NCT06848985

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 18, 2025

Last Update Submit

February 21, 2025

Conditions

Keywords

Aerobic exercise combined with resistance exercisesCardiorespiratory enduranceAutonomic functionObese college students

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (2)

  • The Functional Movement Screen (FMS) score

    From enrollment to the end of treatment at 16 weeks

  • Body composition

    From enrollment to the end of treatment at 16 weeks

Study Arms (2)

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).

Behavioral: Aerobic combined with Resistance exercise

Control Group

NO INTERVENTION

30 participants maintained normal physical activity without additional interventions.

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years - 22 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital University Of Physical Education And Sports

Beijing, Beijing Municipality, 100080, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 27, 2025

Study Start

September 2, 2023

Primary Completion

December 24, 2023

Study Completion

December 24, 2023

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations