Motor Proficiency And Physical Activity in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
26 de agosto de 2015 atualizado por: St. Jude Children's Research Hospital
Motor Proficiency And Physical Activity in Adult Survivors of Childhood ALL
The primary goal of this study is to provide comprehensive and objective information on impairments of musculoskeletal health, sensory function, and fitness among a large group of childhood ALL survivors, and to define high risk groups by assessing treatment factors that contribute to impaired function.
This study includes a direct, objective evaluation of musculoskeletal function, sensory capacity, fitness, and physical activity patterns among adults who were treated for childhood ALL at St. Jude Children's Research Hospital (SJCRH) between 1980 and 1999.
Among 899 ALL survivors, all of whom are eligible for an institutionally funded clinical study of medical late effects, the study will recruit 364 to participate in our evaluations.
The study will also recruit 364 individuals for a comparison group, frequency matching on race/ethnicity, age and gender.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The study will focus on the following primary objectives:
- Enumerate the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL. The study hypothesizes that adult survivors of childhood ALL will have a higher prevalence of musculoskeletal, sensory and fitness impairments than a control group frequency matched on race/ethnicity, age, and gender.
Evaluate the association between personal and treatment factors and musculoskeletal, sensory and fitness impairments. The study hypothesizes that:
- Female gender, younger age at diagnosis, and cranial radiation will be associated with decreased lean body mass.
- Female gender, younger age at diagnosis, and type of glucocorticoid (dexamethasone vs. prednisone) treatment will be associated with muscle weakness.
- Sensory loss will vary as a function of age, with participants diagnosed at 12+ years of age demonstrating vincristine related sensory loss, and those diagnosed at <12 years of age demonstrating dexamethasone and/or intrathecal methotrexate related sensory loss.
- Fitness impairments will be evident in participants who received 100 mg/m2+ of anthracyclines.
The study will focus on the secondary objectives:
- Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group. The study hypothesizes that adult survivors of childhood ALL will demonstrate lower levels of physical activity as measured with an activity monitor (accelerometer), and will report lower levels of overall physical activity, when compared to members of the comparison group.
- Describe the association between habitual physical activity and energy expenditure among ALL survivors. The study hypothesizes that activity levels, measured with the accelerometer, will be positively correlated with energy expenditure, measured using the doubly labeled water technique.
- Explore the associations between musculoskeletal and sensory health, and physical activity patterns among adult survivors of childhood ALL. The study hypothesizes that adult survivors of childhood ALL with lower proportions of lean muscle mass and/or sensory loss indicating peripheral neuropathy will demonstrate the lowest levels of physical activity.
Tipo de estudo
Observacional
Inscrição (Real)
807
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
The study sample for this research will be recruited from participants in an institutionally funded cohort study, St. Jude Life, as well as from active ACT patients that meet eligibility criteria.
The young adults in St. Jude Life are a highly motivated group who were followed in the After Completion of Therapy Clinic until age 18 years and a minimum of 10 years after their treatment ended if they were older than age 11 at the end of therapy.
Potentially eligible comparison group participants will be recruited from the parent, older sibling, relative or friend population who accompany the ACT patient for follow-up at SJCRH.
Parents (or siblings, relatives or friends who are 18 years or older) of children in remission, both from the active follow-up cohort (within five years of last treatment) and the After Completion of Therapy (ACT) cohort will be invited to complete the same assessments that the ALL survivor participants will complete.
Descrição
Inclusion Criteria:(ALL survivors):
- Research participant who is a survivor of childhood ALL who was treated at St. Jude Children's Research Hospital between 1980 and 1999
- Research participant must be at least ten years from diagnosis
- Research participant must be at least 18 years of age at the time of the scheduled evaluation
Exclusion Criteria (ALL survivors):
- Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function
- Research participant currently pregnant or lactating
- Research participant age 17 years or less
- Research participant undergoing active treatment for cancer
Inclusion Criteria (Comparison Group)
- Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient.
- Research participant must be at least 18 years of age at the time of the scheduled evaluation
Exclusion Criteria (Comparison Group)
- Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function
- Research participant currently pregnant or lactating
- Research participant age 17 years or less
- Research participant has a medical history of cancer
- Research participant is a first degree relative of a survivor participating in MTRPAL
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Transversal
Coortes e Intervenções
Grupo / Coorte |
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ALL survivors
The study sample for this research will be recruited from participants in an institutionally funded cohort study, St. Jude Life, as well as from active ACT patients that meet eligibility criteria.
The young adults in St. Jude Life are a highly motivated group who were followed in the After Completion of Therapy Clinic until age 18 years and a minimum of 10 years after their treatment ended if they were older than age 11 at the end of therapy
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Comparison Group
Potentially eligible comparison group participants will be recruited from the parent, older sibling, relative or friend population who accompany the ACT patient for follow-up at SJCRH.
Parents (or siblings, relatives or friends who are 18 years or older) of children in remission, both from the active follow-up cohort (within five years of last treatment) and the After Completion of Therapy (ACT) cohort will be invited to complete the same assessments that the ALL survivor participants will complete.
Comparison group participants are frequency matched to potentially eligible participants by race/ethnicity (white, black, other) age group (18 to 29, 30-39, 40-49 years) and gender.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Ascertain the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL.
Prazo: Day 1-2
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Day 1-2
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group.
Prazo: Day 1-7
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Day 1-7
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Describe the association between habitual physical activity and energy expenditure among ALL survivors.
Prazo: Day 1-7
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Day 1-7
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Explore the associations between musculoskeletal and sensory health, and physical activity patterns among adult survivors of childhood ALL.
Prazo: Day 1-7
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Day 1-7
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2009
Conclusão Primária (Real)
1 de abril de 2013
Conclusão do estudo (Real)
1 de abril de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
8 de janeiro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de janeiro de 2010
Primeira postagem (Estimativa)
12 de janeiro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
27 de agosto de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de agosto de 2015
Última verificação
1 de agosto de 2013
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MTRPAL
- R01CA132901 (Concessão/Contrato do NIH dos EUA)
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