Study Results
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View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2021-08-15
2024-04-15
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Tango
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.
Rhythmic Auditory Stimulation
Rhythmically-entrained sensorimotor activity.
Home Exercise (HEX)
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 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week
Evidence-Based Exercise
This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week
Interventions
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Rhythmic Auditory Stimulation
Rhythmically-entrained sensorimotor activity.
Evidence-Based Exercise
This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week
Eligibility Criteria
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Inclusion Criteria
* Symptomatic for neuropathy
* postural control outside 70% CI for adults who are middle-aged without neurotrauma
* having completed taxane-based chemotherapy treatment at least 3 months ago;
* able to understand and comply with directions associated with testing and study treatments.
Exclusion Criteria
* poorly controlled diabetes (hgA1C \> 8);
* non-ambulatory or lower extremity amputation (assistive devices allowed);
* use of cytotoxic or immunotherapy during study (endocrine therapy allowed);
* participation in physical therapy during the study;
* contraindication to participate in Tango due to orthopedic issue (e.g., herniated vertebral disc);
40 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Lise Worthen-Chaudhari
Research Scientist
Principal Investigators
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Lise Worthen-Chaudhari, PhD, MFA
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States
Countries
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References
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Hackney ME, Earhart GM. Recommendations for Implementing Tango Classes for Persons with Parkinson Disease. Am J Dance Ther. 2010 Jun;32(1):41-52. doi: 10.1007/s10465-010-9086-y.
Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.
Worthen-Chaudhari L, Schnell PM, Hackney ME, Lustberg MB. Partnered dance evokes greater intrinsic motivation than home exercise as therapeutic activity for chemotherapy-induced deficits: secondary results of a randomized, controlled clinical trial. Front Psychol. 2024 Jun 19;15:1383143. doi: 10.3389/fpsyg.2024.1383143. eCollection 2024.
Lantis K, Schnell P, Bland CR, Wilder J, Hock K, Vargo C, Glover NA, Hackney ME, Lustberg MB, Worthen-Chaudhari L. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data. Trials. 2023 Sep 1;24(1):564. doi: 10.1186/s13063-023-07554-z.
Lantis KD, Schne P, Bland CR, Wilder J, Hock K, Glover NA, Hackney ME, Lustberg MB, Worthen-Chaudhari L. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trail and preliminary baseline data. Res Sq [Preprint]. 2023 Jun 29:rs.3.rs-2988661. doi: 10.21203/rs.3.rs-2988661/v1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2018-00310
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-15047
Identifier Type: OTHER
Identifier Source: secondary_id
2015C0090
Identifier Type: -
Identifier Source: org_study_id
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