Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Physical Performance
研究概览
简要总结
The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.
详细描述
The purpose of this pilot study is to test the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the UTMB hospital
- •Aged 65 years or older
- •Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization
- •Alert and oriented x3 by a physician on H&P.
- •Discharged "to home" at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay.
排除标准
- •A Nursing home resident or hospice care patient
- •Uncontrolled blood pressure (systolic >170, or diastolic > 100)
- •New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx)
- •End stage renal disease
- •AST/ALT 2.5 times above the normal limit
- •Recent (within 3 months) or current treatment with anabolic steroids.
- •History of breast or prostate cancer
- •Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml (PSA ≥ 3 ng/ml in men at high risk of prostate cancer)
- •Hematocrit ≥ 50%
- •Any other condition or event considered exclusionary by the PI and faculty physician
研究组 & 干预措施
Placebo
Placebo Supplement Placebo Injection
干预措施: Placebo Injection (Other)
Placebo
Placebo Supplement Placebo Injection
干预措施: Placebo supplement (Other)
Testosterone
Placebo Supplement Testosterone Injection
干预措施: Testosterone (Drug)
Testosterone
Placebo Supplement Testosterone Injection
干预措施: Placebo supplement (Other)
Protein Supplement
Protein Supplement Placebo Injection
干预措施: Protein Supplement (Dietary Supplement)
Protein Supplement
Protein Supplement Placebo Injection
干预措施: Placebo Injection (Other)
Protein Supplement + Testosterone
Protein Supplement Testosterone Injection
干预措施: Testosterone (Drug)
Protein Supplement + Testosterone
Protein Supplement Testosterone Injection
干预措施: Protein Supplement (Dietary Supplement)
结局指标
主要结局
Physical Performance
时间窗: Change from Baseline to 30-day Followup
Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance
次要结局
- Handgrip Strength(Change from Baseline to 30-day Followup)
- Physical Activity Level(Change from Baseline to 30-day Followup)
- 30 day re-admission(30 days post-discharge)