Effects and Costs of Preventive Physiotherapy Intervention in Institutionalized Elderly People With Sarcopenia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in Muscle mass
研究概览
简要总结
This study evaluates two strength training protocols (one in peripheral muscles and one in inspiratory muscles) in the improvement of skeletal muscle mass and function in institutionalized elderly with sarcopenia. Participants will be assigned randomly in a control or one of both experimental groups.
详细描述
Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death (Goodpaster et al, 2006; Delmonico et al, 2007). The contributing factors are those related to aging process, non-optimal diet, bed rest or sedentary lifestyle, chronic diseases and certain drug treatments. Most of these factors are present in the older population with comorbidity, frequently institutionalized to receive a professional long-term care.
Since the European Working Group on Sarcopenia in Older People (Cruz-Jentoft et al, 2010) recommends using the presence of both low muscle mass and low muscle function (strength and/or physical performance) for the diagnosis of sarcopenia, interventions should be focused in both criteria. The aim of this study is to prevent loss of skeletal muscle mass and strength in institutionalized elderly with sarcopenia.
To this purpose, the investigators study undertakes two physiotherapy interventions to preventing/treating Sarcopenia, namely, maintenance of muscle mass and improvement of strength in peripheral and respiratory muscles. Both interventions are common in the following features: supervision, duration, frequency and intensity of the training program.
The primary outcomes are those related to muscle mass and strength. Secondary outcomes will be related to muscle function (muscle endurance and/or physical performance), costs and health status (number of falls and fractures, exacerbations of chronic diseases, hospitalizations and deaths during the year after concluding the physiotherapy interventions).
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
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People aged > 65 years
- •Sarcopenia diagnosis (Tyrovolas et al., 2015)
- •Medically stable at least 2 months before the study
排除标准
- •Cardiorespiratory, muscular, neurological, or neuromuscular disease that could interfere in the proper performance of assessment and/or training protocols.
- •Endocrine and metabolic disorders that might have had an effect on muscle mass.
- •Severe disorder of hydration status that could interfere in Bioelectrical Impedance Analysis (Rubbieri et al., 2014).
- •A terminal disease diagnosis.
- •Mini-Mental State Examination Index ≤ 20 score.
研究组 & 干预措施
Control group
Usual care
Respiratory training group
Participants will breathe against a load ≥ 50% of their baseline MIP, after which loads will increase according to the participant's tolerance across the remaining training period, using a Borg scale rating of 4 to 6 on perceived exertion as an indicator of adequate training intensity.
Intervention: Inspiratory Muscle training (12-weeks)
干预措施: Inspiratory Muscle Training (IMT). (Other)
Peripheral training group
Participants will load ≥ 50% of their maximum muscle force (Kg), after which load will increase according to the participant's tolerance across the remaining training period, using a Borg scale rating of 4 to 6 on perceived exertion as an indicator of adequate training intensity.
Intervention: Peripheral muscle training (12-weeks)
干预措施: Peripheral muscle training (Other)
结局指标
主要结局
Change in Muscle mass
时间窗: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Bioimpedance analysis (BIA) estimates the volume of fat and lean body mass. The test itself is inexpensive, easy to use, readily reproducible and appropriate for both ambulatory and bedridden patients. Reference: J Aging Phys Act 2015;23(4):597-606. Korean J Intern Med 2016;31:643-650.
Change in Maximum Respiratory Pressures (MIP and MEP)
时间窗: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
MIP and MEP are probably the most frequently reported non-invasive estimates of respiratory muscle strength. Ever since Black and Hyatt (1969) reported this technique it has been widely used in patients, healthy control subjects across all ages, and athletes. Pressure is recorded at the mouth during a quasi-static short (few seconds) maximal breathing. Reference: Am J Respir Crit Care Med. 2002;166:531-535.
Change in peripheral muscle strength
时间窗: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Maximal isometric muscle strength (Kg) was assessed for knee extension (Quadriceps femoris) and elbow flexion (Biceps brachii). Reference: J Am Geriatr Soc 2002; 50: 461-7.
Change in Handgrip strength
时间窗: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Isometric hand grip strength is strongly related with lower extremity muscle power, knee extension torque and calf cross-sectional muscle area. In practice, there is also a linear relationship between baseline handgrip strength and incident disability for activities of daily living. Reference: Age and Aging. 2010;39:412-423.
次要结局
- Change in Time performed to walk 10 m distance (10mWT).(The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).)
- Change in Maximal Voluntary Ventilation (MVV)(The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).)
研究者
Maria dels Angels Cebria i Iranzo, PT, PhD
Assistant Professor
University of Valencia