The Effects of Inspiratory Muscle Training on Physical Activity and Quality of Life in Lung Transplantation Candidates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 主要终点
- Change from baseline International physical activity questionary short form (IPAQ-SF) score at 3-months
研究概览
简要总结
Inspiratory Muscle Training (IMT), which is used to strengthen the respiratory muscles, is one of the techniques used in PR. It is mostly used in patients with chronic obstructive pulmonary disease, and has been shown to be beneficial for functionality and also for relieving dyspnea perception. It is reported in the guidelines that IMT has additional benefit for endurance in COPD patients. However, there are no studies related to its use and effectiveness in lung transplantation. In this study, investigators hoped to increase these known benefits by adding IMT to the standard Pulmonary Rehabilitation.
There are two main objectives of this study:
- to examine the effect of inspiratory muscle training on physical activity status and quality of life in lung transplantation candidates,
- to compare physical activity and quality of life changes between the IMT+PR group and the PR group
详细描述
The patients in the lung transplantation waiting list were included the study. These patients were with severe lung disease requiring transplantation, and that the intervention was undertaken before any lung transplantation. The patients were eligible for inclusion if participitants have: a diagnosis of terminally severe lung disease, being listed for lung transplantation, medically stable, had no orthopedic or cardiac problems that would prevent them from exercising and had no transfer problem to the PR centre.
Participants who meet the study inclusion criteria and complete the baseline assessments were randomly allocated into one of the two groups: namely Pulmonary Rehabilitation plus Inspiratory Muscle Training Group (IMT+PR) or Pulmonary Rehabilitation Group (PR) using a numbered series of 34 prefilled envelops specifying group assignment generated by a computer-based program.
All patients underwent supervised PR program on 2 days per week for 3 months. Apart from that, participitant were asked to perform the home exercise program which was scheduled as 3 days per week and fill out the exercise follow-up form. The study group was provided with IMT in addition to the standard program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of terminally severe lung disease,
- •being listed for lung transplantation,
- •medically stable,
- •had no orthopedic or cardiac problems that would prevent them from exercising
- •had no transfer problem to the PR centre.
排除标准
- •Malignancy in the last 2 years,
- •Other advanced major organ / system dysfunction that can not be treated outside the lung,
- •Untreated non-pulmonary infection,
- •Disputed medical treatment discontinuity,
- •Untreatable psychiatric illness or psychosocial condition that interferes with treatment compliance,
- •No appropriate, reliable social support,
研究组 & 干预措施
IMT+PR Group
Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. In addition standard pulmonary rehabilitation, patients received inspiratory muscle training.
干预措施: Inspiratory muscle training (Other)
IMT+PR Group
Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. In addition standard pulmonary rehabilitation, patients received inspiratory muscle training.
干预措施: Pulmonary rehabilitation (Other)
PR group
Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training.
干预措施: Pulmonary rehabilitation (Other)
结局指标
主要结局
Change from baseline International physical activity questionary short form (IPAQ-SF) score at 3-months
时间窗: Three months
including seven questions on the frequency and duration of time spent in physical activity in the past 7 days to calculate a score for each domain (walking, moderate-intensity activities and vigorous-intensity activities) and an overall grand total expressed in MET-minutes/week.
Change from baseline Saint George Respiratory Questionaire score at 3-months
时间窗: Three months
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
次要结局
- Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months(Three months)
- Change from baseline distance covered in six minute walking test at 3-months(Three months)
研究者
esra pehlivan
Principal investigator
Istanbul Medipol University Hospital