Nervous System Diseases

All Conditions

Peripheral Nervous System Diseases

Neuromuscular Diseases

Participants randomly assigned to the UC group will serve as controls and will be tested at the same time points as the WBV group. The UC group will be asked not to change their physical activity or dietary habits across the intervention period and we will track any changes using a questionnaire.

Participants assigned to the WBV group will participate in twice daily 10-minute WBV training sessions, 7 days a week. Each WBV session will consist of a series of timed stands on the vibration platform (Marodyne LiV). During a timed stand, participants will perform slow controlled weight shifting exercises and gentle squats. The vibration frequency will be set at 30Hz and the amplitude set at 50-200 microns, for a total body acceleration of 0.4g+/-20%.

Whole Body Vibration

Kerri Winters-Stone, PhD

This clinical trial studies how well whole body vibration works in improving the health and functioning of participants with chemotherapy-induced peripheral neuropathy. Peripheral neuropathy is a condition caused by exposure to chemotherapy drugs that may involve numbness/tingling and/or pain in the hands and feet, which can have adverse effects on daily life. Whole body vibration may cause weight loss and improve mobility and pain levels in cancer survivors who report symptoms of peripheral neuropathy.

PRIMARY OBJECTIVES:

I. Determine the feasibility and safety of whole body vibration (WBV) in adult cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).

II. Determine the effect of WBV training on physical functioning in adult cancer survivors with CIPN.

III. Explore the effect of WBV training on symptom relief (neuropathy symptoms, pain, fatigue) and readiness to exercise in adult cancer survivors with CIPN.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (WBV): Participants complete two 10-minute WBV sessions per day, 7 days per week for 12 weeks.

GROUP II (USUAL CARE \[UC\]): Participants receive usual care and keep their same physical activity or dietary habits over 12 weeks.

After completion of study treatment, participants are followed up at 12 weeks.

Whole Body Vibration for the Improvement of Health and Functioning in Participants With Chemotherapy-Induced Peripheral Neuropathy

A Novel Therapeutic Intervention to Restore Health and Functioning in Persons With Chemotherapy-Induced Peripheral Neuropathy

What data in particular will be shared? All individual quantitative participant data collected during the trial, after deidentification.

What other documents will be available? None

With whom? Investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed.

For what types of analyses? To achieve aims in the approved proposal.

The number of participants enrolled during the recruitment period.

Adherence = % of sessions attended and compliance = % of each session completed.

Compliance = % of each session completed.

An in-house survey will ask about adverse events (e.g., bone pain, nausea) that occur during the intervention. The number of discrete moderate and severe adverse events will be summed as a single variable.

Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.

Functional mobility will be measured by the Timed Up and Go (TUG) test which measures the time that it takes a person to rise from a chair, walk 7 m, turn around and return and sit in the chair.

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the sway velocity (m/s) during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the sway area (m2/s3) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the amount (m/s2) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

Chronic changes in symptoms will be assessed at 0 and 12 weeks using the Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx). The questionnaire consists of the 27 item FACT-G, plus 11 items that specifically measure chemotherapy-induced neuropathy symptoms and concerns. Higher scores indicate worse symptoms.

Fatigue overall will be measured both before and after each whole body vibration session using a visual analog scale to identify any acute symptom relief from training. The scale ranges from 0 (no fatigue) to 10 (worst fatigue).

Chronic changes in fatigue will be assessed using the PROMIS Fatigue Scale. This instrument includes 8 items rated on a 5 point scale from "not at all" to "very much". Higher scores indicate worse fatigue.

Pain in the feet will be assessed both before and after each session using a visual analog scale to identify any acute symptom relief from training. The scale ranges from 0 (no pain) to 10 (worst pain).

Chronic changes in pain will be assessed using the Brief Pain Inventory (BPI). The instrument has 2 subscales: pain severity and pain interference. Severity is determined by the average of 4 items rated from 0 (no pain) to 10 (pain as bad as you can imagine). Pain interference is determined by the average of 7 items rated from 0 (does not interfere) to 10 (completely interferes).

Body mass index will be calculated as kg/m2.

Exercise readiness will be assessed using the stage of change for exercise questionnaire. This is a categorical instrument with 5 options that indicate a person's readiness to engage in regular physical activity. Options that suggest engagement in more regular exercise are better.

Perceived physical function will be measured by self-report using the Late-Life Function and Disability Instrument (LLFDI).

The number of meters that participants can walk in 6-minutes will be recorded.

