The PSSMAR Study (Postacute Sarcopenia, Supplementation With β-hydroxyMethylbutyrate After Resistance Training)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from baseline physical performance-gait speed- at 12 weeks
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel study to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. Treatments compared will be β-hydroxymethylbutyrate (β-HMB) with a resistance training program or placebo with a resistance training program.
详细描述
Sarcopenia is a geriatric syndrome characterized by the loss of skeletal muscle mass and strength that occurs with advancing age; it is related to frailty, falls, worsening quality of life, and death in chronic and elderly patients. Diagnosis of sarcopenia is based on clinical criteria: presence of low muscle mass and the presence of low muscle function and/or low physical performance. The latest developments indicate that dietary supplementation combined with resistance exercise could be an option to improve muscle mass and function.
The objective of the study is to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance.
Design: A randomized, double-blind, placebo-controlled, parallel study with two intervention groups. The investigators shall compare placebo against an intervention with β-HMB in patients performing a resistance training program after an acute process (post-acute period) during 12 weeks. There will be 16 patients in each arm of the study. Additionally a one year follow up visit will be performed.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female ≥60 years old
- •sarcopenia diagnosis and case-finding criteria following European Working Group On Sarcopenia in Older People (EWGSOP)
- •being discharged from post-acute care geriatric unit for rehabilitation treatment
- •ambulatory prior to the recent acute process
- •cognitive situation that let them to understand and follow an active physical rehabilitation program (Mini-Mental Status Examination ≥21/30)
- •voluntary participation and being able and willing to provide an informed consent
排除标准
- •potential participants will be excluded if they have active malignancy (exception basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix)
- •major lower limb surgery over the past 6 months (knee or hip arthroplasty)
- •contraindication for resistance training
- •performed regular exercise in the last 6 months
- •use of any medications interfering with the nutritional intervention
- •serious clinical conditions that compromises and endanger the patient's life
- •contraindication, intolerance or allergy to β-hydroxymethylbutyrate
研究组 & 干预措施
β-hydroxymethylbutyrate
β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program
干预措施: β-hydroxymethylbutyrate (Dietary Supplement)
Placebo
Maltodextrin 3 grams once a day combined with a resistance training program
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from baseline physical performance-gait speed- at 12 weeks
时间窗: From baseline till 12 weeks
Physical performance will be assessed with gait speed in the 4-m walk test
Change from baseline handgrip strength at 12 weeks
时间窗: From baseline till 12 weeks
Handgrip strength will be measured by a hand-held dynamometer (JAMAR®, Nottinghamshire, UK) and expressed in Kg
Change from baseline physical performance-SPPB- at 12 weeks
时间窗: From baseline till 12 weeks
Physical performance will be assessed with gait speed in short physical performance battery
次要结局
- Change from baseline functional status at 12 weeks(From baseline till 12 weeks)
- Absolute functional gain in 12 weeks(From baseline till 12 weeks)
- Change from baseline rehabilitation impact indices at 12 weeks(From baseline till 12 weeks)
- Relative functional gain in 12 weeks(From baseline till 12 weeks)
- Number of hospital readmissions(From baseline till 12 weeks)
- Change from baseline lean and fat body mass (muscle mass) at 12 weeks(From baseline till 12 weeks)
- Number of adverse events(From baseline till 12 weeks)