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Trial · NCT07891936

Registered outcomes67

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

ListOutcomeTime frameDescription
PrimaryMuscle QualityFrom enrollment to the end of treatment at 32 weeks
It is defined as the capacity of skeletal muscle to generate strength relative to its mass, integrating both structural and functional aspects. It will be expressed as the ratio between the estimated 1-RM strength and muscle mass measured by dual-energy X-ray absorptiometry (DEXA)
SecondaryNutritional profileFrom enrollment to the end of treatment at 32 weeks
This will be assessed through a nutritional interview conducted by a professional, which will include a complete dietary history, a 24-hour dietary recall (24hR), and a food frequency questionnaire (FFQ)
SecondaryBody compositionFrom enrollment to the end of treatment at 32 weeksassessed through basic anthropometry: weight in kilogram (kg)
SecondaryBody compositionFrom enrollment to the end of treatment at 32 weeksassessed through basic anthropometry: height in centimeter (cm)
SecondaryBody compositionFrom enrollment to the end of treatment at 32 weeksassessed through basic anthropometry: body mass index (BMI), weight and height will be combined to report BMI in kg/m\^2
SecondaryBody compositionFrom enrollment to the end of treatment at 32 weeksDual X-Ray Densitometry: body adiposity index, (BAI) in perctange (%)
SecondaryBody compositionFrom enrollment to the end of treatment at 32 weeksDual X-Ray Densitometry: fat mass index (FMI) kilograms per square meter. kg/m²
SecondaryBody compositionFrom enrollment to the end of treatment at 32 weeksDual X-Ray Densitometry: visceral adipose tissue area, VAT Area in square centimeter (cm²)
SecondaryBody compositionFrom enrollment to the end of treatment at 32 weeksDual X-Ray Densitometry: skeletal muscle mass index, (SMI) kilograms per square meter. kg/m²
SecondaryBody compositionFrom enrollment to the end of treatment at 32 weeksDual X-Ray Densitometry: appendicular skeletal muscle mass index, (ASM). kilograms per square meter. kg/m²
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): VO2 max (L/min) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Relative VO2 (ml/kg/min) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Absolute VO2 (L/min) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Absolute VCO2 (L/min) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Respiratory exchange ratio, RER in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Ventilatory equivalent, rate of ventilation and absolute O2 (VE/O2) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Ventilatory equivalent, rate of ventilation and absolute CO2 (VE/CO2) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
(1) Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Speed (km/h) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks
(1) Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): time in sencond (s) when it appears First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
SecondaryPhysical fitnessFrom enrollment to the end of treatment at 32 weeks(1) Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): V-Slope break-point (%)

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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