An Exploratory Clinical Study on the Protective Effect of Cycling on the Ankle Joint in Gout

This study divided the enrolled gout patients into a jogging group and a cycling group to investigate 1）the effectiveness of cycling intervention in reducing the recurrence risk of gouty ankle arthritis compared with jogging. 2) To clarify the influence of different exercise patterns on the ultrasonic manifestations of gouty ankle arthritis; 3) Clarify the impact of different exercise methods on the blood uric acid levels of gout patients;

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Activity; Gout Arthritis; Cycling
• Intervention / Treatment: Drug: Urate-lowering therapy (ULT); Behavioral: Jogging; Behavioral: Cycling

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• meets the diagnostic criteria for gout of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) in 2015
• There have been two histories of gout attacks on either side of the ankle joint in the past six months
• Ultrasound examination within the past 6 months indicated that either ankle joint had characteristic ultrasound manifestations (double-track sign, and/or hyperechoic aggregates, and/or tophi, and/or bone destruction)
• Those who have had an interval of at least 4 weeks since the most recent acute gout attack
• If the patient is undergoing uric acid-lowering drug treatment, the drug dosage must remain stable for more than 4 weeks. During the study period, the uric acid-lowering drug regimen or dosage will not be adjusted
• For women who have the potential to become pregnant, a pregnancy test must be negative, they must not be in the lactation period, and it must be confirmed that they are receiving contraception approved by the researcher and agree to maintain this contraceptive measure throughout the study process
• Those who were informed of this study and signed the informed consent form

Exclusion Criteria:

• Those who have received intra-articular injections of corticosteroids during an attack within the past three months; Those who have taken colchicine, NSAIDs, glucocorticoids in the past two weeks, or those who need to maintain anti-inflammatory drug treatment for a long time during the follow-up period
• Joint trauma or other types of arthritis
• There is a history of joint prosthesis or joint surgery
• Those who have had acute gout attacks within 4 weeks
• Patients with secondary gout caused by kidney diseases, blood disorders, or taking certain medications, radiotherapy and chemotherapy for tumors, etc
• Those with severe and unstable cardiovascular and cerebrovascular diseases (such as unstable angina pectoris, coronary angiogenesis, cerebral angiogenesis, transient ischemic attack, congestive heart failure, etc.) and other diseases that researchers have determined to be acute and difficult to control

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: Experimental Group	Drug: Urate-lowering therapy (ULT); The treatment with uric acid-lowering drugs remained the same as the standard uric acid-lowering treatment plan at the time of enrollment; Behavioral: Cycling; Participants in the study could use the cycling equipment at the fitness center for exercise or do cycling outdoors, but both needed to reach a moderate intensity. Each total exercise session lasts between 45 and 60 minutes (including 5 to 10 minutes of warm-up time, no less than 20 minutes of exercise time reaching 65% to 75% of the maximum heart rate, and 10 to 15 minutes of cool-down exercise/muscle stretching time).
Active Comparator: Control Group	Drug: Urate-lowering therapy (ULT); The treatment with uric acid-lowering drugs remained the same as the standard uric acid-lowering treatment plan at the time of enrollment; Behavioral: Jogging; Participants in the study could exercise on the treadmills in the fitness center or jog outdoors, but both needed to reach a moderate intensity. Each total exercise session lasts between 45 and 60 minutes (including 5 to 10 minutes of warm-up time, no less than 20 minutes of exercise time reaching 65% to 75% of the maximum heart rate, and 10 to 15 minutes of cool-down exercise/muscle stretching time).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The frequency of gout attacks	From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
blood uric acid	From enrollment to the end of treatment at 24 weeks
Gouty arthritis joint pain score	From enrollment to the end of treatment at 24 weeks
Ankle joint magnetic resonance	From enrollment to the end of treatment at 24 weeks
Ankle joint ultrasound	From enrollment to the end of treatment at 24 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events/serious adverse events	From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

• Sponsor: Zhu Xiaoxia

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 14, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Gout; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Nutritional and Metabolic Diseases; Arthritis, Gouty; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Locomotion; Running; Jogging
• Other Study ID Numbers: KY2025-872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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