Deconditioning in Transplant

Early Phase 1

Completed

• Conditions: Hematopoietic and Stem Cell Transplant
• Interventions: Other: General Health Module-Baseline Adolescent-Self Report (13-18 years); Other: General Health Module-Baseline Parent Report-Adolescent (13-18 years); Other: General Health Module-Follow Up Adolescent-Self Report (13-18 years); Other: General Health Module-Follow Up Parent Report-Adolescent (13-18 years); Other: Demographic Data Form; Other: General Health Module-Baseline Parent Report-School Age (5-12 years); Other: SCT Daily Activity Log; Other: General Health Module-Follow Up Parent Report-School Age (5-12 years); Other: The Functional Independence Measure for Children; Other: Manual Muscle Testing; Other: 3-Minute Step Test; Other: HSCT Module-Follow Up Parent Report-adolescent (13-18 years); Other: HSCT Module-Follow Up Adolescent-Self Report (13-18 years); Other: HSCT Module-Follow Up Parent Report-School Age (5-12 years); Other: HSCT Module-Follow Child-Self Report (5-12 years)

• Registration Number: NCT02611219
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-11-12
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-26
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Pediatric patients	HSCT Module-Follow Up Adolescent-Self Report (13-18 years)	* 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.
Arm 1: Pediatric patients	HSCT Module-Follow Child-Self Report (5-12 years)	* 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.
Arm 1: Pediatric patients	General Health Module-Baseline Adolescent-Self Report (13-18 years)	* 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.
Arm 1: Pediatric patients	General Health Module-Follow Up Adolescent-Self Report (13-18 years)	* 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.
Arm 2: Parents of pediatric patients	General Health Module-Baseline Parent Report-Adolescent (13-18 years)	* 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
Arm 1: Pediatric patients	Demographic Data Form	* 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.
Arm 1: Pediatric patients	SCT Daily Activity Log	* 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.
Arm 1: Pediatric patients	The Functional Independence Measure for Children	* 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.
Arm 1: Pediatric patients	Manual Muscle Testing	* 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.
Arm 1: Pediatric patients	3-Minute Step Test	* 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.
Arm 2: Parents of pediatric patients	General Health Module-Follow Up Parent Report-Adolescent (13-18 years)	* 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
Arm 2: Parents of pediatric patients	General Health Module-Follow Up Parent Report-School Age (5-12 years)	* 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
Arm 2: Parents of pediatric patients	General Health Module-Baseline Parent Report-School Age (5-12 years)	* 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
Arm 2: Parents of pediatric patients	SCT Daily Activity Log	* 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
Arm 2: Parents of pediatric patients	HSCT Module-Follow Up Parent Report-adolescent (13-18 years)	* 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
Arm 2: Parents of pediatric patients	HSCT Module-Follow Up Parent Report-School Age (5-12 years)	* 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
Arm 2: Parents of pediatric patients	Demographic Data Form	* 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

Primary Outcome Measures

Name	Time	Method
Quality of life as measured by General Health Module questionnaires	Baseline through 6 week clinic visit (up to an estimated 82 days)
Recruitment and retention of participants throughout the study	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	Baseline through 6 week clinic visit (up to an estimated 82 days)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States