The Effect of Diathermy Therapy on Isolated Lumbar Extension (ILEX) Training
ILEX
1 other identifier
interventional
25
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
May 7, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2025
CompletedOctober 3, 2025
September 1, 2025
12 months
May 7, 2024
September 29, 2025
Conditions
Keywords
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
EXPERIMENTALCapacitive Resistive Electric Transfer (CRET) therapy AND Isolate Lumbar Extension (ILEX) Training.
Sham Group
SHAM COMPARATORSham Capacitive Resistive Electric Transfer (CRET) therapy AND Isolate Lumbar Extension (ILEX) Training.
Interventions
Diathermy therapy with a protocol to preheat the back extensor muscle
Diathermy therapy withouth any radiofrequency as a sham intervention
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Clijsen, PhD
University of Applied Sciences and Arts of Southern Switzerland
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
- 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