NCT06852872

Brief Summary

To evaluate the effectiveness of the Isolated Back Extension (ILEX) machine Myosom and examine the influence of preheating on resistance training, the investigators will recruit a cohort of 14 healthy individuals, including both male and female participants, who have no prior experience with ILEX training, for a 9-week training program consisting of a total of 18 sessions. Baseline (BL) measurements will be conducted in the week before the initiation of training, and two follow-up measurements (F/U 1 and F/U 2) carried out after the ninth and eighteenth sessions, with a minimum break of 48 hours after the last training session to ensure proper recovery and to prevent inaccuracies in muscle thickness measurement arising due to acute oedema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

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

Study Start

First participant enrolled

April 29, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

May 7, 2024

Last Update Submit

September 29, 2025

Conditions

Keywords

Isolated lumbar extension traininglumbar muscleThermal Therapy

Outcome Measures

Primary Outcomes (1)

  • maximal isometric force of the back extensors

    measured on the ILEX machine in Newton

    base line, 3 weeks, 6 weeks

Secondary Outcomes (8)

  • isometric back extension endurance

    base line, 3 weeks, 6 weeks

  • Thickness of the Mm. erector spine

    base line, 3 weeks, 6 weeks

  • Lumbar flexibility

    base line, 3 weeks, 6 weeks

  • Lumbar R.O.M.

    base line, 3 weeks, 6 weeks

  • rating of perceived effort

    After each of the 12 training sessions, twice a week for 6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Capacitive Resistive Electric Transfer (CRET) therapy AND Isolate Lumbar Extension (ILEX) Training.

Other: CRET TherapyOther: ILEX training

Sham Group

SHAM COMPARATOR

Sham Capacitive Resistive Electric Transfer (CRET) therapy AND Isolate Lumbar Extension (ILEX) Training.

Other: ILEX trainingOther: CRET therapy sham

Interventions

Diathermy therapy with a protocol to preheat the back extensor muscle

Also known as: TECAR therapy, Diathermy therapy
Intervention group

Isolated lumbar Extension Training

Intervention groupSham Group

Diathermy therapy withouth any radiofrequency as a sham intervention

Also known as: TECAR therapy, Diathermy therapy
Sham Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • pain-free
  • sufficient understanding of the German language
  • able to give informed consent
  • between 18 and 30

You may not qualify if:

  • pregnant
  • medication
  • surgery of lumbar spine
  • knee or hip disorders
  • low back pain
  • pathologies or deformities of lumbar spine
  • other disorders
  • previous or current ILEX Training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Applied Sciences and Arts of Southern Switzerland

Landquart, Kanton Graubünden, 7302, Switzerland

Location

Study Officials

  • Ron Clijsen, PhD

    University of Applied Sciences and Arts of Southern Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

May 7, 2024

First Posted

February 28, 2025

Study Start

April 29, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations