A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Number of Screened Patients Who Participate and Complete the Study
Study Overview
Brief Summary
The purpose of this study is to evaluate the effects on strength, balance, and neuropathic symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group exercise program designed to improve lower extremity strength and balance with persons with oxaliplatin induced peripheral neuropathy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Prior history of colon cancer
- •Completed oxaliplatin based chemotherapy at least 6 months prior to enrollment
- •Report numbness, tingling, or pain of the lower extremities ≥ 4 by chemotherapy induced peripheral neuropathy (CIPN) Visual Analog Rating
- •Karnofsky performance status of at least 60%
- •Able to read, write, and understand English
Exclusion Criteria
- •Patients will be excluded from the study if they live outside of a 30 mile radius of the University of South Florida, if they are currently undergoing chemotherapy or radiation therapy, or if they regularly (at least once a week) participate in strength or balance training exercises. The investigators will not exclude participants if they are participating in aerobic exercise, but we will collect that information so that the investigators may control for aerobic exercise in our data analysis.
Arms & Interventions
Excercise and Questionnaire
12 week exercise program followed by questionnaire.
Intervention: 12 Week Exercise Program (Other)
Outcomes
Primary Outcomes
Number of Screened Patients Who Participate and Complete the Study
Time Frame: 10 Months
To evaluate feasibility, the percentage of patients screened to percentage enrolled in the study and the percentage enrolled to percentage that completes the study will be calculated. Patients who do not complete the study will be contacted to determine why they were unable to complete the study and the reasons will be recorded. How many sessions were attended will also be recorded.
Secondary Outcomes
- Number of Participants With Measured Improvement(10 Months)
- Number of Participants Who Experience Side Effects(10 Months)