A Protein-enriched, Milk-based Supplement to Counteract Sarcopenia in Acutely Ill Geriatric Patients Offered Resistance Exercise Training During and After Hospitalisation - a Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 6
- 主要终点
- Change in 30-s chair stand performance
研究概览
简要总结
The purpose of the study is to investigate if an increased protein intake, in the form of a protein-enriched, milk-based supplement, can enhance the beneficial effect of resistance training, offered during hospitalization and 12 weeks post discharge, in older patients. This will in part be evaluated from measures of muscle strength, muscle mass and physical functioning. Also, the study population's acceptance of the intervention product will be assessed along with measures related to 'cost-effectiveness'.
A sub-study will be performed in a sub-group (n=30) to investigate if bio-impedance analysis (BIA) correlates with Dual-Energy X-ray absorptiometry (DXA) at single time points, and to see if it is possible to track changes in lean body mass. In addition, the reliability of the bio-impedance analyzer will be evaluated.
Also, the prevalence and classification of sarcopenia will be assessed at baseline, and correlations to nutritional status will be investigated (n=120).
详细描述
Main study:
The study design is a block randomised, double-blind, placebo-controlled, multicentre intervention study. A total of 120 hospitalized older adults, above 70 years, will be recruited consecutively from the medical departments of three Hospitals in the Capital Region of Denmark (n=40 each place).
Participants will be randomized into two groups - one group receives protein-enriched, milk-based supplements and the other group receives iso-energetic placebo products. Both groups participate in the same standardized resistance training program, and will be blinded to the supplement content. One training session consists of three exercises of the lower extremities (3 sets of 10 repetitions, pursuing an intensity of 8-12 repetition maximum (RM)). While admitted, supervised resistance training is offered daily. After discharge, the participants are encouraged to perform the same program as self-training four times per week.To ensure progression (or regression if necessary) the participants receive follow-up home visits by a physiotherapist, and thus after discharge the participants are closely monitored. All participants, irrespective of allocation, will get a daily vitamin D supplement.
The study duration for each participant starts while admitted to hospital and lasts until 12 weeks after discharge. Endpoint assessments will be performed at baseline (> 72-h after admission to hospital), after discharge (> 72-h) and 12 weeks (± 2 days) after discharge. A few endpoints will be collected during follow-up (6 months post intervention). Data will be collected by study investigators blinded to the allocation of the participants.
Sub-study: 'Validation of a portable bio-impedance analyzer in a population of older adults ≥ 70 years for the assessment of muscle mass and changes in muscle mass over time' A sub-study will be performed to investigate if the portable InBody-230 BIA correlate with DXA at single time points in 30 hospitalized older people ≥ 70 years, and to see if it is possible to track changes in LBM during the 12-week intervention. Total LBM, total fat mass, and percent LBM will be measured and compared as well as appendicular and trunk LBM. In addition, the reliability of the portable bio-impedance analyzer will be evaluated by assessing the degree of agreement between two subsequent measurements. In continuation of recruitment to the primary study, a subset of participants (n=30) will be asked if they want to participate in this sub-study, irrespective of their allocation in the main study. The measurements are going to be performed twice, while hospitalized and 12 weeks after discharge (± 5 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged ≥ 70 years old
- •Able to speak and understand Danish
- •Expected length of stay > 3 days (evaluated by medical staff at department)
- •Ability to stand independently without walking aids
- •Admitted to the medical departments of Gentofte or Herlev Hospital or Rigshospitalet-Glostrup
排除标准
- •Active cancer
- •Renal insufficiency (eGFR < 30 mL/min/1.73m2)
- •Cognitive impairment (not able to comprehend the purpose of the study/give informed consent)
- •Terminal disease
- •Exclusively receiving enteral or parenteral nutrition
- •Milk/lactose allergy or intolerance
- •Planning to lose weight/go on a special diet
- •Planned transfer to other hospitals/departments
- •Pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis (BIA) measurements)
- •Not being able to lie still in seven minutes (only an exclusion criteria in the sub-study)
- •Withdrawal criteria: Death during admission (does not apply to subsequent admissions)
- •Withdrawal criteria: Discharge/transfer from the medical department before the intervention has started
研究组 & 干预措施
Resistance training and protein
Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x 125 ml protein-enriched, milk-based supplements (whey protein), in the same period (additional ~25 g protein and 1953 kJ per day). Daily vitamin D supplements.
干预措施: Protein (Dietary Supplement)
Resistance training and protein
Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x 125 ml protein-enriched, milk-based supplements (whey protein), in the same period (additional ~25 g protein and 1953 kJ per day). Daily vitamin D supplements.
干预措施: Resistance training (Other)
Resistance training and placebo
Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x125 ml iso-energetic placebo-supplements, in the same period. Daily vitamin D supplements.
干预措施: Placebo (Dietary Supplement)
Resistance training and placebo
Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x125 ml iso-energetic placebo-supplements, in the same period. Daily vitamin D supplements.
干预措施: Resistance training (Other)
Resistance training and placebo
Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x125 ml iso-energetic placebo-supplements, in the same period. Daily vitamin D supplements.
干预措施: Vitamin D (Dietary Supplement)
Resistance training and protein
Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x 125 ml protein-enriched, milk-based supplements (whey protein), in the same period (additional ~25 g protein and 1953 kJ per day). Daily vitamin D supplements.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Change in 30-s chair stand performance
时间窗: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Number of stand-ups from a chair in 30 seconds (modified version, help from armrests are allowed).
次要结局
- Change in hand grip strength(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Study population acceptance of product(12 weeks post discharge)
- Change in 4 m gait speed(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Appendicular lean body mass(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Change in Body weight(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Trunk lean body mass(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Readmission to hospital(From discharge until 12 weeks post discharge, and 6 months post discharge)
- Length of total hospital stay for readmissions(From discharge until 12 weeks post discharge, and 6 months post discharge)
- Mortality(From discharge until 12 weeks post discharge, and 6 months post discharge)
- Total lean body mass(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Change in Activities of daily living (ADL)(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Change in mobility(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Use of gait aid(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Length of hospital stay (LOS)(Day of discharge (from hospital))
- Change in cognitive functioning(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Use of home care(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Residence(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
- Change in health related Quality of life(Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
研究者
Forskningsenheden
Dietetics and Clinical Nutrition Research Unit
Copenhagen University Hospital at Herlev