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

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 and don't exercise regularly. The vibrations are done for short periods each day.

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 safety data exists for Low Intensity Vibration treatment?

The study titled 'Feasibility, safety, and efficacy of 12-week side-to-side vibration therapy in children and adolescents with congenital myopathy in New Zealand' provides relevant safety data. It reports that vibration therapy was well-tolerated with only occasional mild itchiness, indicating it is safe. The study supports further exploration of vibration therapy's potential health benefits. ^{1 2 3 4 5}

Is low intensity vibration therapy safe for humans?

Low intensity vibration therapy has been shown to be safe in studies involving different conditions, such as congenital myopathy in children and osteopenia in postmenopausal women, with only mild side effects like itchiness reported. ^{1 2 3 4 5}

Is the treatment Macrodyne LivMD plate a promising treatment for improving muscle function in breast cancer survivors?

Yes, the Macrodyne LivMD plate, which uses low intensity vibration, is a promising treatment. Research shows that vibration therapy can improve muscle strength and performance by activating more muscle fibers, which can be beneficial for breast cancer survivors looking to enhance their muscle function. ^{2 6 7 8 9}

How is the Low Intensity Vibration treatment unique for improving muscle function in breast cancer survivors?

The Low Intensity Vibration (LIV) treatment is unique because it uses gentle vibrations to stimulate muscle strength and performance, which is different from traditional exercise or medication-based therapies. This approach is non-invasive and can be particularly beneficial for individuals who may have limitations in performing regular physical activities. ^{2 6 7 8 9}

What data supports the idea that Low Intensity Vibration for Breast Cancer Survivor Muscle Function is an effective treatment?

The available research shows that Low Intensity Vibration (LIV) does not significantly improve muscle activity or perceived exertion in breast cancer survivors compared to healthy controls. In a study where participants performed exercises on a vibration platform, there were no significant differences in muscle activity or how hard the exercise felt between the two groups. This suggests that LIV might not be more effective than other treatments for improving muscle function in breast cancer survivors. ^{6 10 11 12 13}

What data supports the effectiveness of the treatment Low Intensity Vibration for improving muscle function in breast cancer survivors?

Research on whole-body vibration (WBV) in breast cancer survivors showed no significant differences in muscle activity compared to healthy controls, but other studies suggest WBV can improve physical function in the frail elderly, indicating potential benefits for muscle function. ^{6 10 11 12 13}

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

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]

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]

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]

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]

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]

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) 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 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]

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]

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) 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]

Citations

1. England 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. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Effect of localised vibration on muscle strength in healthy adults: a systematic review. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Skeletal muscle loss and prognosis of breast cancer patients. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Greece pubmed.ncbi.nlm.nih.gov

Improvement in muscle performance after one-year cessation of low-magnitude high-frequency vibration in community elderly. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Vibration stimuli and the differentiation of musculoskeletal progenitor cells: Review of results in vitro and in vivo. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The influence of prolonged vibration on motor unit behavior. [2018]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of muscle activity for loaded and unloaded dynamic squats during vertical whole-body vibration. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Whole-body vibration improves neuromuscular parameters and functional capacity in osteopenic postmenopausal women. [2022]

11. United States 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. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Vibration parameters affecting vibration-induced reflex muscle activity. [2018]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of vibratory massage therapy on grip strength, endurance time and forearm muscle performance. [2021]