Obese College StudentsNCT06848985
Impact of Combined Aerobic and Resistance Exercise on Autonomic Function and Cardiopulmonary Endurance in Obese College Students
A study testing Aerobic combined with Resistance exercise in people with Obese College Students and Aerobic Exercise Combined with Resistance Exercise, run by Capital University of Physical Education and Sports, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese College Students, Aerobic Exercise Combined with Resistance Exercise
- What is being tested?
- Aerobic combined with Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2023to 24 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
China1 site
Capital University Of Physical Education And Sports
Beijing, Beijing Municipality, 100080
About this study
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.
- Being tested
- Aerobic combined with Resistance exercise
- Keywords
- Aerobic exercise combined with resistance exercises, Cardiorespiratory endurance, Autonomic function, Obese college students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic combined with Resistance exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 30 participants underwent a 16-week program of aerobic (60%-70% HRmax for 40 minutes) and resistance exercises (65%-70% RM for 30 minutes). Receives: Behavioral: Aerobic combined with Resistance exercise |
| Control Group | No intervention | 30 participants maintained normal physical activity without additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic function
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.
Measured: From enrollment to the end of treatment at 16 weeks
Cardiorespiratory endurance
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.
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (2)
The Functional Movement Screen (FMS) score
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.
Measured: From enrollment to the end of treatment at 16 weeks
Body composition
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.
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start2 Sep 2023
- Primary completion24 Dec 2023
- Study completion24 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese College StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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). Ultimately, 60 students who met these criteria were selected for the study, divided into an experimental group of 30 and a control group of 30. The study primarily utilized a combined exercise regimen of aerobic and resistance exercises, conducted three times a week over a period of 16 weeks. The control group maintained their normal physical activity levels without any additional intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital University of Physical Education and Sports, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bai Shuang, Beijing Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848985
- Sponsor's protocol ID
- No.155223005
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combined Aerobic and Resistance Exercise on Autonomic Function and Cardiopulmonary Endurance in Obese College Students
- ClinicalTrials.gov ID
- NCT06848985
- Acronym / sponsor ID
- No.155223005
- Keywords
- Aerobic exercise combined with resistance exercises, Cardiorespiratory endurance, Autonomic function, Obese college students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Capital University of Physical Education and Sports, ChinaUniversity, hospital or other
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 24 Dec 2023 (actual)
- Study completion
- 24 Dec 2023 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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). Ultimately, 60 students who met these criteria were selected for the study, divided into an experimental group of 30 and a control group of 30. The study primarily utilized a combined exercise regimen of aerobic and resistance exercises, conducted three times a week over a period of 16 weeks. The control group maintained their normal physical activity levels without any additional intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Aerobic combined with Resistance exercise30 participants underwent a 16-week program of aerobic (60%-70% HRmax for 40 minutes) and resistance exercises (65%-70% RM for 30 minutes). |
| Control Group | No intervention | –30 participants maintained normal physical activity without additional interventions. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic combined with Resistance exerciseParticipants 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. | Behavioural | Experimental Group |
Primary outcome
Autonomic function
Time frame: From enrollment to the end of treatment at 16 weeks
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.
Cardiorespiratory endurance
Time frame: From enrollment to the end of treatment at 16 weeks
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.
2 secondary outcomes
The Functional Movement Screen (FMS) score
Time frame: From enrollment to the end of treatment at 16 weeks
Body composition
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Yes
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Exercise Adherence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic combined with Resistance exercise in people with Obese College Students and Aerobic Exercise Combined with Resistance Exercise, run by Capital University of Physical Education and Sports, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic function (time frame: From enrollment to the end of treatment at 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.