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临床试验/NCT02057536
NCT02057536已完成不适用

Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Pain Disability Index

研究概览

简要总结

The objective of this study is to determine if patients taking aromatase inhibitors (AI), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. The overarching objective is to improve patient compliance with the medication and ultimately clinical outcome.

In this pilot study, we will utilize a scientific approach for proof of concept employing both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and subjective (patient perception) methods to support an evidence based clinical plan. Patients will be divided into two cohorts. Group A will receive AI therapy with a directed exercise program. Group B will receive AI therapy without a directed exercise program. Data will be collected when both cohorts of patients enroll in the study, at the end of PT for Group A and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression scale, and pain level scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women over age 40 with histological evidence of hormone receptor positive breast cancer.
  • •Post- menopausal
  • •Adjuvant AI therapy.
  • •Significant joint discomfort/stiffness when attempting activities of daily living which began or significantly increased after initiation of AI therapy.
  • •Currently not in an active directed exercise program (>60 minutes 2x/wk)

排除标准

  • •Preexisting RA or fibromyalgia.
  • •Systemic metastasis
  • •ECOG performance status of greater than

研究组 & 干预措施

Arm A

Experimental

8 week directed exercise program

干预措施: Arm A Directed exercise program (Other)

Arm B

Active Comparator

No directed exercise other than patients normal level of activity

干预措施: Observation (Other)

结局指标

主要结局

Pain Disability Index

时间窗: 8 weeks

directed exercise program will improve patient response to the pain disability index survey.

次要结局

  • Plasma levels of inflammatory markers.(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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