Deconditioning in Transplant
Condition: Hematopoietic and Stem Cell Transplant
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this feasibility study is to test the potential for successful implementation
      of an intervention designed to study the effect of six hours out of bed time on the overall
      level of deconditioning in pediatric stem cell transplant (SCT) patients. Previous research
      has demonstrated that deconditioning occurs rapidly over the course of the hospitalization
      post-transplant and can negatively impact quality of life. By encouraging patients to be out
      of bed for six hours each day, it is anticipated that patients will experience less
      deconditioning than those patients who previously had no established minimum time out of the
      bed.
    


Intervention name(s): General Health Module-Baseline Adolescent-Self Report (13-18 years); General Health Module-Follow Up Adolescent-Self Report (13-18 years); General Health Module-Baseline Parent Report-Adolescent (13-18 years); General Health Module-Follow Up Parent Report-Adolescent (13-18 years); General Health Module-Baseline Parent Report-School Age (5-12 years); General Health Module-Follow Up Parent Report-School Age (5-12 years); Demographic Data Form; SCT Daily Activity Log; The Functional Independence Measure for Children; Manual Muscle Testing; 3-Minute Step Test; HSCT Module-Follow Up Adolescent-Self Report (13-18 years); HSCT Module-Follow Child-Self Report (5-12 years); HSCT Module-Follow Up Parent Report-adolescent (13-18 years); HSCT Module-Follow Up Parent Report-School Age (5-12 years)
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 38 question questionnaire
Answers range from 1=all of the time to 5=none of the time; 38 question questionnaire about child
Answers range from 1=all of the time to 5=none of the time; 38 question questionnaire about child
49 question questionnaire about parent
Answers range from 1-all of the time to 5=none of the time; 38 question questionnaire about child
49 question questionnaire about parent
Answers range from 1-all of the time to 5=none of the time; 34 question questionnaire about child
49 question questionnaire about parent
Answers range from 1-all of the time to 5=none of the time; 34 question questionnaire about child
49 question questionnaire about parent
Answers range from 1-all of the time to 5=none of the time; -16 questions about demographics such as household income, race, and gender; Uses Fitbit Flex
Log that lists time in 15 minute increments and allows for checking when out of bed and describing the activity that occurred while out of bed; 18-item, 7-level ordinal scale instrument that measures a child's consistent performance in essential daily functional skills. Three main domains (selfcare, mobility, and cognition) are assessed by interviewing or by observing a child's performance of a task to criterion standards
Categorized into 2 main functional streams: "Dependent" (ie, requires helper: scores 1-5) and "Independent" (ie, requires no helper: scores 6-7). Scores 1 (total assistance) and 2 (maximal assistance) belongs to the "Complete Dependence" category. Scores 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belongs to the "Modified Dependence" category. Scores 6 (modified independence) and 7 (complete independence) belongs to the "Independent" category.; -Isometric muscle strength is tested in specific positions, usually with the muscle at an optimal working length. Using a "break" test, the test giver overpowers the muscle being tested to determine the muscle grade.; Using an aerobic step, the participant walks up and down for a given amount of time with the heart rate being checked before and after
Using the difference in heart rate and a shortness of breath scale, this test is able to give an estimate of aerobic tolerance; 7 question questionnaire about child
Answers range from 1=all of the time to 5=none of the time; 10 question questionnaire about child
Answers range from 1=all of the time to 5=none of the time; 7 question questionnaire about child
49 question questionnaire about parent
Answers range from 1=all of the time to 5=none of the time; 7 question questionnaire about child
49 question questionnaire about parent
Answers range from 1=all of the time to 5=none of the time
Other intervention name(s): WeeFIM; MMT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care