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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.
Baseline visit (week 6):
This visit may take up to 1.5 hours total.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental | Clinic and at home exercise sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Exercise, questionnaires and blood draws. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Greater Than 50% Compliance to Exercise Regimen | Subjects will complete greater than 50% of exercise sessions during 8 week intervention. Subject report satisfaction with the intervention via questionnaires. | 8 weeks |
| Acceptability - Parent Satisfaction Survey | Parents will also be asked to complete a satisfaction survey regarding the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items. Scores were on a Likert scale 1-5, 1 - strongly disagree and 5 - strongly agree. The total range is 13-65 with 65 being the greatest satisfaction possible and 13 being the worst satisfaction possible. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability - Patient Satisfaction Survey | Patients will provide feedback on the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items. The scale is 1-5 with 1 - strongly disagree and 5 - strongly agree. The total range is 13-65 with 65 being the greatest satisfaction possible and 13 being the worst satisfaction possible. | 8 weeks |
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Inclusion Criteria:
Participants will be eligible for this study if they are:
Exclusion Criteria:
Participants will be ineligible for this study if they have:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Renbarger, MD | Riley Hospital for Children - Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children - Indiana University | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Intervention | Clinic and at home exercise sessions. Exercise: Exercise, questionnaires and blood draws. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Intervention | Interventions administered for clinic and at home exercise sessions: Exercise-15 minute sessions daily that include resistance and aerobic training. All training sessions will be provided via an online video they can access at any time. In addition, each session will address 3 core, 3 lower body and 3 upper body exercises that will last 50 seconds each for a total of 10 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Greater Than 50% Compliance to Exercise Regimen | Subjects will complete greater than 50% of exercise sessions during 8 week intervention. Subject report satisfaction with the intervention via questionnaires. | Looking at % sessions completed during 8 week program per subject. | Posted | Count of Participants | Participants | 8 weeks |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Intervention | Clinic and at home exercise sessions. Exercise: Exercise, questionnaires and blood draws. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Renbarger, MD | Indiana University | 317-944-8784 | jarenbar@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2019 | Jul 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Pediatric Neuropathy | Total Neuropathy Score Pediatric Version; Range for each subscale is 0 to 4 with 0 being normal and 4 being the worst neuropathy. The total range is 0-36. 0 being no neuropathy. 36 being highest neuropathy possible. | 8 weeks |
| Quality of Life - Changes in Quality of Life From Pre Intervention to Post Intervention a Total of 8 Weeks. | Quality of Life: Pediatric Quality of Life Inventory; Each is 0 to 4 with 0 being never and 4 being almost always. The total scale score, the mean is computed as the sum of all the items over the number of items answered on all the scales. The difference between pre and post QOL scores. Total scale score consists of 4 dimensions, physical, emotional, social, and school functioning. Scores are transformed on a scale from 0-100. The greater the score the better the quality of life. | Baseline and 8 weeks |
| PDGF-BB Levels (Platelet Derived Growth Factor) | Changes in PDGF-BB (Platelet Derived Growth Factor) levels in plasma from pre to post intervention. | Baseline (T1=week 6) and T2=week 14 |
| NGF (Nerve Growth Factor) | Change in NGF (Nerve Growth Factor) in plasma from pre to post intervention. | Baseline (T1=week 6) and T2=week 14 |
| Quality of Life as a Result in Changes in Neuropathy Scores. | Analyzing the correlation of changes in quality of life scores with neuropathy scores using Pearson's correlation coefficient. | 8 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Neuropathy | Total Neuropathy Score Pediatric Version; Range for each subscale is 0 to 4 with 0 being normal and 4 being the worst neuropathy. The total range is 0-36. | Mean | Inter-Quartile Range | units on a scale |
|
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| Primary | Acceptability - Parent Satisfaction Survey | Parents will also be asked to complete a satisfaction survey regarding the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items. Scores were on a Likert scale 1-5, 1 - strongly disagree and 5 - strongly agree. The total range is 13-65 with 65 being the greatest satisfaction possible and 13 being the worst satisfaction possible. | Any parent or caregiver with a child involved in the study. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
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| Secondary | Acceptability - Patient Satisfaction Survey | Patients will provide feedback on the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items. The scale is 1-5 with 1 - strongly disagree and 5 - strongly agree. The total range is 13-65 with 65 being the greatest satisfaction possible and 13 being the worst satisfaction possible. | Patients over the age of 5. Scores were averaged from Likert scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Pediatric Neuropathy | Total Neuropathy Score Pediatric Version; Range for each subscale is 0 to 4 with 0 being normal and 4 being the worst neuropathy. The total range is 0-36. 0 being no neuropathy. 36 being highest neuropathy possible. | Posted | Mean | Inter-Quartile Range | score on a scale | 8 weeks |
|
|
|
| Secondary | Quality of Life - Changes in Quality of Life From Pre Intervention to Post Intervention a Total of 8 Weeks. | Quality of Life: Pediatric Quality of Life Inventory; Each is 0 to 4 with 0 being never and 4 being almost always. The total scale score, the mean is computed as the sum of all the items over the number of items answered on all the scales. The difference between pre and post QOL scores. Total scale score consists of 4 dimensions, physical, emotional, social, and school functioning. Scores are transformed on a scale from 0-100. The greater the score the better the quality of life. | The difference between pre and post intervention score is the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
|
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| Secondary | PDGF-BB Levels (Platelet Derived Growth Factor) | Changes in PDGF-BB (Platelet Derived Growth Factor) levels in plasma from pre to post intervention. | Posted | Mean | Standard Deviation | percentage of baseline | Baseline (T1=week 6) and T2=week 14 |
|
|
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| Secondary | NGF (Nerve Growth Factor) | Change in NGF (Nerve Growth Factor) in plasma from pre to post intervention. | Posted | Mean | Standard Deviation | percentage of baseline NGF | Baseline (T1=week 6) and T2=week 14 |
|
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| Secondary | Quality of Life as a Result in Changes in Neuropathy Scores. | Analyzing the correlation of changes in quality of life scores with neuropathy scores using Pearson's correlation coefficient. | Changes in neuropathy scores as correlated with quality of life scores. | Posted | Number | Pearson's correlation coefficient | 8 weeks |
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| 0 |
| 10 |
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| 10 |
| 0 |
| 10 |
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