A feasibility trial evaluating mobility and strength training with and without protein supplements in pre-frail/frail older adults with low protein intake

niversity of Oxford0 个研究点目标入组 50 人开始时间: 2022年10月18日最近更新: 2024年8月26日

适应症

试验速览

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39139274/ (added 14/08/2024)

•1. Aged 65 years and older
•2. Frail (at least three criteria) or pre-frail (one or two criteria) as defined by the Fried Frailty criteria and must include slow walking speed (or difficulty walking).
•3. Low protein intake (<1 g protein/kg body weight/day) measured by the average of two 24-hour dietary recall assessments.
•4. Willing and able to provide informed consent to participate

•1. Dementia or cognitive impairment (defined as an Abbreviated Mental Test score of 6 or less)
•2. Inability to walk 3 m without assistance (walking aid permitted)
•3. Unable to follow verbal instructions which would make participation in the exercise group impractical including severe hearing impairment not corrected by a hearing aid or inability to follow simple safety instructions (e.g. English comprehension)
•4. Living in a residential care or nursing home
•5. Pre-existing diagnosis of:
•5.1. Stroke in the last 6 months
•5.2. Parkinson’s Disease
•5.3. Acute, unstable physical illness that would make participation in the exercise programme unsafe
•5.4. Dysphagia or swallowing problems that requires a modified diet
•5.5. Type 1 diabetes or Type 2 diabetes on insulin
•5.6. Severe kidney disease (stage 4 or 5)
•6. Already taking protein supplements
•7. Known allergies to ingredients of protein supplement (milk, soya) or lactose intolerant
•8. Poor kidney function defined by an Estimated Glomerular Filtration Rate (eGFR) of <30 (blood test)
•9. High risk of developing refeeding problems based on NICE guidance

发起方