated and alcoholic beverages for 12 hours and from strenuous physical activity for 48 hours prior to the test.
The testing was conducted between 8:00 a.m. and 11:00 a.m. in a controlled environment with temperatures maintained at 22-24°C.
The test duration was 5 minutes, during which participants sat quietly and refrained from speaking.
Autonomic nerve function parameters were recorded using finger photoplethysmography to measure pulse wave changes in a resting state.
Data was processed using Beijing Fourier's autonomic nerve response analysis software (ANS-1, V6.6).
Time-domain analysis focused on the mean interval between heartbeats to reflect sympathetic/vagal modulation, and the variance of these intervals indicated the overall variability of cardiac function, providing critical prognostic information.
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From enrollment to the end of treatment at 16 weeks
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Cardiorespiratory endurance
Time Frame: From enrollment to the end of treatment at 16 weeks
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Cardiopulmonary function was evaluated using the cardiopulmonary exercise test (CPET, Schiller) on a Rehab-B exercise treadmill.
To ensure test accuracy, participants were instructed to refrain from physical activity on the day prior to the test and to avoid alcohol, caffeinated beverages, and food for 8 hours before testing and during the first 3 hours of the test day.
The exercise commenced with a 3-minute rest followed by a gradual load phase, allowing participants to reach voluntary fatigue within 8 to 12 minutes, and then continue at maximum tolerance for an additional 3 minutes.
The exercise protocol followed the Bruce protocol, with incremental loads adjusted for gender: 25 W/min for males and 15 W/min for females.
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From enrollment to the end of treatment at 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Functional Movement Screen (FMS) score
Time Frame: From enrollment to the end of treatment at 16 weeks
|
The Functional Movement Screening (FMS) is a standardized tool used to assess the functional motor abilities of individuals.
It consists of seven tests (squatting, stepping, lunging, reaching, leg raising, push-up, and rotary stability) that balance flexibility and stability, allowing medical and fitness professionals to identify problems such as weakness, imbalance, asymmetry, and movement limitations.
In the FMS, each action is scored from 0 to 3: a score of 3 indicates the individual can perform the movement standardly and stably without compensation; a score of 2 signifies that the movement can be completed, albeit with some instability or compensatory behavior; a score of 1 indicates an inability to perform the movement according to the standards.
Research has shown that lower FMS scores correlate with a higher risk of injury.
Typically, a threshold score of 14 is used, with individuals scoring below this level considered at greater risk of injury.
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From enrollment to the end of treatment at 16 weeks
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Body composition
Time Frame: From enrollment to the end of treatment at 16 weeks
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Body composition was assessed using the InBody760 (Ver.
LookinBody120.4.0.0.7) bioelectrical impedance analyzer.
Measurements were taken in the early morning, with subjects fasting and in a controlled temperature environment (22-24℃), providing immediate readings of body mass index (BMI), body fat percentage, waist-to-hip ratio, visceral fat area.
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From enrollment to the end of treatment at 16 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No.155223005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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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