Deconditioning in Transplant

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Hematopoietic and Stem Cell Transplant

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02611219

201406031

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm 1: Pediatric patients

Experimental group

Description:

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.

Treatment:

Other: SCT Daily Activity Log

Other: HSCT Module-Follow Child-Self Report (5-12 years)

Other: General Health Module-Follow Up Adolescent-Self Report (13-18 years)

Other: General Health Module-Baseline Adolescent-Self Report (13-18 years)

Other: Demographic Data Form

Other: HSCT Module-Follow Up Adolescent-Self Report (13-18 years)

Other: Manual Muscle Testing

Other: 3-Minute Step Test

Other: The Functional Independence Measure for Children

Arm 2: Parents of pediatric patients

Experimental group

Description:

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

Treatment:

Other: HSCT Module-Follow Up Parent Report-School Age (5-12 years)

Other: General Health Module-Baseline Parent Report-Adolescent (13-18 years)

Other: HSCT Module-Follow Up Parent Report-adolescent (13-18 years)

Other: SCT Daily Activity Log

Other: General Health Module-Follow Up Parent Report-Adolescent (13-18 years)

Other: Demographic Data Form

Other: General Health Module-Follow Up Parent Report-School Age (5-12 years)

Other: General Health Module-Baseline Parent Report-School Age (5-12 years)