Low Intensity Vibration for Breast Cancer Survivor Muscle Function

Overseen By Jackson Richey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Aromatase inhibitors

Must not be taking: Bisphosphonates, Denosumab

Disqualifiers: Bone disorders, Muscle disorders, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a device providing low-intensity vibrations, used twice daily for a year, can enhance muscle energy in breast cancer survivors starting aromatase inhibitor therapy. The study compares this approach to a group not receiving the vibration treatment. Women who have completed their main cancer treatments, do not exercise regularly, and plan to start aromatase inhibitor therapy might be suitable candidates. The goal is to determine if these vibrations can improve muscle power, particularly for those who don't exercise frequently. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for breast cancer survivors.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking bisphosphonates or denosumab, you must not have used them in the past 12 months. Also, if you are switching from tamoxifen to an aromatase inhibitor, there must be a 28-day gap between the last tamoxifen dose and the start of the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have used bisphosphonates or denosumab in the past 12 months. If you are on these medications, you may need to stop them to participate.

What prior data suggests that the Macrodyne LivMD plate is safe for breast cancer survivors?

Research has shown that the Macrodyne LivMD plate used for low-intensity vibration (LIV) therapy is generally safe. In past studies, participants tolerated this type of vibration therapy well. Some reported only mild itchiness, with no serious effects. Another study found that the vibration levels of 30–90 Hz from the plate are safe and do not cause harm. This indicates that the treatment is not only safe but also comfortable for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Low Intensity Vibration (LIV) for breast cancer survivors is unique because it offers a non-invasive way to potentially improve muscle function without the need for drugs or intense physical therapy. Unlike standard treatments that might include physical rehabilitation exercises or medication, the Macrodyne LivMD plate uses gentle vibrations to stimulate muscles, making it an innovative approach. Researchers are excited about this method because it could provide a safe, easy-to-use alternative that enhances muscle recovery with minimal effort, which is especially beneficial for those who may struggle with more rigorous forms of rehabilitation.

What evidence suggests that low intensity vibration is effective for improving muscle function in breast cancer survivors?

Research has shown that low intensity vibration (LIV) therapy, which participants in this trial may receive using the Macrodyne LivMD plate, can improve muscle and bone health in breast cancer patients. Studies have found that LIV increases bone density and strength, reducing the risk of fractures and osteoporosis. It also enhances muscle strength and function. This is particularly beneficial for patients beginning aromatase inhibitor therapy, which often leads to muscle weakness. Early evidence suggests that LIV may also boost energy levels, making daily activities easier. Overall, LIV therapy shows promise in supporting muscle function and overall health in breast cancer survivors. ^{1 5 6 7 8}

Who Is on the Research Team?

Tarah Ballinger, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for early stage breast cancer survivors who are about to start aromatase inhibitor therapy and don't regularly exercise. Participants should be post-menopausal or premenopausal with ovarian suppression, have a good performance status, weigh less than 275 lbs., able to stand unassisted for 10 minutes, and completed primary cancer treatments. Exclusions include severe heart conditions, muscle disorders, metastatic breast cancer, certain bone diseases, chronic renal disease or planned cochlear implant.

Inclusion Criteria

Your bone density test score is higher than -2.5.

I can take care of myself and am up and about more than 50% of my waking hours.

I am post-menopausal, meeting one of the specified conditions.

Exclusion Criteria

I have had a bone break easily in the past without major injury.

I do not have any health conditions that would stop me from safely participating in exercise-related study activities.

I have metastatic breast cancer and no other cancers needing active treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low intensity vibration (LIV) therapy for 10 minutes twice daily for 12 months

12 months

Monthly visits for compliance check

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Macrodyne LivMD plate

Trial Overview The study tests the effects of Low Intensity Vibration (LIV) on muscle function in breast cancer survivors using a Macrodyne LivMD plate. Patients will use this device twice daily for ten minutes over twelve months while their muscle power output on a stationary bike is measured against those who wait-listed as controls.

How Is the Trial Designed?

Group I: Macrodyne LivMD plate Experimental Treatment 1 Intervention

Group II: Wait-Listed Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

Local vibration training for 6 months significantly improved isometric muscle strength in postmenopausal women, with a 13.84% increase compared to the control group, indicating its efficacy for enhancing muscle strength.

