Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The intervention will consist of 16 Argentine Tango (Tango) sessions, adapted for neurorehabilitation per Hackney and Earhart (2010). Delivered over 8 weeks at a frequency of 2x per week and duration of 1 hour per session, this program teaches the basics steps of partnered Tango dance.

The control group will consist of an evidence-based, structured home exercise program (HEX) based on the 8 week intervention described by Zimmer et al (2018) and recommended by physical therapists specializing in BC within our organization. This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hr training (i.e., endurance, resistance, and sensorimotor) performed 2x per week

Rhythmically-entrained sensorimotor activity.

Rhythmic Auditory Stimulation

This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hr training (i.e., endurance, resistance, and sensorimotor) performed 2x per week

Evidence-Based Exercise

Lise Worthen-Chaudhari, PhD, MFA

Group dance classes have been found to improve markers of quality of life and physical health (i.e., balance) among some populations engaged in rehabilitation, such as the elderly and individuals with Parkinson Disease. However, such interventions have yet to be studied among cancer survivors despite the relevance of quality of life and physical health within cancer survivorship. Group dance classes are a promising avenue in that they deliver activity-based medicine in a social context, thus potentially improving physical as well as psychosocial aspects of health. To further this avenue of inquiry, we propose to study the effect of dance-based interventions for cancer survivors.

Participants will be randomized (1:1) to one of two activity intervention arms: Argentine Tango dance or home exercise. Information about neuropathy symptoms, motion, falls incidence, and participant feedback about the interventions will be collected.

Aim1: To evaluate change in postural control over 16 sessions of Tango (exp) vs HEX (control) (n=26 per group) as primary endpoint. As secondary measures, to assess: balance function (i.e., TUG) and patient-reported outcomes (PROs) (i.e., symptoms, pain, fatigue, mood, quality of life) monthly including 1 month post-intervention completion; postural control and symptoms within-session; and falls incidence weekly for 6 months following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures sensitive to neuropathy disease state (i.e., sway variability and area).

Aim2: To evaluate change in gait variability after 16 sessions of Tango (exp) vs HEX (control) (n=26 per group; 1:1 randomization). As secondary measures, to analyze local and orbital dynamic stability (pre, post, and 1mo post-intervention), PROs (monthly), and falls incidence (weekly) following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures of gait variability (i.e., stride-to-stride variability in speed).

Tango for Neuropathy Among Breast Cancer Survivors

Novel Interventions for Chemotherapy-Induced Neuropathy

The Mini Balance Evaluation System Test short version (MiniBEST): evaluates sensory organization, anticipatory and reactive postural control, and dynamic gait indices on a scale from 1 to 28 points (28 represents the highest function measurable by the test); was recently recommended for use in studies of neuropathy; and discriminated BC survivors from controls in at least 1 prior study. Instrumentation of MiniBEST will enable the calculation of spatiotemporal, kinematic, and co-contraction measures

The Mini Balance Evaluation System Test short version (MiniBEST): evaluates sensory organization, anticipatory and reactive postural control, and dynamic gait indices on a scale from 1 to 28 points (28 represents the highest function measurable by the test); was recently recommended for use in studies of neuropathy; and discriminated BC survivors from controls in at least 1 prior study. Instrumentation of MiniBEST will enable the calculation of spatiotemporal, kinematic, and co-contraction measures.

root-mean square of the center of pressure (COP)

The Timed Up-and-Go test, or TUG, (\<2 min to administer) is a timed test of a person's ability to stand from a chair, walk 10 feet, turn around, and return to sitting with shorter times indicating better functional balance.

European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves.

The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity "right now" using a single item visual analog scale (VAS) on which participants will rate how much pain they are in "right now" on a scale of 1 to 10 (10 being high the worst pain imaginable).

The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue "right now" using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel "right now" on a scale of 1 to 10 (10 being high the worst fatigue imaginable).

the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study

the number of falls or near falls experienced by the participant since last evaluation/intervention session

the number of falls or near falls experienced by the participant in the 6 months post-intervention

National Institute on Aging (NIA)

Ohio State University Comprehensive Cancer Center

Research Scientist

Symptoms and General Pathology

Nervous System Diseases

Immune System Diseases

Rare Diseases

Fatigue

Myasthenia Gravis

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

Danish patients with myasthenia gravis seen at the Department of Neurology, Rigshospitalet

The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed for neuromuscular patients.

6-minute walk test

Linda K Andersen

The aim of this study is to investigate if rhythmic auditory stimulation can influence walking speed, during a 6MWT in patients with myasthenia gravis (MG).

Background

1. The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed.
2. Rhythmic auditory stimulation has repeatedly been shown to improve gait parameters in individuals with neurologic impairment.

The aim of this study is to investigate if rhythmic auditory stimulation can influence walking speed, during a 6MWT in patients with myasthenia gravis.

Patients with MG are asked to complete two 6MWTs separated by minimum 30 minutes of rest. Before the 6MWTs patient is instructed to walk 60 m as fast as possible, and their steps per minute (SPM) is recorded. When completing the 6MWTs, one of the tests is accompanied by music (m6MWT) with a beat per minute (BPM) corresponding to patients' SPM. The order of the 6MWTs is randomly decided by pre-ordered sealed envelopes.

Rhythmic Auditory Stimulation and Walking Speed in the 6-minute Walk Test

Does Rhythmic Auditory Stimulation Influence Walking Speed in the 6-minute Walk Test in Patients With Myasthenia Gravis?

The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.

Monitoring of heart rate by a pulse-watch prior, during (average heart rate for 6 minutes) and after the 6MWT. All three measurements are in the same units (beats per minute), and are registered directly from the pulse-watch, which the patient wear during the walk test.

Just after the completed 6MWT patients are asked to score the perceived exertion during walking. The scale is from 6 (no effort at all) to 20 (absolute maximal effort).

The Myasthenia Gravis composite score (MGC) covers 10 important functional domains most frequently involved in patients with MG. This scoring system is based on quantitative testing of muscle groups, or symptom history told by the patient, by means of a 4 point scale ranging from 0 (no symptoms) to 9 (severe symptoms). The scale measures ocular, bulbar, respiratory and limb function, grading each finding, and the total score ranges from 0(no myasthenic findings) to 50 (maximal myasthenic deficits).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tango for Neuropathy Among Breast Cancer Survivors	NCT05114005	Cancer, Breast Neuropathy	Rhythmic Audito... Evidence-Based ...	40 Years -	Ohio State University Comprehensive Cancer Center
Tango for Neuropathy Among Breast Cancer Survivors	NCT05114005	Cancer, Breast Neuropathy	Rhythmic Audito... Evidence-Based ...	40 Years -	Ohio State University Comprehensive Cancer Center
Rhythmic Auditory Stimulation and Walking Speed in the 6-minute Walk Test	NCT03905161	Myasthenia Grav...	6-minute walk t...	18 Years - 80 Years	Rigshospitalet, Denmark

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