Resistance TrainingILEXNCT06852872
The Effect of Diathermy Therapy on Isolated Lumbar Extension (ILEX) Training
A study testing CRET Therapy and ILEX training in people with Resistance Training and Healthy Participants Study, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Resistance Training, Healthy Participants Study
- What is being tested?
- CRET Therapy and ILEX training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Apr 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- pain-free
- sufficient understanding of the German language
- able to give informed consent
- between 18 and 30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Applied Sciences and Arts of Southern Switzerland
Landquart, Kanton Graubünden, 7302
About this study
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.
Read the detailed description
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 edema.
At BL, participants will need to give written informed consent and be familiarized to the back extensor machine and Category-Ratio-Scale (CR10) for the assessment of perceived effort and discomfort as well as thermal sensation and thermal comfort. Baseline assessment will include epidemiological data such as age, sex, height, and weight. At all three measurements (BL, F/U 1, F/U 2), the lumbar extensor musculature thickness (M. erector spinae) is evaluated through the ultrasound system Mylab2 (Esaote, Maastricht, Netherlands), the lower back flexibility is examined using a sit-and-reach test, and the isometric back extension endurance is measured through the Biering-Sørrensen test. Finally, maximal range of motion (ROM) and maximal voluntary isometric contraction will be evaluated using the Myosom machine.
Participants will be randomly assigned to either the sham group, which will receive a 10-minute treatment with Tecar device (T-Plus, Wintecare SA, Chiasso, Switzerland) turned off and not sending radiofrequency before each exercise session, or the intervention group, which will undergo a 10-minute treatment with the Tecar device to induce 448kHz capacitive monopolar radiofrequency and facilitate warming up of deep tissues. After every treatment the participants will be asked to rate their thermal sensation and comfort. Skin temperature will be measured using an infrared thermal imaging (FLIR A615 series, Emitec Industrial, Rotkreuz, Switzerland) after the first and final Tecar treatment.
Training will take place twice a week, beginning with a dynamic warm-up of the lumbar extensor for 120s, followed by three sets of resistance training (RT) lasting 120s, 120s, and 150s respectively, and concluding with a final set of dynamic recovery lasting 60s. 30-second recovery will be provided between every set. A low load will be used for the warm-up and recovery. The load will be subsequently increased until volitional fatigue. Repetitions will be executed by taking three seconds from complete flexion to complete extension, ensuring standardization at 20 repetitions per minute. A metronome with 40 beats per minute will provide audible feedback. The Myosom machine emits an audible signal upon completion of each phase of the repetition to guarantee a complete range of motion is achieved. Subsequent to every training session, participants will be requested to provide their effort (RPE-E) and discomfort (RPE-D) values.
- Conditions
- Resistance Training, Healthy Participants Study
- Being tested
- CRET Therapy, ILEX training, CRET therapy sham
- Keywords
- Isolated lumbar extension training, lumbar muscle, Thermal Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRET TherapyOther
Also called TECAR therapy, Diathermy therapy
Diathermy therapy with a protocol to preheat the back extensor muscle
ILEX trainingOther
Isolated lumbar Extension Training
CRET therapy shamOther
Also called TECAR therapy, Diathermy therapy
Diathermy therapy withouth any radiofrequency as a sham intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Capacitive Resistive Electric Transfer (CRET) therapy AND Isolate Lumbar Extension (ILEX) Training. Receives: Other: CRET Therapy; Other: ILEX training |
| Sham Group | Sham comparator | Sham Capacitive Resistive Electric Transfer (CRET) therapy AND Isolate Lumbar Extension (ILEX) Training. Receives: Other: ILEX training; Other: CRET therapy sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Isometric Force of the Back Extensors
Maximum voluntary isometric contraction (MVIC) of the back extensor was measured using the ILEX machine. With arms folded across the chest, participants performed a slow, continuous 2-3 s maximal-effort back extension against the fixed upper-back pad. Peak torque (N) was recorded electronically, and the higher of two trials was used for analysis.
Measured: Baseline, 3 weeks, 6 weeks
Secondary outcomes (8)
Isometric Back Extension Endurance
Back extensor endurance (s) was assessed using the Biering-Sørensen test. Participants lay prone on an examination table with the upper iliac crests aligned with the table edge, and the lower body secured by straps placed around the proximal thighs and calves.With arms folded across the chest, participants held a horizontal upper body in contact with a bar for as long as possible.
