Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000060448
Ethics application status
Approved
Date submitted
1/11/2024
Date registered
21/01/2025
Date last updated
21/01/2025
Date data sharing statement initially provided
21/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in water intake and their impact on soft tissues viscoelastic properties in adults
Scientific title
Assessment of viscoelastic properties of the soft tissues in the context of water intake in adults
Secondary ID [1] 313293 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Water intake 335629 0
Viscoelastic properties of soft tissues 335630 0
Hydration 335889 0
Condition category
Condition code
Musculoskeletal 332188 332188 0 0
Normal musculoskeletal and cartilage development and function
Musculoskeletal 332189 332189 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 332190 332190 0 0
Physiotherapy
Public Health 332191 332191 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Measurement of viscoelastic properties of selected points on the body by device MyotonPro
(points were selected from the Stecco Fascial Manipulation method where each segment has 6 cc points. We examine 3 segments:
for the lumbar section: An - rectus abdominis, Re - erector spinae, Ir - oblique abdominal muscles, Er - oblique abdominal muscles, Me - linea alba, La - quadratus lumborum,
for the hip - An - rectus femoris at the initial insertion, Re - point on the gluteus muscle, Ir - adductor magnus, Er - piriformis, Me - proximal 1/3 of the gracilis muscle, La - tensor fascia lata,
for the knee - An - quadriceps femoris at mid-length, Re - groove between the short and long biceps femoris, Ir - vastus medialis head, Er - biceps femoris, Me - distal 1/3 of the gracilis muscle, La - tensor fascia lata
2.Completion of the questionnaire by the subjects about water intake and daily activities and any contraindications
3.Group assignment
4.Creation of an experimental group increasing water consumption 3 liters a day everyday about 250ml every hour
5.Intervention time is 20 days
6.All participants were required to complete a daily water consumption diary
7.Second testing by device MyotonPro of viscoelastic properties of selected points on the body after 3 weeks of intervention

The MyotonPro tool is used for non-invasive objective assessment of mechanical parameters of soft tissues. It causes mechanical deformation of soft tissues and records parameters such as tension state, tissue viscoelasticity and biomechanical properties. The tool records different viscoelasticity parameters, which describe the viscoelastic properties of soft tissues. It will be used twice before assignment to groups and again 3 weeks after the end of the intervention. Participants will be required to maintain daily activities at the same level and refrain from any changes or greater physical exertion. Group assignment means assignment to one of two groups - control or research.
Intervention code [1] 329868 0
Rehabilitation
Intervention code [2] 329869 0
Lifestyle
Comparator / control treatment
The control group maintained their current water intake as determined in the completed questionnaire at the beginning of the intervention.
Control group
Dose comparison

Outcomes
Primary outcome [1] 339774 0
Water intake
Assessment method [1] 339774 0
Questionnaire created for research purposes
Timepoint [1] 339774 0
At the beginning of the study, assessment of water consumption by a questionnaire, then control of consumption for 3 weeks in the form of a water consumption diary, then after 3 weeks of intervention at the end, assessment of water consumption by a questionnaire
Primary outcome [2] 339775 0
Viscoelastic properties - we records five parameters: frequency (Hz), dynamic stiffness (N/m), elasticity, relaxation time (ms), and creep - the deformation-to-relaxation time ratio (also known as the Deborah number) This will be assessed as a composite outcome
Assessment method [2] 339775 0
MyotonPro - This tool induces mechanical deformation of soft tissues and records parameters such as tension state, viscoelasticity, and biomechanical properties
Timepoint [2] 339775 0
First measurement of all selected points, then another measurement after 3 weeks intervention when participant finish the intervention.
Secondary outcome [1] 441268 0
Nil
Assessment method [1] 441268 0
Nil
Timepoint [1] 441268 0
Nil

Eligibility
Key inclusion criteria
•Age 18-50 years
• Consent to participate in the study
• No health contraindications
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Quarantine or ongoing infection with elevated body temperature
2. Use of spasmolytic medications
3. Lumbar surgical procedure within 6 months prior to the study
4. Health contraindications for participation in the study
5. Engaging in intense physical activity
6. Gastrointestinal disorders involving internal organs
7. Metabolic disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
1/11/2024
Date of last participant enrolment
Anticipated
Actual
1/11/2024
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
57
Final
Recruitment outside Australia
Country [1] 26666 0
Poland
State/province [1] 26666 0

Funding & Sponsors
Funding source category [1] 317744 0
Self funded/Unfunded
Name [1] 317744 0
Country [1] 317744 0
Primary sponsor type
Individual
Name
Kacper Chojowski - Physical Education Academy in Katowice
Country
Poland
Secondary sponsor category [1] 320061 0
None
Name [1] 320061 0
Country [1] 320061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316431 0
Ethics Committee of the National Chamber of Physiotherapists
Ethics committee address [1] 316431 0
Ethics committee country [1] 316431 0
Poland
Date submitted for ethics approval [1] 316431 0
Approval date [1] 316431 0
01/02/2022
Ethics approval number [1] 316431 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 137874 0
Mr Kacper Chojowski
Address 137874 0
Jerzy Kukuczka Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 137874 0
Poland
Phone 137874 0
+48 608 417 253
Email 137874 0
fizjotopic@gmail.com
Contact person for public queries
Name 137875 0
Kacper Chojowski
Address 137875 0
Jerzy Kukuczka Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 137875 0
Poland
Phone 137875 0
+48 608 417 253
Email 137875 0
fizjotopic@gmail.com
Contact person for scientific queries
Name 137876 0
Kacper Chojowski
Address 137876 0
Jerzy Kukuczka Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 137876 0
Poland
Phone 137876 0
+48 608 417 253
Email 137876 0
fizjotopic@gmail.com

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Respondents were informed that we will not share data with other organisations and we want to be honest with them.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.