Gout ArthritisNCT07312396
An Exploratory Clinical Study on the Protective Effect of Cycling on the Ankle Joint in Gout
A study testing Urate-lowering therapy (ULT), Jogging and Cycling in people with Gout Arthritis and Cycling, run by Zhu Xiaoxia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gout Arthritis, Cycling, Physical Activity
- What is being tested?
- Urate-lowering therapy (ULT), Jogging and Cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Being tested
- Urate-lowering therapy (ULT), Jogging, Cycling
- Medical subject headings
- Arthritis, Gouty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
JoggingBehavioural
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).
CyclingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Drug: Urate-lowering therapy (ULT); Behavioral: Jogging |
| Experimental Group | Experimental | Not described Receives: Drug: Urate-lowering therapy (ULT); Behavioral: Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of gout attacks
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (4)
blood uric acid
Measured: From enrollment to the end of treatment at 24 weeks
Gouty arthritis joint pain score
Measured: From enrollment to the end of treatment at 24 weeks
Ankle joint magnetic resonance
Measured: From enrollment to the end of treatment at 24 weeks
Ankle joint ultrasound
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Xiaoxia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Xiaoxia, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312396
- Sponsor's protocol ID
- KY2025-872
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Protective Effect of Cycling on the Ankle Joint in Gout
- ClinicalTrials.gov ID
- NCT07312396
- Acronym / sponsor ID
- KY2025-872
- Conditions
- Gout Arthritis, Cycling, Physical Activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhu XiaoxiaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Urate-lowering therapy (ULT), Behavioral: Jogging |
| Experimental Group | Experimental | Drug: Urate-lowering therapy (ULT), Behavioral: Cycling |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Control Group, Experimental Group |
| JoggingParticipants 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). | Behavioural | Control Group |
| CyclingParticipants 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). | Behavioural | Experimental Group |
Primary outcome
The frequency of gout attacks
Time frame: From enrollment to the end of treatment at 24 weeks
4 secondary outcomes
blood uric acid
Time frame: From enrollment to the end of treatment at 24 weeks
Gouty arthritis joint pain score
Time frame: From enrollment to the end of treatment at 24 weeks
Ankle joint magnetic resonance
Time frame: From enrollment to the end of treatment at 24 weeks
Ankle joint ultrasound
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Urate-lowering therapy (ULT), Jogging and Cycling in people with Gout Arthritis and Cycling, run by Zhu Xiaoxia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of gout attacks (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.