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

NCT ID: NCT07312396

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-30

Brief Summary

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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;

Detailed Description

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Conditions

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Gout Arthritis Cycling Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

Group Type ACTIVE_COMPARATOR

Urate-lowering therapy (ULT)

Intervention Type DRUG

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

Jogging

Intervention Type 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).

Experimental Group

Group Type EXPERIMENTAL

Urate-lowering therapy (ULT)

Intervention Type DRUG

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

Cycling

Intervention Type 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).

Interventions

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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

Intervention Type DRUG

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).

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhu Xiaoxia

OTHER

Sponsor Role lead

Responsible Party

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Zhu Xiaoxia

Associate Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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KY2025-872

Identifier Type: -

Identifier Source: org_study_id