NCT02611219已完成1 期
Effect of Increased Activity on Deconditioning in Pediatric Stem Cell Transplant Recipients: A Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quality of life as measured by General Health Module questionnaires
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(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
研究组 & 干预措施
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: General Health Module-Baseline Adolescent-Self Report (13-18 years) (Other)
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: General Health Module-Follow Up Adolescent-Self Report (13-18 years) (Other)
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: Demographic Data Form (Other)
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: SCT Daily Activity Log (Other)
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: The Functional Independence Measure for Children (Other)
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: Manual Muscle Testing (Other)
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: 3-Minute Step Test (Other)
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: HSCT Module-Follow Up Adolescent-Self Report (13-18 years) (Other)
Arm 1: Pediatric patients
Experimental
- 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.
干预措施: HSCT Module-Follow Child-Self Report (5-12 years) (Other)
Arm 2: Parents of pediatric patients
Experimental
- 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
干预措施: General Health Module-Baseline Parent Report-Adolescent (13-18 years) (Other)
Arm 2: Parents of pediatric patients
Experimental
- 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
干预措施: General Health Module-Follow Up Parent Report-Adolescent (13-18 years) (Other)
Arm 2: Parents of pediatric patients
Experimental
- 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
干预措施: General Health Module-Baseline Parent Report-School Age (5-12 years) (Other)
Arm 2: Parents of pediatric patients
Experimental
- 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
干预措施: General Health Module-Follow Up Parent Report-School Age (5-12 years) (Other)
Arm 2: Parents of pediatric patients
Experimental
- 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
干预措施: Demographic Data Form (Other)
Arm 2: Parents of pediatric patients
Experimental
- 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
干预措施: SCT Daily Activity Log (Other)
Arm 2: Parents of pediatric patients
Experimental
- 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
干预措施: HSCT Module-Follow Up Parent Report-adolescent (13-18 years) (Other)
Arm 2: Parents of pediatric patients
Experimental
- 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
干预措施: HSCT Module-Follow Up Parent Report-School Age (5-12 years) (Other)
结局指标
主要结局
Quality of life as measured by General Health Module questionnaires
时间窗: Baseline through 6 week clinic visit (up to an estimated 82 days)
Recruitment and retention of participants throughout the study
时间窗: 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
时间窗: Baseline through 6 week clinic visit (up to an estimated 82 days)
Quality of life as measured by General Health Module questionnaires
时间窗: Discharge from hospital (estimated to be 40 days)
次要结局
未报告次要终点
研究者
研究点 (1)
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