NCT03708640已完成不适用
A Prospective Randomized Pilot Study to Evaluate the Effect of a Mobile Health Physical Activity Intervention for HIV-associated Frailty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Mean daily step count
研究概览
简要总结
This pilot study will examine the effect of a mobile health text messaging platform linked to a digital physical activity tracker on physical activity among persons living with HIV and frailty.
详细描述
HIV is associated with frailty, an important aging-related phenotype associated with adverse clinical outcomes. The investigators propose that personalized health coaching using a digital activity tracker with mobile health text messaging can increase physical activity in this population. The total duration of the intervention will be 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-1 positive adults of any gender
- •Age 50 years and older
- •Frailty score of 2 or greater (at least 1 criteria is slow gait speed or decreased grip strength)
- •Ability to provide informed consent
排除标准
- •Any physical condition that would prevent or prohibit moderate physical activity
- •>3 days per week of moderate or vigorous leisure time activity lasting >30 min/day
结局指标
主要结局
Change in Mean daily step count
时间窗: Baseline, 12 weeks
Mean daily step count will be assessed using a digital physical activity tracker
次要结局
- Change in Frailty as assessed by the Fried-based physical frailty phenotype(Baseline, 12 weeks)
- Percent change in lean mass(Baseline, 12 weeks)
- Change in Muscle strength as assessed by isokinetic resistance(Baseline, 12 weeks)
- Percent change in fat mass(Baseline, 12 weeks)
- Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1)(Baseline, 12 weeks)
- Change in Physical Fitness as assessed by 12 minute walk(Baseline, 12 weeks)
- Change in Interleukin-6 (IL-6) concentration(Baseline, 12 weeks)
- Change in Physical performance as assessed by the physical performance battery(Baseline, 12 weeks)
- Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)(Baseline, 12 weeks)
研究者
研究点 (2)
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