NCT06082752

Brief Summary

The study design was a randomised, controlled, parallel, two-arm trial. The subjects were randomly assigned to one of the study groups: the intervention group or the control group. The passive mechanical properties, i.e. the stiffness and tone of the medial and lateral gastrocnemius muscle (dominant leg) were assessed. Measures were taken twice: in the intervention group before and after the 5-minute massage session, and in the control group at the beginning of the meeting and again after 5 minutes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

16 days

First QC Date

October 7, 2023

Last Update Submit

November 6, 2023

Conditions

Keywords

Massage therapyMuscle toneMuscle stiffness

Outcome Measures

Primary Outcomes (10)

  • Changes in maximal displacement of the medial and lateral gastrocnemius muscle

    The maximal radial displacement is produced in the muscle belly after the electrical stimulation. Measuring device: TMG S2

    1) baseline, 2) immediately after the massage session

  • Changes in delay time of the medial and lateral gastrocnemius muscle

    Delay time is the time in which the muscle displacement increases to 10% after the electrical stimulation. Measuring device: TMG S2

    1) baseline, 2) immediately after the massage session

  • Changes in contraction time of the medial and lateral gastrocnemius muscle

    Contraction time is the time between 10% and 90% of the muscle displacement after the electrical stimulation. Measuring device: TMG S2

    1) baseline, 2) immediately after the massage session

  • Changes in sustain time of the medial and lateral gastrocnemius muscle

    Sustain time is the time between 50% of maximum contraction to 50% of maximum relaxation of a muscle after the electrical stimulation. Measuring device: TMG S2

    1) baseline, 2) immediately after the massage session

  • Changes in relaxation time of the medial and lateral gastrocnemius muscle

    Relaxation time is the time between 90% of maximum contraction and 50% of maximum relaxation of a muscle after the electrical stimulation. Measuring device: TMG S2

    1) baseline, 2) immediately after the massage session

  • Changes in oscillation frequency of the medial and lateral gastrocnemius muscle

    The oscillation frequency characterizes the tension of muscle tissue. Measuring device: MyotonPRO

    1) baseline, 2) immediately after the massage session

  • Changes in dynamic stiffness of the medial and lateral gastrocnemius muscle

    The dynamic stiffness corresponds to the soft tissues' capacity to resist external forces. Measuring device: MyotonPRO

    1) baseline, 2) immediately after the massage session

  • Changes in logarithmic decrement of the medial and lateral gastrocnemius muscle

    Logarithmic decrement is the dissipation of the tissue oscillation. Measuring device: MyotonPRO

    1) baseline, 2) immediately after the massage session

  • Changes in mechanical stress relaxation time of the medial and lateral gastrocnemius muscle

    Mechanical stress relaxation time is the time needed for the muscle to recover to its initial shape. Measuring device: MyotonPRO

    1) baseline, 2) immediately after the massage session

  • Changes in creep of the medial and lateral gastrocnemius muscle

    Creep is the ratio of relaxation (R) and time between the beginning of the mechanical impulse and the time point of maximal displacement Measuring device: MyotonPRO

    1) baseline, 2) immediately after the massage session

Study Arms (2)

Massage group

EXPERIMENTAL

In the intervention group measures will be taken twice: before and after the 5-minute massage session.

Procedure: Massage session

Non-massage group

NO INTERVENTION

In the control group measures will be taken twice: at the beginning of the meeting and again after 5 minutes.

Interventions

Participants in the intervention group are provided with the 5-minute massage session in the medial and lateral gastrocnemius muscle (dominant leg).

Massage group

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 19 and 24 years;
  • healthy individuals, with no lower limb pathology;
  • PA≥600 MET-min/week assessed by IPAQ questionnaire;
  • no medical contraindication of massage therapy;
  • body mass index 18,5 \< BMI ≤ 25kg/m2
  • signing the informed consent.

You may not qualify if:

  • pregnant women;
  • individuals suffering from neurologic or orthopaedic problems;
  • lower limb surgical interventions;
  • cancers;
  • musculoskeletal disorders
  • body mass index 18,5 \> BMI ≥ 25kg/m2
  • the lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw University of Health and Sport Sciences

Wroclaw, Poland

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Krzysztof Kassolik

    Wroclaw University of Health and Sport Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2023

First Posted

October 13, 2023

Study Start

October 20, 2023

Primary Completion

November 5, 2023

Study Completion

November 6, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations