Muscle Tone Increased
Conditions
Keywords
muscle strengthening, muscle tone
Brief summary
Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.
Detailed description
This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.
Interventions
DEVICEBTL 799-2
High power magnet system
Sponsors
BTL Industries Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Voluntarily signed informed consent form * BMI ≤ 30 kg/m2 * Women of child-bearing potential are required to use birth control measures during the whole duration of the study * Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation * Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation
Exclusion criteria
* Cardiac pacemakers * Implanted defibrillators, implanted neurostimulators * Electronic implants * Pulmonary insufficiency * Metal implants * Drug pumps * Application in the head area * Application in the heart area * Malignant tumor * Injured or otherwise impaired muscles * Fever * Pregnancy * Sensitivity or allergy to latex * Breastfeeding * Following recent surgical procedures when muscle contraction may disrupt the healing process * Application over areas of the skin which lack normal sensation * Scars, open lesions and wounds at the treatment area * Unrepaired abdominal hernia * Patients after Cesarean section delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in adipose and muscle tissue measured via ultrasound imaging | 7 months | To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's satisfaction measured via questionnaires | 7 months | To determine the patient's satisfaction with study treatment for non-invasive strengthening and toning of arms, lower limbs and oblique muscles.The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome where the level of agreement between strongly agree and strongly disagree should indicate the participant's satisfaction with the therapy. |
| Incidence Of Treatment-Related Adverse Events | 7 months | To determine side effects and adverse events (AE) associated with the BTL 799-2 treatment of the arms, lower limbs and oblique muscles. Safety outcomes will include an evaluation of the treatment area to assess and evaluate the following: * Muscle pain * Temporary muscle spasm * Temporary joint or tendon pain * Local erythema or skin redness |
Countries
United States
Outcome results
None listed