Motor Proficiency And Physical Activity in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
26 agosto 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Effettivo)
807
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38105
- St. Jude Children's Research Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Ascertain the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL.
Lasso di tempo: Day 1-2
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Day 1-2
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: Day 1-7
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Day 1-7
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2009
Completamento primario (Effettivo)
1 aprile 2013
Completamento dello studio (Effettivo)
1 aprile 2013
Date di iscrizione allo studio
Primo inviato
8 gennaio 2010
Primo inviato che soddisfa i criteri di controllo qualità
11 gennaio 2010
Primo Inserito (Stima)
12 gennaio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 agosto 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 agosto 2015
Ultimo verificato
1 agosto 2013
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MTRPAL
- R01CA132901 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .