Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients
Condition: Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to better understand whether or not children with ALL can
      complete an exercise program during treatment and whether or not that program may impact
      peripheral neuropathy. Researchers will also study changes in the blood and body that may
      occur during the program by collecting samples of blood at various times during the study.

      Aim 1: Evaluate the feasibility and acceptability of EX as an intervention for VIPN in
      pediatric patients with ALL.

      Aim 2: Estimate preliminary effect sizes of the EX intervention.
    

Detailed description: 
      Baseline visit (week 6):

      This visit may take up to 1.5 hours total.

        -  The subject's exercise therapist will meet with them to discuss what they can expect
           throughout the program period. The subject will receive their exercise DVD to be used
           for at-home exercise sessions.

        -  The subject will be asked questions about how they are feeling and their general
           well-being. The subject will also be asked to complete several questionnaires about
           their neuropathy, confidence level about completing the program, support and
           expectations.

        -  The subject will be given a Fitbit with instructions about how and when to use it.

        -  The subject will have a sample of blood collected (15mL or about 1 tablespoon). The
           study team will time this blood draw to occur when they are already having blood drawn
           for routine clinical treatment.

        -  The subject will have a physical fitness test, which includes body measurements such as
           weight, height and blood pressure; also tests for physical strength, endurance and
           oxygen consumption. At the same time the subject is given the physical fitness test they
           will also be asked to not eat for 1 hour before this session.

        -  The subject will complete their first exercise session with their therapist.

      Weeks 6-13:

      During weeks 6-13 (8 weeks total), the subject will be asked to exercise for at least 15
      minutes 6 times per week using the instructional DVD that was provided to them. The exercise
      the subject does will be tailored to their age range (either age 5-10 or 11-18) and will
      consist of strengthening and aerobic activities. The subject will also be asked to keep an
      exercise log that is provided by the study to record their exercise activity including how
      they felt when they exercised. The subject will be asked to perform one of their exercise
      sessions during weeks 8, 10, and 12 at Riley Hospital with their exercise therapist. The
      study team will coordinate this visit to occur during one of their regularly scheduled office
      visits. Post-program visit (week 14) This visit may take up to 1.5 hours total.

        -  The subject will be asked questions about how they are feeling and their general
           well-being. The subject will also be asked to complete several questionnaires about your
           neuropathy, confidence level about completing the program, support and expectations.

        -  The subject will have a sample of blood collected (15mL or about 1 tablespoon). The
           study team will time this blood draw to occur when they are already having blood drawn
           for routine clinical treatment.

        -  The subject will repeat the physical fitness test, which includes body measurements such
           as weight, height and blood pressure; also tests for physical strength, endurance and
           oxygen consumption. During the last session (week 14) the subject will also be asked to
           not eat for 1 hour before this session.

        -  The subject will be asked to complete a satisfaction survey.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Exercise, questionnaires and blood draws.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment