Motor Proficiency And Physical Activity in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
26 août 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
807
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Tennessee
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Memphis, Tennessee, États-Unis, 38105
- St. Jude Children's Research Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Transversale
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Ascertain the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL.
Délai: Day 1-2
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Day 1-2
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group.
Délai: 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.
Délai: 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.
Délai: Day 1-7
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Day 1-7
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2009
Achèvement primaire (Réel)
1 avril 2013
Achèvement de l'étude (Réel)
1 avril 2013
Dates d'inscription aux études
Première soumission
8 janvier 2010
Première soumission répondant aux critères de contrôle qualité
11 janvier 2010
Première publication (Estimation)
12 janvier 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 août 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2015
Dernière vérification
1 août 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MTRPAL
- R01CA132901 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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