Effect of the SpiroGym App on Voluntary Cough Strength in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Voluntary peak cough flow
研究概览
简要总结
The pilot study by Srp et al. (2021) proved that the SpiroGym app was feasible for supporting expiratory muscle strength training (EMST) in Parkinson's disease (PD) patients. Two weeks of intensive EMST coupled with SpiroGym were sufficient to significantly improve the participants' voluntary peak cough flow (PCF). The improvement was quantitatively comparable to the results of other intensive EMST studies with longer durations. When interpreting such rapid improvement, the impact of SpiroGym's visual feedback was considered. It was assumed that visual feedback increased training effort compared to regular training without immediate control. However, comparative studies were required to verify the possible additional effects of visual feedback on voluntary PCF compared to EMST without feedback.
详细描述
Goal: To explore the visual feedback effect of the SpiroGym app in EMST on voluntary peak cough
Hypothesis 1: Change in voluntary peak cough flow will be higher in the experimental group than in the active control group after 8weeks and 24 weeks of EMST.
Study Design: A double-blind, randomized controlled trial
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
- Double (Participant, Outcomes Assessor)
盲法说明
During the whole study protocol, patients did not receive information about testing the SpiroGym app. They will receive information that we are testing two types of expiratory muscle strength training programs.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinsons disease
- •Stable dopaminergic medication (stable dose for at least 1 month)
排除标准
- •Other neurological disorders
- •Difficulty complying due to neuropsychological dysfunction (dementia with a score of less - - than 19 on the Montreal Cognitive Assessment)
- •Breathing disorders or diseases
- •Smoking in the past 5 years
- •Uncontrolled hypertension
研究组 & 干预措施
Expiratory muscle strength training + SpiroGym application
The experimental arm will undergo 8 weeks of expiratory muscle strength training coupled with SpiroGym app.
干预措施: Expiratory muscle strength training + SpiroGym application (Device)
Expiratory muscle strength training
The experimental arm will undergo 8 weeks of expiratory muscle strength training.
干预措施: Expiratory muscle strength training (Device)
结局指标
主要结局
Voluntary peak cough flow
时间窗: 1 week before baseline, baseline, 8 weeks, 24 weeks
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
次要结局
未报告次要终点
研究者
Martin Srp, Ph.D.
Ph.D.
General University Hospital, Prague