Measured: base line, 3 weeks, 6 weeks
Thickness of the Mm. Erector Spine
Muscle thickness (MT) of the M. erector spinae was measured using ultrasound. Participants lay prone on an examination table, and the probe was positioned perpendicular to the muscle on the right side of the lower back, using coupling gel and minimal pressure. The thickness of the longissimus was measured as the distance (mm) from the outermost point of the fascia to the outermost point of the L3 transverse process.
Measured: Baseline, 3 weeks, 6 weeks
Lumbar Flexibility
Lumbar flexibility was measured using the sit-and-reach test, a combination of the flexibility of the M. erector spinae and hamstrings. The participant is seated in front of the test box keeping the knees fully extended and the feet dorsiflexed against the foot-support. The fingertips are placed together, one hand on top of the other. The participant is moving actively, slowly forward, bringing the body to the pain-free limit. The participant's hands move the block along the scale until the movement is terminated because the subject can go no farther. The final position is held with an isometric contraction for 2 seconds, and the distance is read on the scale. The test is repeated twice and an average score is taken for further analysis
Measured: Baseline, 3 weeks, 6 weeks
Lumbar Range of Motion (ROM)
Lumbar spine range of motion (ROM) was assessed using the ILEX machine's built-in goniometer. Participants performed three maximal dynamic backward-forward repetitions, with peak flexion and extension recorded electronically and summed to calculate the total ROM (º). The higher of two trials was used for analysis.
Measured: Baseline, 3 weeks, 6 weeks
Rating of Perceived Effort
Participants rated perceived effort (RPE-E) during resistance training using a 10-point Category-Ratio Scale (CR10). Immediately after each training session, the examiner asked the participant, "How hard do you think you're working?" Participants reported their perception verbally using a 0 (no exertion) to 10 (maximal exertion) scale while referencing a visual representation of the scale.
Measured: After each of the 12 training sessions (t1-t12), twice a week for 6 weeks
Rating of Perceived Discomfort
Participants reported perceived discomfort (RPE-D) using a 10-point Category-Ratio Scale. RPE-D reflects physiological discomfort associated with muscular fatigue, helping to differentiate effort from discomfort. Immediately after each training session, the examiner asked the participant, "How uncomfortable was the exercise?" Participants reported their perception verbally using a 0 (no discomfort at all) to 10 (maximal discomfort) scale while referencing a visual representation of the scale.
Measured: After each of the 12 training sessions (t1-t12), twice a week for 6 weeks
Rating of Thermal Sensation
Thermal sensation was measured using a 9-point Likert scale according to SN EN ISO 10551:2020, ranging from -4 ("very cold") to +4 ("very hot"), with 0 representing neutral. Participants were asked, "How does your back feel?" The question and response options were presented in German. Participants reported their thermal sensation verbally while referencing a visual representation of the scale
Measured: After each of the 12 therapy sessions (t1-t12), twice a week for 6 weeks
Rating of Perceived Comfort
Perceived comfort was assessed using a 5-point scale ranging from 0 ("comfortable") to 4 ("extremely uncomfortable"), with intermediate options 1 ("slightly uncomfortable"), 2 ("uncomfortable"), and 3 ("very uncomfortable"). Participants were asked, "How did the treatment feel?" The question and response options were presented in German. Participants reported their thermal sensation and comfort verbally while referencing a visual representation of the scale.
Measured: After each of the 12 therapy sessions (t1-t12), twice a week for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start29 Apr 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences and Arts of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Clijsen, University of Applied Sciences and Arts of Southern Switzerland
- Investigators
- Ron Clijsen, PhD, Principal investigator, University of Applied Sciences and Arts of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852872
- Sponsor's protocol ID
- 2023-02308_ILEX
- Other IDs
- 2023
- Acronym
- ILEX
- Status last verified
- Oct 2026
- First submitted
- 7 May 2024
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diathermy Therapy on Isolated Lumbar Extension (ILEX) Training
- ClinicalTrials.gov ID
- NCT06852872
- Acronym / sponsor ID
- ILEX / 2023-02308_ILEX
- Conditions
- Resistance Training, Healthy Participants Study
- Keywords
- Isolated lumbar extension training, lumbar muscle, Thermal Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Applied Sciences and Arts of Southern SwitzerlandUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Posted 30 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 edema.
