NL-OMON26761招募中不适用
Feasibility of a 13-week resistance exercise and protein supplementation intervention in sarcopenic geriatric rehabilitation inpatients admitted after a hip fracture: EMPOWER-GR
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Admitted to a geriatric rehabilitation centre for a hip fracture
- •2) Aged 65 years or older
- •3) Diagnosed with stage 1 or 2 sarcopenia (sarcopenia probable or confirmed) according to the revised European Working Group on Sarcopenia in Older People (EWGSOP2) definition
- •4) Written informed consent
排除标准
- •1) Palliative care or other adverse prognosis precluding post-intervention follow-up
- •2) Specific medical history such as:
- •Patients with ongoing cancer treatment or radiotherapy/ chemotherapy in the last 6 months.
- •Any gastrointestinal disease that interferes with bowel function and nutritional intake (e.g. constipation or diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding)
- •Other relevant medical history or medication that could prevent participation in the intervention or affect the study outcome as judged by the investigator (e.g. severe dementia, hypercalcaemia)
- •3) Patients in isolation/quarantaine
- •4) BMI >40 kg/m2 (morbid obesity)
- •5) Renal impairment (estimated Glomerular Filtration Rate <30 mL/min/1.73m2)
- •6) Dietary characteristics: known allergy to cow’s milk and milk products or the ingredients of the study products, known allergy to soy, known galactosaemia, known severe lactose intolerance, patients requiring a fibre-free diet
- •7) Current alcohol or drug abuse in opinion of the investigator
- •8) Unable to provide informed consent (e.g. severe dementia or deliriumpatient and legal representative)
- •9) Not understanding Dutch
- •10) Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •11) Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to baseline
研究者
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