Effects of Respiratory Muscle Endurance Training on Blood Pressure, Exercise Performance and Sleep Quality in Healthy Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Prevalence of hypertension in the elderly is high. Given that hypertension is the leading cause of cardiovascular disease worldwide, safe and efficacious treatment options for this condition are highly desired. Apart from medication, changes in lifestyle are recommended to lower blood pressure, such as an increase in physical exercise. However, whole-body exercise is not feasible for all. Mobility disabilities, for example, increase sharply with age and are already common in middle age. For this population, it is necessary to have alternative, non-invasive interventions with similar effects on blood pressure. One such intervention might be respiratory muscle endurance training (RMET), but the effects on blood pressure are currently unknown.
The primary aim of this project is therefore to investigate the effects of RMET over the course of several weeks on resting blood pressure in healthy elderly. The secondary aim of the project is to evaluate the effects of RMET on uphill exercise performance in healthy active elderly given that elderly experience structural and functional changes of the lungs potentially affecting exercise performance. Finally, since prevalence of subjective sleep complaints is also high in the elderly, the present study will also investigate the effects of RMET on sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 55-80 years
- •Active (according to World Health Organisation Criteria)
- •Systolic blood pressure lower than 140 mmHg and diastolic blood pressure lower than 90 mmHg
- •Non-smoking
- •Body-Mass-Index (BMI): 18.5-29.9 kg·m-2
- •Normal lung function
排除标准
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Previous enrolment into the current study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Intake of blood pressure medication or history of hypertension
- •Intake of medications affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system
- •Acute illness or chronic conditions affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system
研究组 & 干预措施
Intervention
Respiratory muscle endurance training (30 minutes of volitional hyperpnoea at a target ventilation of 60-70% of the individual maximal voluntary ventilation for 5 days per week for 4 weeks).
干预措施: Respiratory muscle endurance training (Device)
Sham
Sham training will be performed 5 times a week for 4 weeks using a mock asthma inhaler filled with 5.5 mg lactose powder. Subjects will be instructed to inhale the powder according to inhaler instructions and to then perform one full inspiration to total lung capacity using custom-made, low resistance tubing, which elicits minimal resistance to breathing.
干预措施: Respiratory muscle endurance training (Device)
结局指标
主要结局
Blood pressure
时间窗: At baseline and after completion of the study (approximately one month)
Change in systolic and diastolic blood pressures (in mmHg) between baseline and after one month of training. Measurements will be done in triplicate after at least 10 minutes of quiet lying on a stretcher
次要结局
- Incremental test(At baseline and after completion of the study (approximately one month))
- Endurance capacity test(At baseline and after completion of the study (approximately one month))
- Sleep efficiency(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
- Heart rate during the night(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
- Sleep onset latency(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
- Fragmentation index(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
- Oxygen saturation during the night(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)
- Subjective sleep quality(At baseline between visits 1-2 and after completion of the study (approximately one month) at visits 4-5)