The Impact of a Customized Respiratory Muscle Training and Maintenance Program on Cardiopulmonary Function in People With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- maximum inspiratory pressure
研究概览
简要总结
People with PD have lower cardiopulmonary function than their age matched peers. This decline can further impair a person's ability to participate in exercise and daily activities.
Furthermore, the limitations in cardiopulmonary function can have a severe impact on mortality. There is evidence indicating the positive changes IMT can have on cardiopulmonary function in people with PD. Through intensive daily exercise people with PD have shown improvements in maximum inspiratory pressure and maximum expiratory pressure though detraining does occur when the intervention is not continued. The purpose of the proposed study is to determine if improvements in expiratory muscle strength can be maintained with a maintenance inspiratory muscle training program. The hypothesis is that there will be a significant change from baseline at the three and six month follow ups.
详细描述
Testers will complete the following outcome measures at the pretest: height, weight, maximum inspiratory pressure, maximum expiratory pressure, heart rate, blood pressure, respiratory rate, six-minute walk test, and Fatigue Impact Scale in person.17,18 Participants, and caregivers if necessary, will be educated on how to complete the intensive IMT program. The dosage will be IMT 3 times/day for 20 repetitions each with resistance set at 30% of baseline maximum for 12 weeks. This training will occur at home.
Participants will record daily their completion of the intensive IMT. Investigators will contact participants weekly for follow-up of compliance and questions. Participants will be contacted either through email, text, or phone call, depending on their preference.
After 12 weeks of intensive IMT training, the investigators will complete the first posttest which will include the following assessments: maximum inspiratory pressure, maximum expiratory pressure, heart rate, blood pressure, respiratory rate, six-minute walk test, and fatiguability scale in person.
Participants, and caregivers if necessary, will be educated on the maintenance IMT program. The dosage for the maintenance program will be 33% of their intensive IMT program, which will result in IMT 1 time/day for 20 repetitions with resistance set at 30% of baseline maximum at the first posttest. The participants will continue the maintenance program for 12 more weeks.
Participants will record daily their completion of the maintenance IMT program. Investigators will contact participants weekly for follow-up of compliance and questions. Participants will be contacted either through email, text, or phone call, depending on their preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physician's diagnosis of Parkinson's disease
排除标准
- •people who are actively smoking, have a pacemaker, recent diagnosis of chronic obstructive pulmonary disease, bronchial asthma, active pulmonary disease within 1 month, or hospitalization within 2 months of time of study
结局指标
主要结局
maximum inspiratory pressure
时间窗: 5 minutes
measure of the maximum inspiratory cardiopulmonary pressure
Fatigue Impact Scale
时间窗: 10 minutes
measure of a person's self report fatigue, ranges from 0-36 and higher score indicates greater impact of fatigue
6 minute walk test
时间窗: 8 minutes
distance walked in 6 minutes
respiratory rate
时间窗: 1 minute
breaths per minute
maximum expiratory pressure
时间窗: 5 minutes
measure of the maximum expiratory cardiopulmonary pressure
blood pressure
时间窗: 1 minute
measure of rest blood pressure
heart rate
时间窗: 1 minute
heart beats per minutes
次要结局
未报告次要终点
研究者
Kristen Barta
Associate Professor
University of St. Augustine for Health Sciences