A Multicentre Clinical Study on the Correlation Between Exercise and Hyperuricemia

This project is a multi-center clinical study on the correlation between exercise and hyperuricemia. The purpose is to explore the correlation between exercise and hyperuricemia, find out the metabolic rule of uric acid after exercise, and provide scientific evidence and clinical guidance for how to exercise scientifically and reasonably in patients with hyperuricemia. This trial is a multicenter, prospective, randomized controlled clinical trial with 100 participants. Inclusion criteria: 1. Patients with hyperuricemia (fasting uric acid > 420μmol/L twice on different days); 2. Men aged between 18 and 35; 3. Able to complete baseline fitness test (3000m run time less than 14 minutes); 4. Fully informed consent, signed informed consent exclusion criteria: 1. Heart, liver and kidney insufficiency; 2. Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, diabetes mellitus; 3. Patients with secondary hyperuricemia caused by medicine or other diseases; 4. People who take uric acid lowering drugs; 5. People with related motor dysfunction or other factors that can easily cause discomfort after exercise 6. Those with mental disorders or communication disorders, and those who do not cooperate during the experiment A total of 100 subjects were included according to the scheduling criteria. SPSS23.0 software was used to generate a random number table, and random numbers were calculated according to 1: The results of the groups were sealed in opaque envelopes, and the envelopes were kept by A third party responsible for randomization. According to the contents of the envelopes, the subjects were divided into group A, which exercised for 24 hours after 3000m exercise, and group B, which exercised for 48 hours after 3000m exercise. During the 48-hour observation period after each exercise, the changes of uric acid after exercise were explored. To provide scientific evidence and clinical guidance for patients with hyperuricemia how to exercise scientifically and rationally.

Patients must meet all inclusion and exclusion criteria to be eligible to participate in the study. After determining patients' eligibility for the study, the researcher should fully explain the nature, purpose, risks and benefits of the study to the subjects before the study, and assure the patients that they have the right to withdraw at any time after agreeing to participate in the study, and the subjects should sign a written informed consent after fully considering and agreeing to participate in the study. The process of obtaining informed consent should be correctly recorded in all case report forms in this study.

Baseline data such as blood uric acid, blood biochemistry, blood routine, urine routine, uric acid and demographic characteristics were collected after the patients were enrolled.

The patients were randomly divided into two groups: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A.

Within 48 hours after each 3000m exercise, the subjects' blood uric acid was detected immediately after exercise (within 5 minutes), 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, 36 hours, 48 hours. Blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid and other information were collected again 24 hours after intervention.

From January 2024 to February 2024, we plan to draft clinical study protocols, investigator manuals, case reports, informed consent forms and other documents, and submit them to the Ethics Committee of the research sponsor for review and approval; February 2024 - March 2024: Complete the training of all researchers and officially start the research; March 2024 - August 2024: Participants were enrolled for the experiment; August 2024 - November 2024: collate and collect data, conduct statistical analysis, and confirm research results

Study Overview

• Status: Recruiting
• Conditions: Hyperuricemia
• Intervention / Treatment: Behavioral: Run 3000 meters

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: XiangLiang Meng; Phone Number: +8613730192056; Email: 997815173@qq.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: XiangLiang Meng; Phone Number: +8613730192056; Email: 997815173@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with hyperuricemia (fasting uric acid > 420μmol/L twice on different days);
• Men aged between 18 and 35;
• Able to complete baseline fitness test (3000m run time less than 14 minutes);
• Fully informed consent, sign informed consent

Exclusion Criteria:

• Heart, liver and kidney insufficiency;
• Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, diabetes mellitus;
• Patients with secondary hyperuricemia caused by medicine or other diseases;
• People who take uric acid lowering drugs;
• People with related motor dysfunction or other factors that can easily cause discomfort after exercise
• Those with mental disorders or communication disorders, and those who do not cooperate during the experiment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (two 3000m runs 24 hours apart); Run a second 3000m run 24 hours after completing the first 3000m run	Behavioral: Run 3000 meters; Participants in both groups were asked to do two 3,000-meter runs at different intervals
Experimental: Group B (two 3000m runs 48 hours apart); Run a second 3000m run 48 hours after completing the first 3000m run	Behavioral: Run 3000 meters; Participants in both groups were asked to do two 3,000-meter runs at different intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uric acid metabolism in patients with hyperuricemia after exercise	Monitoring changes in uric acid levels after exercise	1 week

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Air Force 986 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: KY20242030-C-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No