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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZhu Xiaoxia

About this trial

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;

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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).

  • 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).

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 2 interventions
Group B: Experimental GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The frequency of gout attacks

Time frame
From enrollment to the end of treatment at 24 weeks

Secondary outcomes

1

blood uric acid

Time frame
From enrollment to the end of treatment at 24 weeks
2

Gouty arthritis joint pain score

Time frame
From enrollment to the end of treatment at 24 weeks
3

Ankle joint magnetic resonance

Time frame
From enrollment to the end of treatment at 24 weeks
4

Ankle joint ultrasound

Time frame
From enrollment to the end of treatment at 24 weeks

Other outcomes

1

Incidence and severity of adverse events/serious adverse events

Time frame
From enrollment to the end of treatment at 24 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhu Xiaoxia

Lead sponsor

Huashan Hospital

Sponsor institution

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