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New treatment option for Knee Osteoarthristis
Official title The NTU JO-SMART Study
ClinicalTrials.gov ID: NCT07317310
What this study is testing
- What it's testing
- This study recruits patients with coexisting obesity and knee osteoarthritis (KOA) to implement the NTU-JO Smart Program, an innovative intervention integrating AI-assisted community-based exercise with continuous glucose monitoring (CGM). The primary objective is to investigate whether this intervention can improve glycemic control in this comorbid population.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age: 18 to 75 years.
- Obesity status: body mass index (BMI) ≥ 27 kg/m², consistent with the obesity definition defined by the Health Promotion Administration, Ministry of...
- Diagnosis of KOA in at least one knee according to the American College of Rheumatology (ACR) criteria, with a Kellgren-Lawrence (KL) grade of 1, 2...
- Symptomatic disease: defined as a WOMAC pain subscale score (range 0-20) greater than 4 at screening.
- Sedentary lifestyle: defined as less than 30 minutes of physical activity per week for the past 6 months.
You likely can't join if
- KL grade 4 KOA in either knee.
- Diagnosis of inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.
- Knee arthroscopy within the past 3 months or previous surgical history of TKA.
- Recent receipt of intra-articular injections (e.g., corticosteroids, hyaluronic acid) within the past 3 months.
- Documented history of osteoporotic fracture in hospital or cloud-based medical records.
- Type 1 diabetes.
See the full eligibility criteria
- Age: 18 to 75 years.
- Obesity status: body mass index (BMI) ≥ 27 kg/m², consistent with the obesity definition defined by the Health Promotion Administration, Ministry of Health and Welfare, Taiwan.
- Diagnosis of KOA in at least one knee according to the American College of Rheumatology (ACR) criteria, with a Kellgren-Lawrence (KL) grade of 1, 2, or 3.
- Symptomatic disease: defined as a WOMAC pain subscale score (range 0-20) greater than 4 at screening.
- Sedentary lifestyle: defined as less than 30 minutes of physical activity per week for the past 6 months.
- Informed consent: willing and able to provide written informed consent and comply with all longitudinal study procedures.
- Comorbid status: participants may be included regardless of a baseline diagnosis of T2D or CKD. Stratified randomization and subgroup analyses will be conducted based on these baseline conditions.
- KL grade 4 KOA in either knee.
- Diagnosis of inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.
- Knee arthroscopy within the past 3 months or previous surgical history of TKA.
- Recent receipt of intra-articular injections (e.g., corticosteroids, hyaluronic acid) within the past 3 months.
- Documented history of osteoporotic fracture in hospital or cloud-based medical records.
- Type 1 diabetes.
- Presence of conditions precluding safe participation in an exercise program, such as unstable cardiovascular disease or severe neurological disorders.
- Participation in another treatment clinical trial within the past 3 months.
- Engagement in dietary regimens likely to cause significant weight change (e.g., intermittent fasting, such as the 16:8 time-restricted eating) within 1 month prior to trial initiation.
- Use of any FDA-approved weight-loss medications (e.g., semaglutide, tirzepatide) within 3 months prior to trial initiation.
- History of any form of surgical treatment for weight loss.
- Current use of lithium or antipsychotics at a dose equivalent to olanzapine \>20 mg/day.
- Pregnant or breastfeeding women, or women of childbearing potential without adequate contraception.
- Current malignancy (within the validity period of a catastrophic illness certificate), or any other clinical condition deemed unsuitable for participation by the investigator (investigator discretion).
- Inability to use smart devices or telecommunication tools due to severe visual/hearing impairment or lack of internet access.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan, Taiwan
- Yunlin, Taiwan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan, Taiwan; Yunlin, Taiwan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.