Washington University School of Medicine
St Louis, Missouri, 63110, United States
Completed
NCT Number: NCT02611219
Deconditioning in Transplant
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.
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Conditions
Age range
7 year–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Early Phase 1
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Pediatric Patients)
- Ages 7-17 years
- Admitted to hospital for stem cell transplant
- Speaks English
Inclusion criteria
(Parents of pediatric patients)
- Parents of children ages 7-17 years
- Parents of children admitted to hospital for stem cell transplant
- Speaks English
Exclusion criteria
(Pediatric Patients) -Admitted to transplant unit for autologous stem cell transplant, donor lymphocyte infusions, mesenchymal cell infusions, a second stem cell transplant, graft versus host disease or other complications post stem cell transplant will not be included
Exclusion criteria
(Parents of pediatric patients)
-Parents of children admitted to transplant unit for autologous stem cell transplant, donor lymphocyte infusions, mesenchymal cell infusions, a second stem cell transplant, graft versus host disease or other complications post stem cell transplant will not be included
Treatment and study plan
General Health Module-Baseline Adolescent-Self Report (13-18 years)
Other- 38 question questionnaire
- Answers range from 1=all of the time to 5=none of the time
General Health Module-Follow Up Adolescent-Self Report (13-18 years)
Other- 38 question questionnaire about child
- Answers range from 1=all of the time to 5=none of the time
General Health Module-Baseline Parent Report-Adolescent (13-18 years)
Other- 38 question questionnaire about child
- 49 question questionnaire about parent
- Answers range from 1-all of the time to 5=none of the time
General Health Module-Follow Up Parent Report-Adolescent (13-18 years)
Other- 38 question questionnaire about child
- 49 question questionnaire about parent
- Answers range from 1-all of the time to 5=none of the time
General Health Module-Baseline Parent Report-School Age (5-12 years)
Other- 34 question questionnaire about child
- 49 question questionnaire about parent
- Answers range from 1-all of the time to 5=none of the time
General Health Module-Follow Up Parent Report-School Age (5-12 years)
Other- 34 question questionnaire about child
- 49 question questionnaire about parent
- Answers range from 1-all of the time to 5=none of the time
Demographic Data Form
Other-16 questions about demographics such as household income, race, and gender
SCT Daily Activity Log
Other- 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
The Functional Independence Measure for Children
Other- 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.
Other names: WeeFIM
Manual Muscle Testing
Other-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.
Other names: MMT
3-Minute Step Test
Other- 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
HSCT Module-Follow Up Adolescent-Self Report (13-18 years)
Other- 7 question questionnaire about child
- Answers range from 1=all of the time to 5=none of the time
HSCT Module-Follow Child-Self Report (5-12 years)
Other- 10 question questionnaire about child
- Answers range from 1=all of the time to 5=none of the time
HSCT Module-Follow Up Parent Report-adolescent (13-18 years)
Other- 7 question questionnaire about child
- 49 question questionnaire about parent
- Answers range from 1=all of the time to 5=none of the time
HSCT Module-Follow Up Parent Report-School Age (5-12 years)
Other- 7 question questionnaire about child
- 49 question questionnaire about parent
- Answers range from 1=all of the time to 5=none of the time
Primary outcomes
-
Recruitment and retention of participants throughout the study
Time frame: Baseline through 6 week clinic visit (up to an estimated 82 days)
-Analyze the number of participants enrolled who continue through the 6 week clinic visit
-
Number of participants who achieve 6 hours out of bed through the 6 week clinic visit
Time frame: Baseline through 6 week clinic visit (up to an estimated 82 days)
-
Quality of life as measured by General Health Module questionnaires
Time frame: Discharge from hospital (estimated to be 40 days)
-
Quality of life as measured by General Health Module questionnaires
Time frame: Baseline through 6 week clinic visit (up to an estimated 82 days)
Sponsors and collaborators
Lead sponsor
Washington University School of Medicine
Other
Registry information
Official study title
Effect of Increased Activity on Deconditioning in Pediatric Stem Cell Transplant Recipients: A Feasibility Study
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Nov 20, 2015
- Registry last updated
- May 27, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.