However, the training did not result in any changes in bone mineral density, muscle mass, or overall physical performance, suggesting that while the vibration training is safe and beneficial for muscle strength, it may not impact other physical health aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Six-Month Local Vibration Training on Bone Density, Muscle Strength, Muscle Mass, and Physical Performance in Postmenopausal Women. Tankisheva, E., Bogaerts, A., Boonen, S., et al.[2022]

Whole-body vibration (WBV) at frequencies of 20 and 30 Hz resulted in higher muscle activity in breast cancer survivors compared to higher frequencies, indicating these levels may be more effective for muscle engagement.

Despite increased muscle activity at lower frequencies, the perceived exertion (RPE) was lower at 20 and 30 Hz, suggesting that these frequencies provide a more comfortable and effective exercise option for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body vibration in breast cancer survivors: a pilot study exploring its effects on muscle activity and subjectively perceived exertion. Van Ruymbeke, B., Boone, J., Coorevits, P., et al.[2015]

After a one-year break from an 18-month low-magnitude high-frequency vibration (LMHFV) treatment, elderly women who received the intervention maintained better muscle strength and balancing ability compared to those who did not receive any treatment.

The study, involving 59 elderly women, showed that the positive effects of LMHFV on muscle performance and quality of life persisted even after stopping the intervention for a year, indicating its long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in muscle performance after one-year cessation of low-magnitude high-frequency vibration in community elderly. Cheung, WH., Li, CY., Zhu, TY., et al.[2018]

Local vibration applied to specific muscles can significantly enhance muscle strength in healthy adults, as shown in a review of 11 studies that met the inclusion criteria.

Despite the positive findings, there was considerable variation in the vibration parameters used across studies, indicating a need for more controlled research to better understand the optimal conditions for muscle strength improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of localised vibration on muscle strength in healthy adults: a systematic review. Alghadir, AH., Anwer, S., Zafar, H., et al.[2022]

Vibration applied to the patellar tendon significantly increased motor unit firing rates in the vastus lateralis muscle during a 40% maximal voluntary contraction, indicating enhanced muscle activation.

Despite the increase in firing rates with vibration, there were no changes in electromyography (EMG) amplitude, suggesting that vibration affects motor unit behavior without altering overall muscle output.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of prolonged vibration on motor unit behavior. Mosier, EM., Herda, TJ., Trevino, MA., et al.[2018]

Vibration therapy (VT) at 35 Hz significantly improves grip endurance time in healthy individuals, indicating its potential to enhance muscle performance, although it does not significantly affect grip strength.

The study involved 10 healthy men and found that VT can be beneficial for neuromuscular performance in the upper extremities, suggesting its application in rehabilitation and sports therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibratory massage therapy on grip strength, endurance time and forearm muscle performance. Alam, MM., Khan, AA., Farooq, M.[2021]

Low magnitude, high frequency vibration (LMHFV) is emerging as a promising therapy for improving bone structure and muscle performance, particularly in conditions like osteoporosis that significantly affect quality of life.

Research is expanding on how LMHFV influences cellular responses in the musculoskeletal system, including its effects on bone-forming cells (osteogenesis) and fat-forming cells (adipogenesis), although the exact mechanisms of action remain poorly understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration stimuli and the differentiation of musculoskeletal progenitor cells: Review of results in vitro and in vivo. Edwards, JH., Reilly, GC.[2020]

In a study of 62 postmenopausal women using low-intensity vibration platforms for 20 minutes, 5 times a week over 12 months, significant improvements were observed in muscle strength, balance, and mobility compared to a control group of 60 women who did not change their activity levels.

The vibration platform group showed notable enhancements in various strength and mobility tests, with no reported side effects, indicating that this intervention is both effective and safe for improving neuromuscular function in osteopenic women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body vibration improves neuromuscular parameters and functional capacity in osteopenic postmenopausal women. Dutra, MC., de Oliveira, ML., Marin, RV., et al.[2022]

In a study involving 19 participants, it was found that the collision force between the vibration platform and the participant's heel is the primary factor influencing the reflex activity of the soleus muscle during low-amplitude whole-body vibration (WBV).

Vibration frequencies ranging from 25 to 50 Hz were tested, but the key takeaway is that the amplitude of muscle reflex activity is mainly determined by the collision force rather than the frequency of vibration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration parameters affecting vibration-induced reflex muscle activity. Cidem, M., Karacan, I., Cakar, HI., et al.[2018]

Vibration therapy (VT) was found to be safe and well-tolerated in a pilot study with 11 patients with congenital myopathy, showing a median compliance of 75%.

