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临床试验/NCT02794415
NCT02794415已完成不适用

Translating Exercise Into the HIV Community: Evaluating a Community-based Exercise Intervention to Improve the Health of Adults Living With HIV

University of Toronto2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Maximum oxygen consumption (VO2max)

研究概览

简要总结

The primary aim of this research is to evaluate a community-based exercise (CBE) intervention for adults living with HIV within the community with the goal of reducing disability and enhancing health (cardiopulmonary, strength, weight and body composition, and neurocognitive outcomes) and contextual factor outcomes (social support, stigma, mastery, coping) for adults living with HIV.

详细描述

Investigators will use the RE-AIM Framework to evaluate the community-based exercise (CBE) intervention. The RE-AIM Framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational-levels in order to promote uptake, transferability and ultimately enhance the public health impact of health promotion interventions.

Specific study objectives are: 1) To determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults with HIV participate in a CBE intervention; 2) To assess the effect of a CBE intervention on disability and health outcomes and intrinsic and extrinsic factor outcomes for people living with HIV; 3) To assess engagement in CBE for adults with HIV over time (adherence, level of physical activity); and 4) To evaluate the process (strengths and challenges; feasibility; accessibility, long term sustainability) of implementing a CBE intervention within the community from the perspective of recreation providers (fitness instructors; managers) and people living with HIV.

Investigators will conduct a prospective longitudinal study using mixed methods to evaluate a CBE intervention in the community with people living with HIV. They will use an interrupted time series (ITS) design in combination with qualitative interviews to assess outcomes at baseline (pre-testing phase), during (intervention phase) and after the CBE intervention (post-testing phase) to evaluate the short- and long-term effect of CBE.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18 years and older) living with HIV in Toronto who consider themselves medically stable and safe to engage in exercise and who are willing to participate in a 22 month study involving a 14 month CBE intervention at the YMCA.

排除标准

  • Not applicable.

结局指标

主要结局

Maximum oxygen consumption (VO2max)

时间窗: Bimonthly outcome assessment throughout baseline monitoring (8 months), intervention (6 months) and follow-up (8 months) for a total of 22 months

Maximum oxygen consumption (VO2max) ml/kg/min

次要结局

未报告次要终点

研究者

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

Kelly O'Brien

Associate Professor

University of Toronto

研究点 (2)

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