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

NCT07312396 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-872
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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;

Conditions

Gout Arthritis; Cycling; Physical Activity

Outcome Measures

Primary Outcomes (1)

• The frequency of gout attacks

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (4)

• 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 Outcomes (1)

• Incidence and severity of adverse events/serious adverse events

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Drug: Urate-lowering therapy (ULT); Behavioral: Jogging

Experimental Group

EXPERIMENTAL

Drug: Urate-lowering therapy (ULT); Behavioral: Cycling

Interventions

Urate-lowering therapy (ULT) DRUG

The treatment with uric acid-lowering drugs remained the same as the standard uric acid-lowering treatment plan at the time of enrollment

Control Group; Experimental Group

Jogging BEHAVIORAL

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).

Control Group

Cycling BEHAVIORAL

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).

Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhu Xiaoxia: lead

MeSH Terms

Conditions

Arthritis, Gouty; Motor Activity

Interventions

Jogging

Condition Hierarchy (Ancestors)

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Running; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share