Trial · NCT07892742
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute and Relative Ankle Plantar-Flexion Peak Force | Day 1 (baseline) and Day 7 (post-intervention) | Absolute peak force (N) and relative peak force (N·kg-¹) during a seated maximal voluntary isometric plantar-flexion contraction of the dominant limb. The highest force value recorded across four trials will be used for analysis. |
| Primary | Rate of Force Development During Isometric Ankle Plantar-Flexion | Day 1 (baseline) and Day 7 (post-intervention) | Rate of force development (RFD; N·s-¹) during maximal voluntary isometric plantar-flexion of the dominant limb, calculated over consecutive 50-ms intervals from contraction onset: 0-50, 50-100, 100-150, and 150-200 ms. |
| Primary | Rate of Force Development During Dynamic Ankle Plantar-Flexion | Day 1 (baseline) and Day 7 (post-intervention) | Rate of force development (N·s-¹) during a standing bilateral rapid calf-raise task, calculated as peak force (N) divided by time to peak force (s). |
| Primary | Explosive Isometric Ankle Plantar-Flexion Force | Day 1 (baseline) and Day 7 (post-intervention) | Explosive force, expressed as the percentage of peak force (%F) attained at 50, 100, 150, and 200 ms following contraction onset during maximal voluntary isometric plantar-flexion of the dominant limb. |
| Primary | Peak Force during the 5 repetition STS | Day 1 (baseline) and Day 7 (post-intervention) | Peak vertical ground reaction force (N) recorded during the concentric phase of each sit-to-stand repetition. The participant-level summary measure will be defined a priori. |
| Primary | Fatigue Index During the 30-Second Sit-to-Stand Test | Day 1 (baseline) and Day 7 (post-intervention) | Fatigue index calculated to quantify the decline in performance across successive sit-to-stand repetitions during the 30-s STS. The calculation method will be specified a priori. |
| Primary | Mean Power During the 30-Second Sit-to-Stand Test | Day 1 (baseline) and Day 7 (post-intervention) | Mean lower-limb muscle power during the 30-s STS, estimated using a previously validated equation. |
| Secondary | Time to Complete the First Five Sit-to-Stand Repetitions | Day 1 (baseline) and Day 7 (post-intervention) | Time (s) required to complete the first five sit-to-stand repetitions during the 30-s STS test, measured from the onset of the first repetition until completion of the fifth repetition. Only participants completing at least five repetitions will be included in this analysis. |
| Secondary | Functional Lower-Limb Performance | Day 1 (baseline) and Day 7 (post-intervention) | Number of completed repetitions during the 30-second sit-to-stand test (30-s STS), performed from a 43-cm armless chair. |
| Secondary | Change in Handgrip strength | Day 1 (baseline) and Day 7 (post-intervention) | Handgrip strength will be assessed using a portable hand dynamometer (Jamar Plus+). Participants will perform three maximal voluntary isometric contractions with each hand alternately. A 60-second rest period will be provided between attempts. The highest recorded value will be used for analysis. The outcome will be expressed as the change in handgrip strength from baseline to the post-intervention assessment. |
| Secondary | Change in Short Physical Performance Battery Score | Day 1 (baseline) and Day 7 (post-intervention) | Functional performance will be assessed using the Short Physical Performance Battery (SPPB), comprising static balance, 4-meter gait speed, and repeated chair stand tests. The SPPB score will be calculated according to the standardized scoring procedure. The outcome will be expressed as the change in SPPB score from baseline to the post-intervention assessment. |
| Secondary | Change in Timed Up and Go Test Performance | Day 1 (baseline) and Day 7 (post-intervention) | The Timed Up and Go (TUG) test will assess functional mobility and fall risk. Participants will stand from a chair, walk 3 meters, turn around a reference point, return to the chair, and sit down. The time required to complete the test will be recorded. The outcome will be expressed as the change in TUG completion time from baseline to the post-intervention assessment. |
| Secondary | Change in Serum Arginine Vasopressin Concentration | Day 1 (baseline) and Day 7 (post-intervention) | Serum arginine vasopressin (AVP), will be assessed as a biomarker of the physiological regulation of water balance. Venous blood samples will be collected in the morning after an overnight fast. Serum AVP concentration will be determined using a radioimmunoassay (RIA) according to the standardized procedures of the clinical laboratory. The outcome will be expressed as the change in serum AVP concentration from baseline to the post-intervention assessment. |
| Secondary | Change in Fasting Serum Glucose Concentration | Day 1 (baseline) and Day 7 (post-intervention) | Fasting serum glucose concentration will be assessed as a biochemical marker of glucose metabolism. Venous blood samples will be collected in the morning following an overnight fast of 8-12 hours. Serum glucose concentration will be determined using the hexokinase-glucose-6-phosphate dehydrogenase enzymatic method according to the standardized procedures of the clinical laboratory. The outcome will be expressed as the change in fasting serum glucose concentration from baseline to the post-intervention assessment. |
| Secondary | Change in Serum Cortisol Concentration | Day 1 (baseline) and Day 7 (post-intervention) | Serum basal cortisol concentration will be assessed as an endocrine biomarker. Venous blood samples will be collected in the morning following an overnight fast, with the time of blood collection recorded to account for the circadian variation in cortisol concentrations. Serum cortisol concentration will be determined using a chemiluminescence assay according to the standardized procedures of the clinical laboratory. The outcome will be expressed as the change in serum cortisol concentration from baseline to the post-intervention assessment. |
| Secondary | Change in Fasting Serum Insulin Concentration | Day 1 (baseline) and Day 7 (post-intervention) | Fasting serum insulin concentration will be assessed as a biochemical marker of insulin metabolism. Venous blood samples will be collected in the morning following an overnight fast of 8-12 hours. Serum insulin concentration will be determined using a chemiluminescence immunoassay according to the standardized procedures of the clinical laboratory. The outcome will be expressed as the change in fasting serum insulin concentration from baseline to the post-intervention assessment. |
| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Day 1 (baseline) and Day 7 (post-intervention) | Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting serum glucose and fasting serum insulin concentrations. HOMA-IR will be calculated as: fasting insulin (μU/mL) × fasting glucose (mmol/L) / 22.5. The outcome will be expressed as the change in HOMA-IR from baseline to the post-intervention assessment. |
| Secondary | Change in serum osmolality | Day 1 (baseline) and Day 7 (post-intervention) | Serum, osmolality (mOsm/kg) will be measured using a freezing-point depression osmometer (Mod OSMO1, Advanced Instruments, Canada). All osmolality measurements will be performed in duplicate. |
| Secondary | Change in saliva osmolality | Day 1 (baseline) and Day 7 (post-intervention) | Saliva osmolality (mOsm/kg) will be measured using a freezing-point depression osmometer (Mod OSMO1, Advanced Instruments, Canada). All osmolality measurements will be performed in duplicate. Unstimulated saliva samples will be collected with participants seated comfortably after resting quietly for 2 min, allowing saliva to accumulate passively in the mouth. Participants will then provide approximately 3-4 mL of saliva into Salivette collection tubes or until no additional saliva can be comfortably produced. |
| Secondary | Change in urine osmolality | Day 1 (baseline) and Day 7 (post-intervention) | Urine osmolality (mOsm/kg) will be measured using a freezing-point depression osmometer (Mod OSMO1, Advanced Instruments, Canada). Urine samples will be collected in sterile urine collection cups at the specified assessment time point. Participants will be instructed to provide a midstream urine sample after discarding the initial urine stream. All osmolality measurements will be performed in duplicate. |
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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