Welcome!
We know you might have questions about our research study.
As we age, staying active and independent becomes more important—and more challenging. Aging is associated with decreased muscle endurance and strength, which is accelerated by a sedentary lifestyle.
Noninvasive technology, such as patches, offers users the potential for health and wellness benefits without stimulants entering the body, given its absence of ingredients. The Lifewave X39 patch can potentially improve muscle strength and endurance using photo-biomodulation technology.
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
1.Please click on the video Screen Below to Watch the Introduction to the Muscle Strength & Endurance study
In this video, you will find the purpose of this study, the study design, risks and benefits and what is expected from the participant and if you decide to participate. After listening to this recording, please read the informed consent and assent forms and the Frequently Asked Questions.
Muscle Strength & Endurance Introduction Video
2.Please Review the ICF Form here.
Please review the Informed Consent Form. You do not need to sign this copy but will be required to sign an electronic copy when you decide to join the study and before screening can begin.
3. Frequently Asked Questions
What is the purpose of this clinical study?
- This study will explore if the study product, X39, is effective and safe in improving muscular strength and endurance in healthy older adults.
- The purpose of the trial is to evaluate whether wearing the X39 patch daily for 28 days can improve muscle performance, recovery, and overall wellness in people aged 50 and older with low physical activity.
What is the study product? What is in it?
- If you are enrolled into the study, you will receive either the study product or the placebo.
- The study patches contains: Water, stabilized oxygen, stereoisomers of organic sugars and stereoisomers of amino acids.
- The study product is a non-transdermal patch (a patch that does not release any medication into the body) called X39. X39 uses a technology called photo biomodulation, where the body’s own natural heat (infrared energy) activates the patch’s materials to stimulate biological responses when placed on the skin surface at acupuncture points
- The placebo patches contains: Laminate film, non-woven material, adhesive medical tape with backing, distilled water.
Are there any side effects?
- Skin redness, itching, or irritation at the application site
- Allergic reaction to the adhesive (rare)
- Risk of muscle strain or joint discomfort from the exercise portion
How often and when do I need to use study product?
- Apply one patch every morning to clean, dry skin (either the back of the neck or below the bellybutton).
- Wear it for approximately 12 hours then remove it.
- If the patch falls off, clean and dry the application site, reapply a new one and record it in your diary.
- If you forget a dose, apply when you remember and wear it for 12 hours or for the remaining part of the day.
- If you forget to remove the patch and wear it longer than approximately 12 hours, please remove it as soon as you remember.
How should I wear the patch during the study
- Beginning on Day 1 (the day after you confirm receipt of the study product), you will apply the patch to the back of the neck or directly below the bellybutton on clean dry skin first thing each morning and remove after 12 hours or before going to bed. Make sure your skin is clean and dry before applying the patch. If the patch gets wet after it is applied, it will continue to work.
- Please maintain the same site of application and same time of day the patch will be applied and removed for the entire duration of the study.
- If the patch falls off over the course of the 12 hours, please clean and dry the application site and reapply a new patch for the remainder of the 12-hour daily wear.
- If you forget to apply the patch on one day, apply it as soon as you remember and wear it for 12 hours or the remainder of the day ensuring you take it off before you go to sleep (even if the patch has not been applied on for the full 12 hours).
- If you forget to remove the patch and wear it longer than approximately 12 hours, please remove it as soon as you remember
- You will keep all used and unused patches and have them available for counting during your virtual visits
How/when will I receive the product?
- You will receive your study patches during your clinic visits (Visit 1, 2, and 3).
- You will return unused patches at each follow-up.
- How/ when can I find out if I got the investigational product or the placebo?
- This is a triple-blind study, which means you, the study staff, and the sponsor will not know which group you are in.
- After the study ends and data is analyzed, an e-mail will be sent informing you of which group you were in.
How long will the study last?
Once you receive your study product your participation will continue for approximately about 28 days (4 weeks), with 4 in-clinic visits with at-home exercises and daily diary tracking.
What does randomization mean?
- Randomized means that you will be assigned by chance, like flipping a coin, to a study group (either the study product or the placebo).
- This is a triple-blind study, so neither you, the study doctor, nor the researchers analyzing the data will know which group you have been randomized to or which product you will receive (investigational product or placebo). We will dispense study products based on randomization.
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Do I have to come into the clinic for any assessments?
Yes. You will have 4 clinic visits:
- Visit 1: Screening + Baseline (Day 0)
- Visit 2: Day 7 ± 2 days
- Visit 3: Day 14 ± 2 days
- Visit 4: Day 28 ± 2 days (End of Study)
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Who/how do I contact if I have any questions?
If you have any questions, you can reach out to our clinic at the following email address: clinic@kgkscience.com
What is the compensation for participating?
For your time and participation in the study, you will be compensated a total of 600 CAD if you complete the entire study and all associated requirements.
How and when will I receive my compensation for participating?
- After completion of the study, you will receive your compensation on a ClinCard. You will receive the Clincard at your final visit.
- Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
Is my participation confidential?
- Yes! KGK Science research staff will keep all of your personal medical information confidential to the extent required by law. You will not be identified in any publication that may result from the study.
