Enhancing Physical Activity in Patients After Lung Transplantation: Effectiveness and Feasibility of a Semi-automated Tele Coaching Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Daily number of steps at 12 weeks (short term effect)
研究概览
简要总结
Lung transplantation is an ultimate, effective treatment option for selected patients with end stage lung disease, improving quality of life and extending survival. Because of the improved survival during the last decades, enhancing the long term condition after lung transplantation has now become a focus for disease management.
The co-presence of non-communicable diseases is common and poses new challenges to disease management. These comorbidities have been related to physical activity in the healthy population. As in other chronic respiratory disease, physical inactivity is a common feature of patients after LTX. Despite near normal lung function, exercise intolerance and physical inactivity persist up to years after the transplantation. Literature on effective interventions to increase physical activity are scarce in this population.
Therefore, the present project aims to test the effectiveness of a tele coaching program to enhance physical activity and to analyze the association between physical activity and long-term health benefits in this population at risk. These research questions will be answered based on a randomized controlled trial. Patients that are active at baseline will be followed up in a cohort study.
详细描述
The aims of the present study are:
-
primary objective: To test the effectiveness of adding a semi-automated tele coaching intervention to enhance physical activity in patients after a first double lung transplantation, assessed at 12 weeks.
-
Secondary objectives:
- To test the long term effect of a semi-automated tele coaching intervention on physical activity, assessed at 52 weeks.
- To analyze the association between baseline physical activity, the change in physical activity and long term health benefits in this population at risk
- To relate the day-by-day pattern of physical activity to changes in the health status of patients.
- To investigate the patient's experience with the delivered intervention.
Therefore, the study will include stable patients at least 6 months and maximum 4 years after a first double lung transplantation. Based on a 1 week physical activity assessment, patients will be classified as active (mean steps >7500 steps) or inactive (mean steps < 7500). Inactive patients will be entered in a randomized controlled trial, using block randomization. Active patients will be followed for 1 year in a cohort study.
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 (Participant)
盲法说明
Patients in the control group will receive a sham version of the smartphone application
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable patients at least 6 months and maximum 4 years after the first double lung transplantation
- •Older than 30 years
- •Understand and able to work with the smartphone application, as judged by the investigator
排除标准
- •Having a diagnosis of Cystic Fibrosis
- •Musculoskeletal problems not allowing a normal gait pattern
- •Receiving a multi-organ transplantation or previously undergoing a solid-organ or bone marrow transplantation
- •Chronic rejection of the allograft before inclusion
- •Having a life expectancy <1year
结局指标
主要结局
Daily number of steps at 12 weeks (short term effect)
时间窗: 12 weeks
Change in daily mean step count 12 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in in chronic respiratory disease. Data obtained on days with more than 8 hours of wearing time will be used for further analysis.
次要结局
- Symptoms of fatigue(12 weeks and 52 weeks)
- ankle brachial index(52 weeks)
- Waist and hip circumference(52 weeks)
- HbA1c(52 weeks)
- Exercise capacity(12 weeks and 52 weeks)
- bone mineral density(52 weeks)
- Cardiopulmonary exercise test (only in patients 6-9 months post transplantation)(52 weeks)
- Metabolic syndrome(52 weeks)
- blood pressure(52 weeks)
- Body mass index(52 weeks)
- Body composition(52 weeks)
- Daily number of steps at 52 weeks (long term effect)(52 weeks)
- Systemic inflammation(52 weeks)
- vitamin D level(52 weeks)
- Proportion of responders(12 weeks and 52 weeks)
- Quadriceps force(12 weeks and 52 weeks)
- Health related quality of life(12 weeks and 52 weeks)
- Symptoms of anxiety and depression(12 weeks and 52 weeks)
- Time spent in at least moderate intense activity(12 weeks and 52 weeks)
- Mean walking time per day(12 weeks and 52 weeks)
- Lipid profile(52 weeks)
- HOMA IR(52 weeks)