Balance Training: Its Effect on Pulmonary Rehabilitation of Elderly Subjects With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Balance
研究概览
简要总结
The aim of the study will be to verify whether the addition of an exercise program aimed to improve balance can reduce the risk of falling in subjects with COPD over 80 years of age compared to the standard rehabilitation program. Patients will be randomly assigned in two groups (intervention and control). The pulmonary rehabilitation (PR) program is organized in accordance with current guidelines.
详细描述
Chronic Obstructive Pulmonary Disease-COPD is the most prevalent pathology among chronic airway diseases. The average age of life has increased. Subjects over 80 years old have peculiar characteristics. Individuals with COPD have an increased risk of falling compared with healthy peers. A pulmonary rehabilitation program reduces the risk of falling as measured by gait speed. Balance training on the elderly has been shown to be effective in improving muscle strength, coordination, balance and in reducing the risk and number of falls and the fear of falling.
The enrolled subjects will complete an in-patient PR program according to enrollment.
Control: education, aerobic and strength training and callisthenic exercises. Intervention: education, aerobic and strength training as group Control and balance training. At baseline will be recorded: demographics and anthropometrics, comorbidities, drug therapy, flow/volume curve, arterial blood gases, serum hemoglobin, history of fall, exacerbations and risk of sarcopenia. Before and after the PR the following outcome measures will be assessed: balance performance, peripheral muscle strength, gait speed, health status, dyspnea, quality of life, exercise capacity, confidence with balance and perceived change. Sample size calculation was performed based on the primary endpoint of the study. We estimate a number of 50 subjects.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 80 years old,
- •Diagnosis of COPD according to GOLD Guidelines (Tiffenau Index <70%) under optimized medical treatment,
- •Able to perform and complete study procedures.
排除标准
- •Anticholinergic Cognitive Burden score ≥3,
- •Mini-Mental State Examination <22,
- •Acute or chronic impairment and/or medical diseases that are likely to preclude exercise testing and PR.
- •Brain lesions,
- •Inner ear disease
- •Visual deficit,
- •Lower limb surgery in the previous 6 months.
研究组 & 干预措施
Control
Educational interventions, aerobic and strenght training, flexibility exercises.
干预措施: Standard pulmonary rehabilitation program (Other)
Intervention
Educational interventions, aerobic and strenght training, balance training.
干预措施: Balance training added on standard pulmonary rehabilitation (Other)
结局指标
主要结局
Balance
时间窗: 3 weeks
Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).
次要结局
- Gait speed(3 weeks)
- Dyspnea(3 weeks)
- Peripheral muscle strenght(3 weeks)
- Dyspnea on daily life activities(3 weeks)
- Confidence with balance(3 weeks)
- Health status(3 weeks)
- COPD Quality of life(3 weeks)
- Exercise capacity(3 weeks)
- Perceived change(3 weeks)
研究者
Elisabetta Zampogna
Dr
Istituti Clinici Scientifici Maugeri SpA