Trial · NCT07065591
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain by visual analogue scale | At 0,1.5, 3, 6 and 12 months | Measure the change in pain level through visual analogue scale (VAS) (0-100mm) |
| Secondary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | At 0,1.5, 3, 6 and 12 months | Western Ontario and McMaster Universities Arthritis Index (WOMAC) consists of 24 items divided into 3 subscales Pain (5 items), Stiffness (2 items)Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score. |
| Secondary | Body weight | At 0,1.5, 3, 6 and 12 months | Body weight (kg - kilogram) will be measured at each visit. |
| Secondary | Knee stiffness | At 0,1.5, 3, 6 and 12 months | It is measured by knee range measurement |
| Secondary | Physical Activity through questionnaire | At 0,1.5, 3, 6 and 12 months | It is measured by the International Physical Activity Questionnaire short version. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). |
| Secondary | Willingness to proceed TKR immediately | At 0,1.5, 3, 6 and 12 months | It is measured as proxy of need of TKR. |
| Secondary | Physical performance of the muscle - walk | At 0,1.5, 3, 6 and 12 months | It is measured by 6-metre walk: time to walk 6 metres without deceleration is taken (average of 2 trials is taken, cut-off \<1.0m/s). |
| Secondary | Physical performance of the muscle - chair stand | At 0,1.5, 3, 6 and 12 months | It is measured by 5-time chair stand test: time to rise from chair 5 times is recorded (cut-off≥12 seconds). |
| Secondary | Physical performance of the muscle - balance | At 0,1.5, 3, 6 and 12 months | It is measured by Short Physical Performance Battery (SPPB, cut-off\<=9). Patients will perform the balance test first, followed by the gait speed test, and finally the chair stand test. Each test will be scored individually, and the total score will be calculated by summing the scores of all three tests. The overall score ranges from 0 to 12, with 12 indicating the best performance. |
| Secondary | Muscle strength - Handgrip strength | At 0,1.5, 3, 6 and 12 months | It is measured by spring-type handgrip dynamometer (JAMAR Hand Dynamometer) with dominant hand in a maximum-effort isometric contraction (cut-off=M: \<28 kg, F: \<18 kg) |
| Secondary | Appendicular skeletal muscle mass (ASM) | At 0,1.5, 3, 6 and 12 months | It is measured by Bioelectrical impedance analysis (TANITA DC430MA (Tokyo, Japan) with a precision of 0.05 kg. with cut-off=M: \<7.0 kg/m2, F: \<5.7 kg/m2) |
| Secondary | Patient-reported outcome measure questionnaire | At 0,1.5, 3, 6 and 12 months | It is measured by Sarcopenia and Quality of Life (SarQoL). The final version of the SarQoL® is composed of 55 items translated into 22 questions rated on a 4-point Likert scale. The questionnaire is scored on 100 points. Higher score reflects a higher quality of life. |
| Secondary | Kellgren-Lawrence grade | At 0, 6, 12 months | It is measured at the X-ray, with grade 1, 2, 3 and 4. |
| Secondary | Compliance to the study | At every month, up to 1 year | It is a monthly phone/clinic follow-up to assess pill count for adherence |
| Secondary | Blood glucose test. | At baseline, 6 and 12 months | All patients will be received blood glucose test at baseline for fitness, 6months and 12 months, measured in mmol/L. |
| Secondary | Blood test - Complete blood count | At baseline, 6 and 12 months | Complete blood count in thousand cells per microliter (K/μL). |
| Secondary | Blood test - Liver function test | At baseline, 6 and 12 months | Liver/renal function test, level of alanine transaminase (ALT) and aspartate transaminase (AST). |
| Secondary | Blood test - renal function test | At baseline, 6 and 12 months | Renal function test in Estimated Glomerular Filtration Rate (eGFR). |
| Secondary | Blood test - Vitamin B12 | At baseline, 6 and 12 months | Vitamin B12 in Picograms per milliliter (pg/mL). |
| Secondary | Blood test - Calcium phosphate | At baseline, 6 and 12 months | Calcium phosphate in millimoles per liter (mmol/L). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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