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Motor Proficiency And Physical Activity in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

2015년 8월 26일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

The study will focus on the following primary objectives:

  1. 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.

  2. 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:

  1. 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.
  2. 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.
  3. 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.

연구 유형

관찰

등록 (실제)

807

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Tennessee
      • Memphis, Tennessee, 미국, 38105
        • St. Jude Children's Research Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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.

설명

Inclusion Criteria:(ALL survivors):

  1. Research participant who is a survivor of childhood ALL who was treated at St. Jude Children's Research Hospital between 1980 and 1999
  2. Research participant must be at least ten years from diagnosis
  3. Research participant must be at least 18 years of age at the time of the scheduled evaluation

Exclusion Criteria (ALL survivors):

  1. Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function
  2. Research participant currently pregnant or lactating
  3. Research participant age 17 years or less
  4. Research participant undergoing active treatment for cancer

Inclusion Criteria (Comparison Group)

  1. Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient.
  2. Research participant must be at least 18 years of age at the time of the scheduled evaluation

Exclusion Criteria (Comparison Group)

  1. Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function
  2. Research participant currently pregnant or lactating
  3. Research participant age 17 years or less
  4. Research participant has a medical history of cancer
  5. Research participant is a first degree relative of a survivor participating in MTRPAL

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 케이스 컨트롤
  • 시간 관점: 단면

코호트 및 개입

그룹/코호트
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
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Ascertain the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL.
기간: Day 1-2
Day 1-2

2차 결과 측정

결과 측정
기간
Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group.
기간: Day 1-7
Day 1-7
Describe the association between habitual physical activity and energy expenditure among ALL survivors.
기간: Day 1-7
Day 1-7
Explore the associations between musculoskeletal and sensory health, and physical activity patterns among adult survivors of childhood ALL.
기간: Day 1-7
Day 1-7

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

St. Jude Children's Research Hospital

협력자

National Cancer Institute (NCI)
University of Pittsburgh
University of Tennessee

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 6월 1일

기본 완료 (실제)

2013년 4월 1일

연구 완료 (실제)

2013년 4월 1일

연구 등록 날짜

최초 제출

2010년 1월 8일

QC 기준을 충족하는 최초 제출

2010년 1월 11일

처음 게시됨 (추정)

2010년 1월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 8월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 8월 26일

마지막으로 확인됨

2013년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MTRPAL
  • R01CA132901 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다