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Syndrome

Polycystic Ovary Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

the patient will be received whole body vibration for three times/ week in addition to aerobic exercise for 3 times per week, 45 minutes per session for eight weeks

Moderate intensity aerobic exercise in form of walking on treadmill for 3 times per week, 45 minutes per session for eight weeks

the patients will stand on whole body vibration device with maintaining squatting position while keeping their trunk extended. The first training session will be consisted of three sets of 1 min and will be separated by a 1-min of standing rest. intensity will 1 mm. Then one set will be added every session

whole body vibration

Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks

Treadmill

Mai M Ali Shehata, lecturer

The purpose of this study is to investigate the effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome

polycystic ovarian syndrome is a complex endocrine condition characterized by metabolic abnormalities such as insulin resistance, excess weight or obesity, diabetes, and an increased risk of cardiovascular disease.Despite previous studies reported that physical exercise improves insulin resistance in females with polycystic ovarian syndrome, there is no study yet investigate the effect of whole body vibration on insulin resistance

Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome

Estimate insulin resistance (IR), it will be calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.

The formula = waist circumference / hip circumference.

Cairo University

Lecturer

Skin and Connective Tissue Diseases

Breast Neoplasms

Obesity

Hot Flashes

Breast Diseases

Skin Diseases

whole body vibration training

study aim is to determine the effect of whole body vibration training (WBVT) on body mass index, serum prolactin concentration as a risk factors for breast cancer and severity of hot flashes in obese postmenopausal women.

Menopause is a physiological process characterized by spontaneous cessation of menstrual cycle lasting at least 12 months, it is normally occurring in women aged 45 - 55 years . Postmenopausal women have higher prevalence of menopausal symptoms that significantly affect their quality of life more than pre- and perimenopausal women .

Increased adiposity, as measured by high body mass index, is associated with more severe menopausal symptoms also, obese female has a high risk lifestyle for the development of post-menopausal breast cancer .

The link between BMI and breast cancer risk is likely to be due to increased concentrations of bioavailable estradiol, which results in turn from an increase in the production of estrogens by aromatase in the adipose tissue, conversion of hormones in fatty tissue and a decrease in the serum concentration. This is likely to explain the higher risk of breast cancer in overweight post-menopausal women .

Menopause is also associated with atherogenic changes, including a worsening of CVD risk factors and decreased aerobic fitness compared with premenopausal women.

This initially may be due to a decrease in endogenous estrogen levels, and likely further exacerbated by increased adiposity and reductions in exercise habits or physical activity levels.

Post menopausal women recorded a high serum prolactin concentration however, they have a significant chance of normalizing their prolactin levels.

Serum prolactin levels rise transiently after several physiological states including pregnancy, breast-feeding, exercise, meals, sexual intercourse, minor surgical procedures, general anesthesia, other forms of acute stress and menopause.

Estrogen is another key regulator of prolactin and has been shown to increase the production and secretion of prolactin from the pituitary gland. In addition to dopamine and estrogen, a whole range of other hormones can both increase and decrease the amount of prolactin released in the body, with some examples being thyrotropin-releasing hormone, oxytocin and anti-diuretic hormone .

Whole-body vibration training is a promising adjunct intervention therapy for management of obesity, as there is few evidence that it can reduces body mass index and enhances muscles strength.

In initial stage of obesity management, WBVT is highly recommended because it allows a mild joints stress, deconditioning for obese patient with poor motivation because it achieve its target without provoking an excessive fatigue. In addition, Passive vibrations do not involve voluntary movement and need a lower contribution of central command, so WBVT is as effective as aerobic and resistance exercise in reducing fat mass and moderating the deficit of the relative muscle strength . Lastly, WBVT may be effective in vascular health promotion and prevention in young obese women.

Whole body vibration training(WBVT) has been recognized as an effective alternative exercise modality to resistance exercise for its ability in enhancing force and power, generating capacity in skeletal muscle, increasing bone mass, improving cardiovascular function, reducing fat mass and moderating the deficit of the relative muscle strength. Unfortunately, the effect of resistance exercise on prolactin has not been extensively studied .

So, this study was conducted to evaluate the effect of whole body vibration training on BMI, waist circumference, serum prolactin concentration and hot flashes in obese postmenopausal women.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Whole Body Vibration for the Improvement of Health and Functioning in Participants With Chemotherapy-Induced Peripheral Neuropathy	NCT04170075	Chemotherapy-In... Hematopoietic a... Malignant Solid...	Whole Body Vibr...	18 Years -	OHSU Knight Cancer Institute
Whole Body Vibration for the Improvement of Health and Functioning in Participants With Chemotherapy-Induced Peripheral Neuropathy	NCT04170075	Chemotherapy-In... Hematopoietic a... Malignant Solid...	Whole Body Vibr...	18 Years -	OHSU Knight Cancer Institute
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome	NCT05215223	Polycystic Ovar... Insulin Resista...	whole body vibr... Treadmill	20 Years - 35 Years	Cairo University
Whole Body Vibration Training and Breast Cancer Risk Factors	NCT04708093	Breast Cancer	whole body vibr...	50 Years - 60 Years	Cairo University
Whole Body Vibration Training and Breast Cancer Risk Factors	NCT04708093	Breast Cancer	whole body vibr...	50 Years - 60 Years	Cairo University

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