ACTRN12618001146280招募中未知
Osteogenic Exercise for Musculoskeletal and Metabolic Health during Weight Loss in Sarcopenic Obese Older Adults: A Pilot Study (OSMOSIS-P)
Dr. David Scott0 个研究点目标入组 60 人开始时间: 2018年7月12日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 89 Years（—）
- 性别
- All
入选标准
- •Prospective participants must be aged 60-89 years; have a body mass index (BMI) of 28 kg/m2; and a body fat percentage of greater than or equal to 30 (men) or of greater than or equal to 40 (women) determined by dual-energy X-ray absorptiometry (DXA); a Short Physical Performance Battery (SPPB) score of of less than or equal to 11 out of 12 indicating presence of a mobility limitation; willing, and has GP approval to complete a 12-week diet and exercise intervention; and also be willing to participate should they be randomised to either intervention arm.
排除标准
- •Participants are ineligible if they currently reside in a nursing home; are unable to walk 400m in 15 minutes without use of walking aids; are non-English speaking or have difficulty communicating with study personnel due to speech or hearing problems; have moderate or severe cognitive impairment defined as a Mini-Mental State Exam (MMSE) score of of less than or equal to 18 points out of 30; report 4 weeks or more of self-reported participation in a supervised exercise or dietary program targeted at weight loss or strength gains in the past six months; taking any medication or supplements that facilitate weight loss; are planning to be away from home for 4 weeks or more during the intervention; and self-reported diagnosis of: progressive neurological disorders including Parkinson’s Disease and multiple sclerosis; schizophrenia or bipolar disorder; severe knee or hip osteoarthritis (awaiting a joint replacement) that would interfere with ability to complete functional tests; cardiovascular disease (including NYHA Class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable cardiac defibrillator, or uncontrolled angina); lung disease requiring regular use of corticosteroids or supplemental oxygen; renal disease requiring dialysis; hyper- or hypothyroidism that would interfere with the weight loss program; and any other disorder of such severity that life expectancy is less than 12 months. Temporary exclusion criteria will include hip or knee replacement, spinal surgery, stroke, myocardial infarction, major heart surgery, deep vein thrombosis, or pulmonary embolus in the past 6 months.
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