ACTRN12622000480785撤回2 期
A Single-Centre, Double-Blind, Randomized, Placebo-Controlled 2-Arm Study to Evaluate Safety and Efficacy of Intermittent Rapamycin On Muscle Strength and Endurance In Older Adults Following A 13-Week Exercise Program
Dr Brad Stanfield Ltd0 个研究点目标入组 40 人开始时间: 2022年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 65 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Male or female aged 65 years to 85 years at the time of signing informed consent
- •2. BMI between 18 and 40 and a maximum weight of 120kg at screening.
- •3. Currently sedentary lifestyle or performing moderate exercise for less than 15 mins, 3 times a week
- •4. Capable of providing written informed consent
- •5. Willing to swallow a #000 sized capsule
- •6. Willing and able to adhere to and comply with all study requirements, and attend all study visits
- •7. Able to complete the 30 second Chair Stand Test utilising correct technique
- •8. Is able to accommodate and use an exercycle at home for the duration of study participation
排除标准
- •1.Anaemia - Hg < 9.0 g/dl, Leukopenia - white blood cells (WBC) < 3,500/mm3, Neutropenia - absolute neutrophil count < 2,000/mm3 , or Platelet count - platelet count < 125,000/mm3
- •2.Planned surgery during the period of the study that is likely to impact on ability to perform required study exercises
- •3.Any medical or psychological condition which in the opinion of the investigator, may interfere with the participants ability to and comply with the study requirements and/or put the participant at significant risk.
- •4.Impaired wound healing or history of a chronic open wound.
- •5.Active infection at the time of signing consent.
- •6.Malignancy (except non-melanoma skin cancers, cervical carcinoma in-situ) within the last 5 years.
- •7.Known hypersensitivity, allergy, or any contraindication to Rapamycin or placebo (cellulose powder) or its excipients
- •8.Fibromyalgia or Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, Breast Implant Illness, or other conditions that impact the participants ability to perform the exercise program
- •9.Known congestive heart failure with New York Heart Association (NYHA) classification III or IV
- •10.COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification III or IV
- •11.Impaired renal function, as defined as glomerular filtration rate eGFR < 30
- •12.Type 1 diabetes or uncontrolled Type 2 Diabetes (defined as HbA1c at least 60 mmol/mol)
- •13.Metformin, Rapamycin, or rapalogs use within 6 months prior to baseline.
- •14.Impaired hepatic function, measured by alkaline Phosphatase (ALP), alanine aminotransferase (ALT), Albumin, or T. Bili, whereby the levels are 1.5x greater than the normal upper limit.
- •15.Any form of clinically relevant primary or secondary immune dysfunction or deficiency (e.g. X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID))
- •16.Chronic oral corticosteroid or immunosuppressive medication use (e.g. Enbrel, Humira, methotrexate).
- •17.Participation in any other study (for 30 days) prior to or during this study.
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