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Trial · NCT07901621

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPeak Oxygen Uptake (VO2peak)Week 0 (baseline) and week 13 (post-intervention)
Highest 30-second average oxygen uptake during a maximal treadmill test (Bruce protocol) with breath-by-breath gas analysis (Cortex Metalyzer 3B), in mL/kg/min. First outcome in the pre-specified fixed-sequence testing hierarchy.
PrimaryResting Systolic Blood PressureWeek 0 (baseline) and week 13 (post-intervention)Automatic upper-arm monitor (OMRON HBP-1120-BR); three readings at 1-minute intervals after 5 minutes of seated rest; mean of the last two readings, in mmHg. Second in the testing hierarchy.
PrimaryResting Diastolic Blood PressureWeek 0 (baseline) and week 13 (post-intervention)Same procedure as systolic blood pressure, in mmHg. Third, in the testing hierarchy.
PrimaryPhysical Health-Related Quality of Life (KDQOL-SF v1.3 Physical Component Summary)Week 0 (baseline) and week 13 (post-intervention)
Physical Component Summary (PCS) of the SF-36 core of the Kidney Disease Quality of Life Short Form (KDQOL-SF v1.3, Brazilian version), reported as a single summary score on a norm-based T-score scale (general population mean 50, SD 10); higher scores indicate better physical health. Fourth in the testing hierarchy.
PrimaryEstimated Glomerular Filtration Rate (eGFR)Week 0 (baseline) and week 13 (post-intervention)eGFR by the race-free CKD-EPI 2021 creatinine-cystatin C equation, from fasting blood samples, in mL/min/1.73 m2. Fifth in the testing hierarchy.
SecondaryBalance (Mini-BESTest)Week 0 (baseline) and week 13 (post-intervention)Mini-Balance Evaluation Systems Test total score (0-28; higher = better balance), Brazilian Portuguese version.
SecondaryFallsDuring the 12-week interventionNumber of participants with at least one fall and fall incidence per group, recorded prospectively with monthly falls calendars (fall defined per ProFaNE consensus).
SecondaryAgility and Dynamic Balance (8-Foot Up and Go Test)Week 0 (baseline) and week 13 (post-intervention)8-Foot Up and Go test; best time of two valid attempts, in seconds.
SecondaryHandgrip StrengthWeek 0 (baseline) and week 13 (post-intervention)Jamar dynamometer, dominant hand, best of three attempts, in kgf.
SecondaryLower-Limb Muscle Strength (30-Second Chair Stand Test)Week 0 (baseline) and week 13 (post-intervention)30-second chair stand test, number of repetitions.
SecondaryMental Health-Related Quality of Life (KDQOL-SF v1.3 Mental Component Summary)Week 0 (baseline) and week 13 (post-intervention)
Mental Component Summary (MCS) of the SF-36 core of the KDQOL-SF v1.3, reported as a single summary score on a norm-based T-score scale (general population mean 50, SD 10); higher scores indicate better mental health.
SecondaryOther KDQOL-SF v1.3 DimensionsWeek 0 (baseline) and week 13 (post-intervention)Scores (0-100) of the remaining generic and kidney disease-specific dimensions; higher scores indicate better quality of life.
SecondaryUremic Toxins and Kidney MarkersWeek 0 (baseline) and week 13 (post-intervention)Serum urea, creatinine, and cystatin C; urinary albumin and protein (first-morning urine).
SecondaryFasting Plasma GlucoseWeek 0 (baseline) and week 13 (post-intervention)Fasting plasma glucose, in mg/dL.
SecondaryGlycated Hemoglobin (HbA1c)Week 0 (baseline) and week 13 (post-intervention)Glycated hemoglobin (HbA1c), in %.
SecondaryLipid ProfileWeek 0 (baseline) and week 13 (post-intervention)Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides (mg/dL).
SecondaryApolipoproteinsWeek 0 (baseline) and week 13 (post-intervention)Apolipoprotein A-I and apolipoprotein B, as cardiovascular risk markers.
SecondaryInflammatory MarkersWeek 0 (baseline) and week 13 (post-intervention)Interleukin-6, interleukin-10, tumor necrosis factor-alpha, and high-sensitivity C-reactive protein.
SecondaryVitamin D StatusWeek 0 (baseline) and week 13 (post-intervention)Serum 25-hydroxyvitamin D.
SecondaryLean MassWeek 0 (baseline) and week 13 (post-intervention)Whole-body lean mass assessed by dual-energy X-ray absorptiometry (DXA), in kg.Lean mass, fat mass, and body fat percentage (whole-body DXA).

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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