The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
NCT07915167, Not applicable, Enrolling by invitation, The Jerzy Kukuczka Academy of Physical Education in Katowice
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients | ClinicalTrials.gov |
| NCT number | NCT07915167 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | The Jerzy Kukuczka Academy of Physical Education in Katowice | ClinicalTrials.gov |
| Conditions | Low Back Pain (LBP), Fascial Manipulation, Hydration, Mobility Decline, Jumping Performance, Bioimpedance Measurement Capacity, Fascia | ClinicalTrials.gov |
| Interventions | hydration, Stecco's Fascial Manipulation therapy, Stecco Fascial Manipulation Therapy + Hydration, Simulated non-interventional soft-tissue therapy | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Pain intensity was assessed using a Visual Analogue Scale (VAS), consisting of a 100-mm horizontal line anchored by two endpoints: 0 mm, indicating "no pain," and 100 mm, indicating "worst pain imaginable. The distance from the zero point to the participant's mark was measured in millimetres, with higher scores indicating greater pain intensity. | ClinicalTrials.gov |
| Primary | Oswestry Questionnaire | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Disability related to low back pain was assessed using the Oswestry Disability Index, version 2.1a (ODI 2.1a). The questionnaire consists of 10 sections assessing pain intensity and the impact of low back pain on activities of daily living, including personal care, lifting, walking, sitting, standing, sleeping, social life, and travelling. Each section is scored from 0 to 5, with higher scores indicating greater disability. The scores from all completed sections are summed and expressed as a percentage of the maximum possible score, ranging from 0% to 100%. Higher ODI scores indicate a greater level of disability associated with low back pain. | ClinicalTrials.gov |
| Primary | Hydration | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Water intake was assessed using an individual water intake questionnaire provided to each participant at the beginning of the study. Participants were instructed to record the amount of water consumed, expressed in millilitres (mL), at specified time points throughout the study period. Each participant was required to complete the questionnaire on an ongoing basis and record their water intake at the designated times. Upon completion of the study, the questionnaires were collected from all participants, and the recorded values were reviewed and summarized to determine the total water intake and the pattern of water consumption during the study period. | ClinicalTrials.gov |
| Primary | Vertical jump | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Vertical jump performance was assessed using the Squat Jump (SJ) test with the Chronojump measurement system. Jump height was recorded using the Chronojump system based on the measured flight time and is specified in centimeters \[cm\]. The obtained results were recorded for each participant and subsequently analyzed to assess lower-limb explosive performance. | ClinicalTrials.gov |
| Primary | Armstrong's Urine Colour Chart | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Hydration status was additionally assessed using Armstrong's Urine Colour Chart. Participants were instructed to compare the colour of their urine with the standardized colour scale provided by the chart and to record the corresponding score. The chart consists of eight colour categories ranging from very pale yellow to dark brown, with lower scores indicating lighter urine colour and better hydration status, while higher scores indicate darker urine colour and a greater likelihood of dehydration. | ClinicalTrials.gov |
| Primary | Urine assessment using diagnostic test strips | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Urine parameters were assessed using commercially available urine diagnostic test strips. Urine samples were collected from each participant at the designated time points during the study period. The test strip was immersed in the urine sample according to the manufacturer's instructions and subsequently evaluated after the specified reaction time. The obtained results were used to assess selected urine parameters related to hydration status, including urine specific gravity and other relevant biochemical indicators. | ClinicalTrials.gov |
| Primary | Water and Fluid Intake Habits Questionnaire (NAS) | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | The questionnaire was administered prior to the commencement of any intervention in order to characterize participants' baseline hydration-related habits and usual fluid consumption. The questionnaire included questions regarding the usual amount and frequency of fluid intake, the types of beverages consumed, and participants' subjective hydration-related habits and symptoms potentially associated with insufficient fluid intake. | ClinicalTrials.gov |
| Primary | Muscle Tone | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Soft tissue properties were assessed using the MyotonPRO device examined F - Natural Oscillation Frequency \[Hz\], characterizing Tone or Tension at the points specified earlier in the study description. | ClinicalTrials.gov |
| Primary | Stiffness | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Soft tissue biomechanics properties were assessed using the MyotonPRO device examined S - Dynamic Stiffness \[N/m\] at the points specified earlier in the study description. | ClinicalTrials.gov |
| Primary | Relaxation | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Soft tissue viscoelastic properties were assessed using the MyotonPRO device examined R - Mechanical Stress Relaxation Time \[ms\] at the points specified earlier in the study description. | ClinicalTrials.gov |
| Primary | BMI | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | To calculate BMI, need parameters such as height in centimeters \[cm\] and body weight in kilograms \[kg\] | ClinicalTrials.gov |
| Primary | Physical activity | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Determining the level of overall weekly physical activity using the PAL (Physical Activity Level) coefficient. * Extremely inactive / Bed Rest: \< 1.2 - 1.4 (Confined to bed, minimal movement) * Sedentary: 1.40 - 1.69 (Seated work, office jobs, little or no strenuous leisure, \~7,500 steps/day) * Moderately Active: 1.70 - 1.99 (Standing/walking work, or seated work plus \~1 hour of daily exercise like running/brisk walking) * Vigorously / Heavily Active: 2.00 - 2.40 (Heavy physical/agricultural labor, construction, or 2+ hours of intense daily training) * Extremely Active: \> 2.40 (Competitive endurance athletes, heavy double-daily training regimens | ClinicalTrials.gov |
| Primary | Total water content (TBW) | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Hydration status was assessed using bioelectrical impedance analysis (BIA). Total body water is calculated and expressed in liters \[L\] and as a percentage \[%\] of body mass. | ClinicalTrials.gov |
| Primary | Intracellular water (ICW) | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Hydration status was assessed using bioelectrical impedance analysis (BIA). Distribution of water into intracellular and extracellular compartments, in liters \[L\] or kilograms \[kg\] | ClinicalTrials.gov |
| Primary | Extracellular water (ECW) | From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks) | Hydration status was assessed using bioelectrical impedance analysis (BIA). Distribution of water into intracellular and extracellular compartments, in liters \[L\] or kilograms \[kg\] | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
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Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
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Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)