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一项关于监督下的渐进性跨连续体力量训练和蛋白质补充对老年内科患者影响的随机对照试验:STAND-Cph试验。

A randomized controlled trial of the effect of supervised progressive cross-continuum strength training and protein supplementation in older medical patients: the STAND-Cph trial.

作者信息

Pedersen Mette Merete, Petersen Janne, Beyer Nina, Larsen Helle Gybel-Juul, Jensen Pia Søe, Andersen Ove, Bandholm Thomas

机构信息

Clinical Research Centre, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.

Section of Biostatistics, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5 Entrance B, 2nd floor, 1014, Copenhagen K, Denmark.

出版信息

Trials. 2019 Nov 28;20(1):655. doi: 10.1186/s13063-019-3720-x.

Abstract

BACKGROUND

During hospitalization, older adults (+ 65 years) are inactive, which puts them at risk of functional decline and loss of independence. Systematic strength training can prevent loss of functional performance and combining strength training with protein supplementation may enhance the response in muscle mass and strength. However, we lack knowledge about the effect of strength training commenced during hospitalization and continued after discharge in older medical patients. This assessor-blinded, randomized study investigated the effect of a simple, supervised strength training program for the lower extremities, combined with post-training protein supplementation during hospitalization and in the home setting for 4 weeks after discharge, on the effect on change in mobility in older medical patients.

METHODS

Older medical patients (≥ 65 years) admitted acutely from their home to the Emergency Department were randomized to either standard care or supervised progressive strength training and an oral protein supplement during hospitalization and at home 3 days/week for 4 weeks after discharge. The primary outcome was between-group difference in change in mobility from baseline to 4 weeks after discharge assessed by the De Morton Mobility Index, which assesses bed mobility, chair mobility, static and dynamic balance, and walking. Secondary outcomes were 24-h mobility, lower extremity strength, gait speed, grip strength and activities of daily living.

RESULTS

Eighty-five patients were randomized to an intervention group (N = 43) or a control group (N = 42). In the intervention group, 43% were highly compliant with the intervention. Our intention-to-treat analysis revealed no between-group difference in mobility (mean difference in change from baseline to 4 weeks, - 4.17 (95% CI - 11.09; 2.74; p = 0.24) nor in any of the secondary outcomes. The per-protocol analysis showed that the daily number of steps taken increased significantly more in the intervention group compared to the control group (mean difference in change from baseline to 4 weeks, 1033.4 steps (95% CI 4.1; 2062.7), p = 0.049, adjusted for mobility at baseline and length of stay; 1032.8 steps (95% CI 3.6; 2061.9), p = 0.049, adjusted for mobility at baseline, length of stay, and steps at baseline).

CONCLUSIONS

Simple supervised strength training for the lower extremities, combined with protein supplementation initiated during hospitalization and continued at home for 4 weeks after discharge was not superior to usual care in the effect on change in mobility at 4 weeks in older medical patients. For the secondary outcome, daily number of steps, high compliance with the intervention resulted in a greater daily number of steps. Less than half of the patients were compliant with the intervention indicating that a simpler intervention might be needed.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT01964482. Registered on 14 October 2013. Trial protocol PubMed ID (PMID), 27039381.

摘要

背景

在住院期间,老年人(65岁及以上)活动不足,这使他们面临功能衰退和失去独立生活能力的风险。系统的力量训练可以防止功能表现的丧失,将力量训练与蛋白质补充相结合可能会增强肌肉质量和力量的反应。然而,我们缺乏关于住院期间开始并在出院后继续进行力量训练对老年内科患者影响的知识。这项评估者盲法随机研究调查了一项简单的、有监督的下肢力量训练计划,在住院期间以及出院后在家中持续4周进行训练后补充蛋白质,对老年内科患者活动能力变化的影响。

方法

从家中急性入院至急诊科的老年内科患者(≥65岁)被随机分为标准护理组或接受有监督的渐进性力量训练组,并在住院期间和出院后在家中每周3天、持续4周接受口服蛋白质补充剂。主要结局是通过德莫顿活动指数评估的出院后4周时活动能力相对于基线的组间差异,该指数评估床上活动、椅子移动、静态和动态平衡以及行走能力。次要结局包括24小时活动能力、下肢力量、步态速度、握力和日常生活活动能力。

结果

85名患者被随机分为干预组(N = 43)或对照组(N = 42)。在干预组中,43%的患者对干预高度依从。我们的意向性分析显示,在活动能力方面两组间无差异(从基线到4周变化的平均差异为-4.17(95%CI -11.09;2.74;p = 0.24)),在任何次要结局方面也无差异。符合方案分析显示,与对照组相比,干预组每天的步数增加显著更多(从基线到4周变化的平均差异为1033.4步(95%CI 4.1;2062.7),p =

0.049,对基线活动能力和住院时间进行调整;1032.8步(95%CI 3.6;2061.9),p = 0.049,对基线活动能力、住院时间和基线步数进行调整)。

结论

对于老年内科患者,简单的有监督的下肢力量训练,结合住院期间开始并在出院后在家中持续4周的蛋白质补充,在出院后4周时对活动能力变化的影响并不优于常规护理。对于次要结局,即每日步数,对干预的高依从性导致每日步数增加更多。不到一半的患者对干预依从,这表明可能需要更简单的干预措施。

试验注册

ClinicalTrials.gov,NCT01964482。于2013年10月14日注册。试验方案PubMed ID(PMID),27039381。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59d1/6883554/ca191798e1a9/13063_2019_3720_Fig1_HTML.jpg

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