The Long-term Effects of a Tele Coaching Intervention in Patients With COPD: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Daily number of steps at 12 months
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of mortality and morbidity around the world. Studies revealed that patients with COPD are less active than age-matched healthy controls and activity level decreases with disease severity. Higher levels of physical activity is related to important health-related outcomes, such as lower mortality rate and hospital admissions. Additionally, increasing physical activity is related with substantial health benefits. Patients with COPD have a higher risk of developing insulin resistance, hypertension, dyslipidemia, osteopenia, leading to chronic diseases such as coronary heart disease, type 2 diabetes and osteoporosis, which have been related to physical inactivity in the healthy population. Moreover, physical inactivity has been related to the occurrence of comorbidities in patients with COPD. Therefore, improving physical activity levels is a recommended treatment in the disease management in all patients with COPD and is implemented in the recent GOLD guidelines for all patients with COPD, regardless of the disease severity.
The research group investigated the effect of a 3-month semi-automatic tele-coaching intervention on physical activity levels in patients with COPD. The tele coaching intervention led to a significant improvement on physical activity in the intervention group. Although this trial showed positive results on physical activity, further research is needed, mainly to investigate the long-term (12 months) effectiveness of such interventions and the added value of a smartphone application on top of a simple step counter providing feedback. Additionally, since physical activity is related to the development of comorbidities, the investigators aim to explore the influence of improving physical activity levels on the occurrence of cardiovascular, metabolic and musculoskeletal comorbidities. Finally, this study will explore baseline characteristics (such as social support, self-efficacy, dynamic hyperinflation, etc.) that can predict success in this intervention.
详细描述
The aims of the present study are:
- primary objective: To investigate the changes in physical activity after a 12-month tele coaching intervention (including individualized goal setting, feedback, motivational contacts with coach and a step counter providing direct feedback), compared to a sham group receiving a light coaching intervention (feedback from step counter and static goal setting, without additional motivation or contact with the coach).
- secondary objectives:
A. Investigate the effect of a 12-month tele coaching intervention on exercise capacity, muscle force, quality of life, physical activity from a patient's perspective, dyspnea-related fear and comorbidities.
B. Confirming previous findings on short-term effects (or lack of effect) of the tele coaching intervention on physical activity, exercise capacity and quality of life, assessed at 6 months.
C. Identifying possible baseline characteristics that are determinants of the change in physical activity after the 12-month tele coaching intervention.
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. Patients are unaware of the difference between the coaching programs.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with COPD (GOLD criteria post bronchodilator FEV1/FVC < 0.70)
- •Patients under medical follow-up of a respiratory physician or general practitioner with no moderate (ambulatory treated) and/or severe (requiring a hospital admission) exacerbation in the past month
- •Older than 40 years old
- •Smoking history with more than 10 pack years
排除标准
- •The presence of orthopedic or other problems not allowing an increase in physical activity levels
- •Unable to learn to work with a new electronic device (e.g. smartphone), as judged by the investigator
- •Underwent lung transplantation or active on the lung transplantation list
- •Involved in or planned to start with a structured multidisciplinary rehabilitation program
结局指标
主要结局
Daily number of steps at 12 months
时间窗: 12 months
Change in daily mean step count 12 months 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 patients with COPD. At least 4 valid weekdays (\> 8 hours of wearing time during waking hours) is necessary to label the physical activity measurement as valid.
次要结局
- Mean sedentary time per day(6 months and 12 months)
- Quadriceps force(6 months and 12 months)
- Health status(6 and 12 months)
- Physical activity from a patients' perspective(6 months and 12 months)
- Health related quality of life: CRDQ-SAS(6 months and 12 months)
- Daily number of steps at 6 months(6 months)
- Minutes per day spent in at least moderate intense activities(6 months and 12 months)
- Mean walking time per day(6 months and 12 months)
- Exercise capacity(6 months and 12 months)
- Functional performance(Only in Ghent - as soon as possible and max 14 days after the occurrence of an COPD exacerbation)
- Dyspnea-related fear(6 months and 12 months)
- Symptoms of anxiety and depression(12 months)
- Autonomic function(Only in Ghent - 6 months and 12 months; additionally at 18 months and 24 months in case of extended design)
- Autonomic symptoms(Only in Ghent - 6 months and 12 months; additionally at 18 months and 24 months in case of extended design)