At BL, participants will need to give written informed consent and be familiarized to the back extensor machine and Category-Ratio-Scale (CR10) for the assessment of perceived effort and discomfort as well as thermal sensation and thermal comfort. Baseline assessment will include epidemiological data such as age, sex, height, and weight. At all three measurements (BL, F/U 1, F/U 2), the lumbar extensor musculature thickness (M. erector spinae) is evaluated through the ultrasound system Mylab2 (Esaote, Maastricht, Netherlands), the lower back flexibility is examined using a sit-and-reach test, and the isometric back extension endurance is measured through the Biering-Sørrensen test. Finally, maximal range of motion (ROM) and maximal voluntary isometric contraction will be evaluated using the Myosom machine.
Participants will be randomly assigned to either the sham group, which will receive a 10-minute treatment with Tecar device (T-Plus, Wintecare SA, Chiasso, Switzerland) turned off and not sending radiofrequency before each exercise session, or the intervention group, which will undergo a 10-minute treatment with the Tecar device to induce 448kHz capacitive monopolar radiofrequency and facilitate warming up of deep tissues. After every treatment the participants will be asked to rate their thermal sensation and comfort. Skin temperature will be measured using an infrared thermal imaging (FLIR A615 series, Emitec Industrial, Rotkreuz, Switzerland) after the first and final Tecar treatment.
Training will take place twice a week, beginning with a dynamic warm-up of the lumbar extensor for 120s, followed by three sets of resistance training (RT) lasting 120s, 120s, and 150s respectively, and concluding with a final set of dynamic recovery lasting 60s. 30-second recovery will be provided between every set. A low load will be used for the warm-up and recovery. The load will be subsequently increased until volitional fatigue. Repetitions will be executed by taking three seconds from complete flexion to complete extension, ensuring standardization at 20 repetitions per minute. A metronome with 40 beats per minute will provide audible feedback. The Myosom machine emits an audible signal upon completion of each phase of the repetition to guarantee a complete range of motion is achieved. Subsequent to every training session, participants will be requested to provide their effort (RPE-E) and discomfort (RPE-D) values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: CRET Therapy, Other: ILEX trainingCapacitive Resistive Electric Transfer (CRET) therapy AND Isolate Lumbar Extension (ILEX) Training. |
| Sham Group | Sham comparator | Other: ILEX training, Other: CRET therapy shamSham Capacitive Resistive Electric Transfer (CRET) therapy AND Isolate Lumbar Extension (ILEX) Training. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy
- pain-free
- sufficient understanding of the German language
- able to give informed consent
- between 18 and 30
Key exclusion criteria (8 listed)
- pregnant
- medication
- surgery of lumbar spine
- knee or hip disorders
- low back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRET TherapyAlso: TECAR therapy, Diathermy therapyDiathermy therapy with a protocol to preheat the back extensor muscle | Other | Intervention group |
| ILEX trainingIsolated lumbar Extension Training | Other | Intervention group, Sham Group |
| CRET therapy shamAlso: TECAR therapy, Diathermy therapyDiathermy therapy withouth any radiofrequency as a sham intervention | Other | Sham Group |
Primary outcome
Maximal Isometric Force of the Back Extensors
Time frame: Baseline, 3 weeks, 6 weeks
Maximum voluntary isometric contraction (MVIC) of the back extensor was measured using the ILEX machine. With arms folded across the chest, participants performed a slow, continuous 2-3 s maximal-effort back extension against the fixed upper-back pad. Peak torque (N) was recorded electronically, and the higher of two trials was used for analysis.
8 secondary outcomes
Isometric Back Extension Endurance
Time frame: base line, 3 weeks, 6 weeks
Thickness of the Mm. Erector Spine
Time frame: Baseline, 3 weeks, 6 weeks
Lumbar Flexibility
Time frame: Baseline, 3 weeks, 6 weeks
Lumbar Range of Motion (ROM)
Time frame: Baseline, 3 weeks, 6 weeks
Rating of Perceived Effort
Time frame: After each of the 12 training sessions (t1-t12), twice a week for 6 weeks
Rating of Perceived Discomfort
Time frame: After each of the 12 training sessions (t1-t12), twice a week for 6 weeks
Rating of Thermal Sensation
Time frame: After each of the 12 therapy sessions (t1-t12), twice a week for 6 weeks
Rating of Perceived Comfort
Time frame: After each of the 12 therapy sessions (t1-t12), twice a week for 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Clijsen, PhD principal investigator
University of Applied Sciences and Arts of Southern Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRET Therapy and ILEX training in people with Resistance Training and Healthy Participants Study, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Isometric Force of the Back Extensors (time frame: Baseline, 3 weeks, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.