Determination of the Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People With Functional Impairment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Maximum Inspiratory Pressure (MIP)
研究概览
简要总结
The global loss of muscle mass and strength associated with aging is a cause of functional impairment and disability, particularly in the older elderly (>80 years). Respiratory function can be severely compromised if there is a decrease of respiratory (RM) strength complicated by the presence of comorbidities and physical immobility. In this context, the need for supportive services involves the need for long-term care and consequently the institutionalization.
Previous studies have shown that the increase of RM strength has positive healthy effects, such as the increase in functional capacity, the decrease in RM fatigue, the decrease of dyspnoea and the improvement of quality of life, both in healthy people and patients. Therefore, specific RM training may be regarded as a beneficial alternative to improve RM function, and thus prevent physical and clinical deterioration in this frail population.
Study hypothesis: The inspiratory muscle training (IMT) would improve respiratory muscle strength and endurance, exercise capacity and quality of life in an elderly population, who are unable to engage in general exercise conditioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Barthel Index < 75 score
- •Mini-mental state examination ≥ 20 score
- •Inspiratory muscle weakness (MIP ≤ 30% predicted value)
排除标准
- •Ability to independently walk more than 14 m
- •Significant chronic cardiorespiratory diagnoses
- •Acute cardiorespiratory episode during the 2 previous months
- •Neurological, muscular, or neuromuscular problems interfering with the capacity to engage in the tests and training protocol
- •Active smokers or former smokers (< 5 years)
- •A terminal disease
研究组 & 干预措施
Control group
Usual care
Treatment 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.
干预措施: Threshold® Inspiratory Muscle Trainer (treatment). (Device)
结局指标
主要结局
Maximum Inspiratory Pressure (MIP)
时间窗: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
MIP is probably the most frequently reported noninvasive estimates of inspiratory 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 inspiration. The manoeuvre is generally performed at Residual Volume (RV). Reference: Am J Respir Crit Care Med. 2002;166:531-535.
Maximum Expiratory Pressure (MEP)
时间窗: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
MEP is probably the most frequently reported noninvasive estimates of expiratory 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 expiration. The manoeuvre is generally performed at Total Lung Capacity (TLC). Reference: Am J Respir Crit Care Med. 2002;166:531-535.
次要结局
- Maximal Voluntary Ventilation (MVV)(The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).)
- Time performed to walk 10 m distance (10mWT).(The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).)
- Maximal heart rate achieved at the end of the incremental arm ergometry test.(The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).)
研究者
Maria dels Angels Cebria i Iranzo, PT, PhD
Assistant Professor
University of Valencia