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Physical Activity, Fatigue, Sleep, and Inflammation (ABLE)

2016년 3월 7일 업데이트: University of Alabama at Birmingham

Physical Activity Benefits After Breast Cancer: Exploring Cytokine Mechanisms

The purpose of the study is to examine the benefits of physical activity for breast cancer survivors related to muscle strength, tiredness, and sleep quality. Also, the study will determine the potential role of inflammation in these benefits.

연구 개요

상태

완전한

정황

상세 설명

Our previous research has shown that increases in physical activity can improve the health and well-being of breast cancer survivors. The current study will determine whether the physical activity increases are adequate for improved health by measuring physical activity (accelerometer and self-report), muscle strength, fatigue, and sleep. Moreover, few studies have examined cytokine changes in cancer survivors after participation in a physical activity behavior change intervention with a mechanistic focus on cytokines which may influence the muscle strength, fatigue, and sleep response to the intervention.

Seventy-four female, breast cancer survivors are being recruited within a 50-miles radius of Springfield, IL. Participants will be in the study for approximately 5 months. Participants will be asked to complete a questionnaire at the beginning of the study and 3 months later. A blood sample will be drawn to determine serum cytokine levels.

Volunteers will be randomly assigned to 1 of 2 study groups. The intervention group will participate in a 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands.

This randomized controlled trial includes the following study aims:

Study aim 1: The intervention group will be compared with the control group to examine the change in physical activity, muscle strength, fatigue, and sleep dysfunction before and after participation in a physical activity intervention.

Study aim 2: To investigate mechanisms that may underlie the effects of the physical activity intervention on muscle strength, fatigue, and sleep, we will compare the intervention group with the control group in terms of changes in cytokine markers of inflammation and evaluate whether such changes are consistent with and may mediate changes in muscle strength, fatigue, and sleep dysfunction.

연구 유형

중재적

등록 (실제)

49

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • Illinois
      • Springfield, Illinois, 미국, 62702
        • Southern Illinois University School of Medicine

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

30년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Female, 30 to 70 years of age, with first diagnosis of ductal carcinoma in situ (DCIS) or Stage I or Stage II breast cancer
  • If chemotherapy or radiation therapy was received, the patient must be at least 4 weeks status post final primary treatment administration to allow treatment related cytokine changes to resolve. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
  • If the patient has undergone a surgical procedure, she must be at least 8 weeks post-procedure.
  • English speaking
  • Medical clearance for participation provided by primary care physician or oncologist
  • Postmenopausal
  • Average fatigue over the past week of ≥ 3 on a 1 to 10 Likert scale or sleep dysfunction ≥ 1 on a 0 to 3 Likert scale
  • Participating, on average, in no more than 20 minutes of physical activity on two or fewer days per week during the past six months
  • Willing to abstain from "as needed" medications for 7 days prior to each blood draw. "As needed" medications are defined as any medicine (prescription or over-the-counter) that is taken sporadically as needed for specific complaints rather than taken at regularly scheduled intervals (e.g., daily).

Exclusion Criteria:

  • Metastatic or recurrent breast cancer
  • Inability to ambulate without assistance
  • Unstable angina
  • New York Heart Association class II, III, or IV congestive heart failure
  • Uncontrolled asthma
  • Interstitial lung disease
  • Current use of steroids
  • Having been told by a physician to only do exercise prescribed by a physician
  • Dementia or organic brain syndrome
  • Schizophrenia or active psychosis
  • Connective tissue or rheumatologic disease [i.e., Systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, progressive systemic sclerosis, CREST syndrome, polymyositis, dermatomyositis, vasculitis, polymyalgia rheumatic, temporal arteritis]
  • Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
  • Do not live or work less than 50 miles from the study site
  • Lack of transportation to the study site
  • Changes in usual medications expected during the study time period
  • Plan to move residence out of the local area during the 5 months of the study
  • Plan to travel out of the local area for vacation during the first 4 weeks of the intervention or plan to travel out of the local area for more than a week during the last 8 weeks of the intervention
  • Contraindication to participation in physical activity (i.e., moderate intensity walking and strength training with resistance bands)

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control
no physical activity intervention
실험적: Exercise intervention
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
다른 이름들:
  • 행사

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
physical activity
기간: baseline and 3 months
The intervention group will be compared with the control group to examine the change in physical activity, before and after participation in a physical activity intervention. Participants are in the study for approximately 5 months. Assessments will be conducted at baseline, and following the 3 month exercise intervention.
baseline and 3 months
muscle strength
기간: baseline and 3 months
The intervention group will be compared with the control group to examine the change in muscle strength before and after participation in a physical activity intervention.
baseline and 3 months
fatigue
기간: baseline and 3 months
The intervention group will be compared with the control group to examine the change in fatigue before and after participation in a physical activity intervention.
baseline and 3 months
sleep dysfunction
기간: baseline and 3 months
The intervention group will be compared with the control group to examine the change in sleep dysfunction before and after participation in a physical activity intervention.
baseline and 3 months

2차 결과 측정

결과 측정
측정값 설명
기간
inflammatory markers (serum cytokine levels)
기간: baseline and 3 months
The study will also examine whether changes in inflammatory markers mediate improvements in the outcome measures of muscle strength, fatigue, and sleep dysfunction. Blood samples with no potential for extraction of DNA will be collected.
baseline and 3 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

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

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

2010년 8월 1일

기본 완료 (실제)

2013년 12월 1일

연구 완료 (실제)

2013년 12월 1일

연구 등록 날짜

최초 제출

2010년 6월 17일

QC 기준을 충족하는 최초 제출

2010년 6월 17일

처음 게시됨 (추정)

2010년 6월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 3월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 3월 7일

마지막으로 확인됨

2016년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • ROG-SCCI-10-004-1
  • R21CA135017-01A2 (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. .

유방암에 대한 임상 시험

3 month physical activity intervention에 대한 임상 시험

3
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