Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percent completion of the prescribed aerobic exercise intervention
研究概览
简要总结
Depression in people living with HIV is associated with worse care engagement, drug adherence, and higher rates of pre-mature mortality. The prevalence of depression is three times greater in those with HIV than comparable controls. While antiretroviral therapy (ART) enables immune reconstitution, those with depression do worse clinically than those without depression even when controlling for HIV stage. However, treating depression in HIV-infected persons is challenging. Even among those virologically suppressed on ART, a significant percentage are resistant to standard pharmacotherapy or psychotherapy for depression. The reasons for this are complex and poorly understood. An emerging body of evidence indicates that inflammation may perpetuate depression. Given people with HIV have ongoing increased inflammation, this could help explain part of why depression rates are so high in people with HIV.
Treatments for HIV-associated depression would likely be more effective if they were anti- inflammatory in nature. One possible treatment is exercise. Exercise is acutely pro-inflammatory due to catabolism but in the long term is anti-inflammatory. However, few studies have investigated exercise as a treatment for HIV-associated depression. The study objective is to perform a feasibility study to evaluate a larger trial evaluating the efficacy of exercise as an intervention for depression in people with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in Mildmay HIV clinic
- •Adults 18-45 years old
- •HIV positive
- •Receiving HIV therapy
- •HIV viral suppression (<400 copies/mL) per chart review
- •Mild to Moderate (PHQ9 score >5 but >20)
- •Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking
- •Able to walk/run on a treadmill
- •Informed consent
排除标准
- •Women pregnant or breastfeeding
- •Suicidal (PHQ-9 question 9 score >2) or Severely Depressed (PHQ-9 score >20)
- •Uncontrolled hypertension (≥180 systolic or ≥100 diastolic blood pressure)
- •Lower limb orthopedic limitations (e.g. amputations, arthritis)
- •Resting heart rate >90/min
- •Known atherosclerotic or non-atherosclerotic peripheral artery disease.
- •Exercise intolerance due to other known medical condition(s) which may make it unsafe for the patients to participate in.
结局指标
主要结局
Percent completion of the prescribed aerobic exercise intervention
时间窗: 8 weeks
assessed by research staff logging participation
次要结局
- power estimate(baseline and 8 weeks)
- depression score(baseline and 8 weeks)
- acceptability of the intervention(8 weeks)
- feasibility of using a wearable exercise tracker 2(8 weeks)
- feasibility of using a wearable exercise tracker 1(8 weeks)
- effect size for a future intervention(Baseline and 8 weeks)
- effect size(baseline and 8 weeks)
- aerobic fitness(Baseline and 8 weeks)
