The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease

NCT ID: NCT06338449

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-13
• Study Completion Date: 2022-12-31

Brief Summary

The purpose of this clinical trial is to investigate which exercise regimen is more effective in improving non-alcoholic fatty liver disease (NAFLD) in a young population. The primary questions it aims to answer are:

Does aerobic training, resistance training, or a combination of both help improve liver function and glycemic and lipid parameters in NAFLD patients? Which of these three exercise regimens is more effective in improving the aforementioned parameters? Is the improvement in liver function related to bile acid metabolism?

Participants will:

Engage in physical exercise 4-5 times per week for two consecutive months, following a predefined exercise regimen.

Have blood samples collected to test for glucose, lipids, liver function, and other parameters before starting the exercise program and after two months of completing the regimen.

Conditions

Non-alcoholic Fatty Liver Disease NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic training (AT)

Aerobic exercise can include activities like swimming, running, or cycling. Scientifically, aerobic exercise is defined as any activity that uses large muscle groups, can be maintained continuously, and is rhythmic in nature. It improves the efficiency of the cardiovascular, respiratory, and circulatory systems by delivering oxygen more efficiently to the body. According to reports, aerobic exercise can help reduce fat and improve liver function.

Group Type: ACTIVE_COMPARATOR

Aerobic training (AT)

Intervention Type: BEHAVIORAL

An exercise program was developed by a full-time physical education teacher, with all group exercises conducted at the outdoor track and field facility of Xuzhou Medical University. Participants in the aerobic training group, after completing a warm-up, were required to perform moderate-intensity aerobic running for 60 minutes per session, 4-5 times a week. The exercise intensity was set to reach 50%-70% of the maximum heart rate (Maximum heart rate = 220 - age). The exercise sessions were scheduled in the evening after dinner, from 17:30 to 19:00.All participants were continuously intervened for 8 weeks.

Resistance training (RT)

Resistance exercise is a form of physical activity that is designed to improve muscular fitness by exercising a muscle or a muscle group against external resistance. This includes traditional weightlifting, using weight machines, resistance band exercises, bodyweight exercises, and other activities designed to build muscle strength, endurance, and size. The key principle is the muscle's ability to contract against resistance: using weights, resistance bands, or one's own body weight, the muscle is challenged, leading to muscular adaptation and growth, enhancing strength and endurance. According to reports, resistance exercise can also help improve liver function.

Group Type: ACTIVE_COMPARATOR

Resistance training (RT)

Intervention Type: BEHAVIORAL

Participants in the resistance training group were required to complete moderate-intensity resistance exercises 4-5 times per week. Each session included a warm-up, followed by exercises such as knee lifts with torso twists, knee-to-hand taps under the hips, jumping jacks, burpees, sit-ups, planks, and squats. The routine was structured to perform 5-6 exercises per session, with 6-8 repetitions for each set. There was a 30-second rest interval between sets, and the total exercise time was 60 minutes. The timing for these exercise sessions was the same as for the AT group, conducted in the evening after dinner.All participants were continuously intervened for 8 weeks.

Combined aerobic and resistance training (AT + RT)

The combination of aerobic exercise and resistance exercise.

Group Type: ACTIVE_COMPARATOR

Combined aerobic and resistance training (AT + RT)

Intervention Type: BEHAVIORAL

Participants in the combined aerobic and resistance training (AT+RT) group started their sessions with a warm-up, followed by 30 minutes of aerobic running. After the aerobic training, they engaged in resistance training. The resistance training regimen was the same as that for the RT group, except that the duration of the resistance training was shorter. The total duration of the exercise session was 60 minutes.All participants were continuously intervened for 8 weeks.

Interventions

Aerobic training (AT)

An exercise program was developed by a full-time physical education teacher, with all group exercises conducted at the outdoor track and field facility of Xuzhou Medical University. Participants in the aerobic training group, after completing a warm-up, were required to perform moderate-intensity aerobic running for 60 minutes per session, 4-5 times a week. The exercise intensity was set to reach 50%-70% of the maximum heart rate (Maximum heart rate = 220 - age). The exercise sessions were scheduled in the evening after dinner, from 17:30 to 19:00.All participants were continuously intervened for 8 weeks.

Intervention Type: BEHAVIORAL

Resistance training (RT)

Participants in the resistance training group were required to complete moderate-intensity resistance exercises 4-5 times per week. Each session included a warm-up, followed by exercises such as knee lifts with torso twists, knee-to-hand taps under the hips, jumping jacks, burpees, sit-ups, planks, and squats. The routine was structured to perform 5-6 exercises per session, with 6-8 repetitions for each set. There was a 30-second rest interval between sets, and the total exercise time was 60 minutes. The timing for these exercise sessions was the same as for the AT group, conducted in the evening after dinner.All participants were continuously intervened for 8 weeks.

Intervention Type: BEHAVIORAL

Combined aerobic and resistance training (AT + RT)

Participants in the combined aerobic and resistance training (AT+RT) group started their sessions with a warm-up, followed by 30 minutes of aerobic running. After the aerobic training, they engaged in resistance training. The resistance training regimen was the same as that for the RT group, except that the duration of the resistance training was shorter. The total duration of the exercise session was 60 minutes.All participants were continuously intervened for 8 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Body fat percentage >20% or BMI >24
• The diagnostic result of abdominal ultrasonography is fatty liver
• No regular exercise under guidance in the past 3 months
• No medication taken in the last month
• No binge eating or heavy drinking in the past two weeks

Exclusion Criteria

• Long history of alcohol consumption, equivalent to more than 30g/day of ethanol
• Viral hepatitis
• History of autoimmune or genetic diseases
• History of drug-induced liver disease
• History of total parenteral nutrition
• History of cardiovascular, respiratory, or other diseases that necessitate avoidance of intense physical activity.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yang Qiang

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Outdoor track and field facility of Xuzhou Medical University

Xuzhou, Jiangsu, China

Countries

China

References

Shi J, Cui J, Zheng T, Han X, Wang B, Wang W, Zhu C, Fang C, Zhou X, Cong N, Yin X, Yang Q. Comparative effects of aerobic and resistance exercise on bile acid profiles and liver function in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2025 Apr 10;25(1):239. doi: 10.1186/s12876-025-03826-x.

Reference Type: DERIVED

PMID: 40211236 (View on PubMed)

Other Identifiers

XZMU-2022-ZK068

Identifier Type: -

Identifier Source: org_study_id