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Deconditioning in Transplant

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ClinicalTrials.gov Identifier: NCT02611219
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Hematopoietic and Stem Cell Transplant Other: General Health Module-Baseline Adolescent-Self Report (13-18 years) Other: General Health Module-Follow Up Adolescent-Self Report (13-18 years) Other: General Health Module-Baseline Parent Report-Adolescent (13-18 years) Other: General Health Module-Follow Up Parent Report-Adolescent (13-18 years) Other: General Health Module-Baseline Parent Report-School Age (5-12 years) Other: General Health Module-Follow Up Parent Report-School Age (5-12 years) Other: Demographic Data Form Other: SCT Daily Activity Log Other: The Functional Independence Measure for Children Other: Manual Muscle Testing Other: 3-Minute Step Test Other: HSCT Module-Follow Up Adolescent-Self Report (13-18 years) Other: HSCT Module-Follow Child-Self Report (5-12 years) Other: HSCT Module-Follow Up Parent Report-adolescent (13-18 years) Other: HSCT Module-Follow Up Parent Report-School Age (5-12 years) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Increased Activity on Deconditioning in Pediatric Stem Cell Transplant Recipients: A Feasibility Study
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Arm 1: Pediatric patients
  • Patients will wear a Fitbit Flex during hospitalization
  • Completion of Demographic Data Form at baseline, discharge from hospital, and at the six week clinic visit
  • Assist in recording time out of bed using the SCT Daily Activity Log
  • Fill out (some with help of parents) applicable questionnaires: Child Health Ratings Inventories-General Health Module (5-12 years), General Health Module-Baseline Adolescent-Self Report (13-18 years), General Health Module-Follow Up Adolescent-Self Report (13-18 years) at baseline, discharge from hospital, and at six week clinic visit
  • Patients will be assessed using standard physical therapy assessment tools to determine functioning, muscle strength, endurance, and mobility: The Functional Independence Measure for Children and Manual Muscle Testing is done weekly, discharge from hospital, and at six week clinic visit. The 3-Minute Step Test is done at admission, discharge from hospital, and at six week clinic visit.
Other: General Health Module-Baseline Adolescent-Self Report (13-18 years)
  • 38 question questionnaire
  • Answers range from 1=all of the time to 5=none of the time

Other: General Health Module-Follow Up Adolescent-Self Report (13-18 years)
  • 38 question questionnaire about child
  • Answers range from 1=all of the time to 5=none of the time

Other: Demographic Data Form
-16 questions about demographics such as household income, race, and gender

Other: SCT Daily Activity Log
  • 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

Other: The Functional Independence Measure for Children
  • 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 Name: WeeFIM

Other: Manual Muscle Testing
-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 Name: MMT

Other: 3-Minute Step Test
  • 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

Other: HSCT Module-Follow Up Adolescent-Self Report (13-18 years)
  • 7 question questionnaire about child
  • Answers range from 1=all of the time to 5=none of the time

Other: HSCT Module-Follow Child-Self Report (5-12 years)
  • 10 question questionnaire about child
  • Answers range from 1=all of the time to 5=none of the time

Experimental: Arm 2: Parents of pediatric patients
  • Parents will be considered participants as they will be completing study questionnaires.
  • Completion of Demographic Data Form at baseline
  • Assist in recording time out of bed using the SCT Daily Activity Log
  • Fill out applicable questionnaires: 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), and General Health Module Follow Up Parent Report-School Age (5-12 years), HSCT Module-Follow UP Parent Report School Age (5-12 years), HSCT Module-Follow Up Parent Report Adolescent (13-18 years), HSCT Module-Follow Up Adolescent-Self Report (13-18 years), HSCT Module-Follow Child-Self Report (5-12 years) at baseline, discharge from hospital, and at six week clinic visit.
  • Assist child with Child Health Ratings Inventories-General Health Module (5-12 years) at baseline, discharge at hospital, and at six week clinic visit
Other: General Health Module-Baseline Parent Report-Adolescent (13-18 years)
  • 38 question questionnaire about child
  • 49 question questionnaire about parent
  • Answers range from 1-all of the time to 5=none of the time

Other: General Health Module-Follow Up Parent Report-Adolescent (13-18 years)
  • 38 question questionnaire about child
  • 49 question questionnaire about parent
  • Answers range from 1-all of the time to 5=none of the time

Other: General Health Module-Baseline Parent Report-School Age (5-12 years)
  • 34 question questionnaire about child
  • 49 question questionnaire about parent
  • Answers range from 1-all of the time to 5=none of the time

Other: General Health Module-Follow Up Parent Report-School Age (5-12 years)
  • 34 question questionnaire about child
  • 49 question questionnaire about parent
  • Answers range from 1-all of the time to 5=none of the time

Other: Demographic Data Form
-16 questions about demographics such as household income, race, and gender

Other: SCT Daily Activity Log
  • 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

Other: HSCT Module-Follow Up Parent Report-adolescent (13-18 years)
  • 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: HSCT Module-Follow Up Parent Report-School Age (5-12 years)
  • 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 Outcome Measures :
  1. 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

  2. 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) ]
  3. Quality of life as measured by General Health Module questionnaires [ Time Frame: Discharge from hospital (estimated to be 40 days) ]
  4. Quality of life as measured by General Health Module questionnaires [ Time Frame: Baseline through 6 week clinic visit (up to an estimated 82 days) ]


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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611219


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Heather Taylor, RN, BSN, CPHON Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02611219     History of Changes
Other Study ID Numbers: 201406031
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016