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Trial registered on ANZCTR


Registration number
ACTRN12625000120471
Ethics application status
Approved
Date submitted
17/12/2024
Date registered
3/02/2025
Date last updated
3/02/2025
Date data sharing statement initially provided
3/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating small blood molecules (miRNAs) as indicators of musculoskeletal pain in runners
Scientific title
Changes in miRNA expression levels following a 6-week kinesiological intervention: a pre-post study in long-distance runners aged at least 35 years
Secondary ID [1] 313581 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MiMuS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal pain 336112 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332664 332664 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention utilizes a kinesiological approach based on the Canali Postural Method (CPM), designed to prevent, reduce, or eliminate compensatory postural patterns by addressing peripheral muscular imbalances, such as resistance or dominance, that may contribute to musculoskeletal pain.
Participants follow individualized exercise plans tailored to their specific postural needs. These plans, which emphasize postural adjustments and muscular rebalancing without directly targeting painful areas, are introduced during supervised sessions and reviewed weekly to ensure proper execution and adherence.
A CPM-certified operator, trained extensively in CPM techniques, delivers the intervention during one-on-one supervised sessions. The program combines face-to-face supervised sessions with self-managed sessions, allowing participants to practice independently. Exercises are adapted to individual conditions, ensuring pain-free execution or modifications to avoid exacerbating discomfort. The first session also functions as a test phase to identify the origins of compensatory postural patterns and determine appropriate exercises.
The intervention consists of alternating sequences of strengthening (e.g. abdominal muscles strengthening) and stretching exercises (e.g. hamstring muscle stretching), repeated in sets. In subsequent sessions, strengthening exercises are progressively increased in duration and difficulty, adjusted according to each participant's capabilities and feedback.
The 6-week intervention involves three 60-minute sessions per week, scheduled on non-consecutive days to allow sufficient recovery between sessions. Each week, participants attend one supervised session at the Posture and Movement Laboratory (MP-LAB) of the Institute of Clinical Physiology, while the remaining two sessions are self-managed and conducted in their own training environments.Exercise intensity is dynamically managed during supervised sessions by monitoring participants' ability to maintain proper form while avoiding discomfort or excessive fatigue. Adjustments are made progressively to maintain a balance between challenge and individual capacity.Adherence is monitored during the weekly supervised sessions, where exercise execution is assessed, and feedback is provided to ensure participants remain aligned with the intervention protocol.
Intervention code [1] 330176 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340179 0
Change in plasma miRNA expression levels
Timepoint [1] 340179 0
Before the first session and at the end of the 6-week intervention period
Secondary outcome [1] 443180 0
Stress level
Timepoint [1] 443180 0
Before the first session and at the end of the 6-week intervention period
Secondary outcome [2] 443181 0
Level of pain
Timepoint [2] 443181 0
Before the first session and at the end of the 6-week intervention period

Eligibility
Key inclusion criteria
long-distance runners registered with Lecce sections of the Italian Federation of Athletics;
aged at least 35 years;
possession of the medical certificate for competitive sport activity
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
doctor’s indication not to carry out physical activity during the investigation period; presence of chronic diseases; ongoing pregnancy or less than 6 months from the childbirth and less than 6 months from weaning.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Date of first participant enrolment
Anticipated
Actual
30/05/2023
Date of last participant enrolment
Anticipated
Actual
30/09/2023
Date of last data collection
Anticipated
Actual
9/01/2024
Sample size
Target
30
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 26789 0
Italy
State/province [1] 26789 0

Funding & Sponsors
Funding source category [1] 318048 0
Other
Name [1] 318048 0
National Research Council, Institute of Clinical Physiology, Lecce
Country [1] 318048 0
Italy
Primary sponsor type
Other
Name
National Research Council, Institute of Clinical Physiology, Lecce
Address
Country
Italy
Secondary sponsor category [1] 320403 0
University
Name [1] 320403 0
University of Salento
Address [1] 320403 0
Country [1] 320403 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316703 0
Ethical Committee of the Lecce Local Health Authority
Ethics committee address [1] 316703 0
Sede Legale di via Miglietta n. 5 – Lecce
Ethics committee country [1] 316703 0
Italy
Date submitted for ethics approval [1] 316703 0
Approval date [1] 316703 0
02/02/2023
Ethics approval number [1] 316703 0
deliberation n. 0000108

Summary
Brief summary
The purpose of this study is to investigate whether a 6-week kinesiological intervention, based on the Canali Postural Method (CPM), can lead to significant changes in the expression of specific microRNAs (miRNAs) in long-distance runners experiencing musculoskeletal pain. The study hypothesizes that the intervention may influence miRNA levels, which could serve as potential biomarkers to monitor musculoskeletal pain and postural balance improvements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138722 0
Dr Maria Rosaria Tumolo
Address 138722 0
University of Salento, Strada provinciale Lecce-Monteroni, 73100 – Lecce
Country 138722 0
Italy
Phone 138722 0
+393890118275
Fax 138722 0
Email 138722 0
[email protected]
Contact person for public queries
Name 138723 0
Saverio Sabina
Address 138723 0
Institute of Clinical Physiology, Strada provinciale Lecce-Monteroni, 73100 – Lecce
Country 138723 0
Italy
Phone 138723 0
+393283378092
Fax 138723 0
Email 138723 0
[email protected]
Contact person for scientific queries
Name 138724 0
Maria Rosaria Tumolo
Address 138724 0
University of Salento, Strada provinciale Lecce-Monteroni, 73100 – Lecce
Country 138724 0
Italy
Phone 138724 0
+393890118275
Fax 138724 0
Email 138724 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
privacy


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24474Ethical approval    388916-(Uploaded-21-01-2025-01-54-57)-DEL.MICRO RNA.pdf



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.