After 12 weeks of VT, participants experienced significant improvements in motor function performance, including a 2.4 unit increase in total motor function score and a 0.11 m/s increase in chair rising test velocity, indicating its potential effectiveness for muscle and motor health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and efficacy of 12-week side-to-side vibration therapy in children and adolescents with congenital myopathy in New Zealand. Adaikina, A., Derraik, JGB., Power, LC., et al.[2022]

In a study involving 13 recreationally active male university students, whole-body vibration (WBV) at 45 Hz significantly increased muscle activity in four leg muscles during dynamic squats, except for the tibialis anterior, compared to squats without WBV.

Adding a light external load (30% of body mass) further enhanced muscle activity during squats when combined with WBV, indicating that using external loads with WBV can effectively boost muscle engagement during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of muscle activity for loaded and unloaded dynamic squats during vertical whole-body vibration. Hazell, TJ., Kenno, KA., Jakobi, JM.[2016]

In a study of 99 breast cancer patients, both the cross-sectional area and muscle attenuation (quality) of skeletal muscle significantly decreased over the 12 months leading up to death, indicating a decline in muscle health during this period.

Statistical analysis revealed significant reductions in muscle quantity and quality at multiple time points, suggesting that monitoring muscle changes could be important for managing care in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skeletal muscle loss and prognosis of breast cancer patients. Kubo, Y., Naito, T., Mori, K., et al.[2018]

A study involving 117 frail elderly participants showed that 16 weeks of whole-body vibration (WBV) exercise significantly improved mobility and function, with benefits lasting up to 12 months after the intervention.

WBV exercise was safe and well-tolerated, with high compliance rates (93%), and it outperformed control and simulated WBV groups in functional tests, demonstrating its effectiveness as a training tool against age-related declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Whole-Body Vibration Training on the Physical Function of the Frail Elderly: An Open, Randomized Controlled Trial. Wadsworth, D., Lark, S.[2020]

Citations

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Low Intensity Vibration for Breast Cancer Survivor Muscle ... This trial tests if gentle body vibrations can help improve muscle and bone health in early-stage breast cancer patients who are starting a specific therapy ...

2. clinicaltrial.be clinicaltrial.be/en/details/66769?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Effect of Low Intensity Vibration (LIV) on Aromatase Inhi... The primary endpoint is the 12-month change in energetic capacity since baseline. Primary Objective To compare the effect of LIV delivered for ...

3. marodyneliv.co.uk marodyneliv.co.uk/breast-cancer-and-liv-therapy/

New developments: breast cancer and LiV therapy LiV has been shown to enhance bone density and strength, reducing the risk of fractures and osteoporosis. Improved muscle strength and function: LiV can improve ...

4. youtube.com youtube.com/watch?v=zjjmy069zvY

Low Intensity Vibration Therapy: New Hope For Cancer ... Physical Therapist Margaret Martin discusses low intensity vibration therapy, bone health, and cancer with leading researchers Theresa Guise ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8707128/

Physical Exercise with or without Whole-Body Vibration in ... In this study, we aimed to assess the safety and efficacy of physical exercise, with or without whole-body vibration (WBV), in patients with ...

6. ctv.veeva.com ctv.veeva.com/study/effect-of-low-intensity-vibration-liv-on-aromatase-inhibitor-induced-musculoskeletal-dysfunction

Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor The purpose of this study is to compare the effect of low intensity vibration (LIV) delivered for 10 minutes twice daily for 12 months on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5385164/

Feasibility and tolerability of whole‐body, low‐intensity ... 32 The vibration frequency delivered by the Marodyne LivMD plate, 30–90 Hz, is similar to the frequency found to be safe and without deleterious effects on ...

8. marodyne.us marodyne.us/products/marodyne-liv-low-intensity-vibration-device?srsltid=AfmBOorSRB_VwvuTZmxJ0E2kmOyF45lWgdg5DOE_TWymVaYW5zNxOX7V

Marodyne LIV Low Intensity Vibration Device – MarodyneLiV Marodyne LiV is a third generation low-intensity vibration device that safely improves muscle strength, function, and circulation. Buy now.