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临床试验/NCT01984060
NCT01984060已完成不适用

Feasibility of an Exercise Intervention In HIV+ Older Adults

University of Rochester1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2013年12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
74
试验地点
1
主要终点
Change in Feasibility

研究概览

简要总结

The overall purpose of this research is to evaluate the effect of a home-based exercise program on physical function and to improve the health and quality of life for the HIV-infected older adult community.

详细描述

Subjects are being asked to participate in this study if they are infected with the human immunodeficiency virus (HIV), and they are 45 years of age or older.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •HIV positive, both genders, all races, English speaking individuals, age 45 years or older, on HAART before enrollment. .

排除标准

  • •Subject will be excluded if he/she has history or currently has severe cardiopulmonary illness, severe orthopedic or neuromuscular impairments, significant cognitive or sensory impairments, history of active malignancy, untreated depression, manic or psychotic disorder, and normal PPT score.

研究组 & 干预措施

HOME-EX

Other

Motivational Counseling: Six patient-centered motivational counseling sessions based on the self-determination theory (SDT) of behavior change will be conducted with the patients in the HOME-EX group over 12 weeks.

Exercise Intervention: an individually tailored home-based exercise program performed 5-7 days a week that consists of walking prescription, and individualized strength training exercise designed to provide moderately intense progressive resistance exercise. Subjects will be given a set of 3 color-coded therapeutic resistance bands representing varying levels of resistance and they will start with a number of sets which is customized for each individual and they will be encouraged to progressively increase from their individual baseline sets.

干预措施: HOME-EX (Other)

Control

No Intervention

Subjects are instructed to maintain their usual activities during the study period. This group did not receive any PA counseling or recommendations.

结局指标

主要结局

Change in Feasibility

时间窗: At day zero of the study and after 12 weeks of intervension.

To develop and establish the feasibility of home-exercise(HOME-EX)in HIV positive subjects as evaluated by measuring exercise adherence and acceptability, exercise intensity and adverse events. We hypothesize that HOME-EX is a feasible and safe intervention for HOA.

次要结局

  • Change in Autonomy(At day zero of the study and after 12 weeks of intervension.)
  • Change in Efficacy(At day zero of the study and after 12 weeks of intervension.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Krupa Shah

M.D. Assistant professor

University of Rochester

研究点 (1)

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