Feasibility and Effectiveness of a Home Monitored Rehabilitation Intervention Using an Exergaming Approach in COPD Patients - a Randomized, Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
Study title Feasibility and effectiveness of a home monitored rehabilitation intervention using an exergaming approach in COPD patients - a randomized, controlled study.
Background and rationale Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease characterized by persistent airflow limitation caused by significant exposure to noxious particles or gases, particularly cigarette smoking. In Sweden the prevalence of COPD is approximately 8% and the annual estimated cost for society of 9.1 billion SEK. Improving exercise capacity and physical activity levels are important goals in management of patients with COPD and are strong determinants of positive outcomes, including increased quality of life. Major barrier for rehabilitation recommendations is the limited access and adherence to organized center-based exercise programs. Major barriers related to the side of health care organization are budgets and infrastructure and the limitation in time of the programs. From patient's perspective major barriers exist, like distance, and lack of transport to the unit, also in relation to the frequency of the program, which is commonly two times a week.
Research question and objectives The primary objective of this study is to investigate whether home-based telemonitored supervised exercise programs using an exergaming approach will be associated to improved physical fitness, measured with the (1-minute sit-to-stand test, 1-MSTST) compared to the ordinary care.
The secondary objectives of this study are:
- To investigate whether a home-based exergaming program is associated with improved health-related quality of life, exercise capacity, physical activity levels and body composition.
- To investigate if the home-based exergaming program is associated with less exacerbations.
- To investigate if the home-based exergaming program is associated with improved health care utilization and/or less hospitalization from all causes?
Study design This is an open label , randomized controlled clinical study. The study takes place at the COPD-center at Sahlgrenska University hospital. Subjects will be randomized to either the use of the ALKIT exergaming tool in combination with telemonitored supervision by a physiotherapist or ordinary care without this system at their first visit. A total of 92 subjects will be included in the study, 46 in every arm. The intervention will include exergames performed 3 times a week for 12 weeks, consistent with the current recommendations. Pre-and post-intervention tests will be performed and subjects in both groups will be assessed. The tests include: 1-minute sit-to-stand test, 6-minute walk test, and timed-up and go. Two self- assessed questionnaires will be filled in: COPD Assessment Test and EQ5D-5L. Subjects will be also measured for quadriceps muscle strength, shoulder flexion and body composition. Additionally, physical activity level will be assessed by outcomes of pedometer worn over a week. Moreover, exacerbations and health care utilization will be measured. Users' perception of the exergaming program will be also investigated.
Population and study size The study will include a total of 92 subjects, 46 in the intervention- and 46 in the control arm. For each participant, the total study participation time will be 12 weeks. A randomization list will be produced with random assignment of treatment groups in a ratio of 1:1
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate and signed informed consent form
- •Diagnosis of COPD
- •FEV1/FVC (post bronchodilator) <0.7
- •GOLD severity grade B/D
- •FEV, < 80% predicted
- •Cognitive ability relevant for the studies as judged by the investigator
- •Living in their own home and able to manage their activities of daily living
排除标准
- •Rapidly progressing severe disease other than COPD and COPD-related diseases.
- •Influencing the HRQOL during the study time as judged by the investigator, e.g. long-term stay (>2 weeks) away from home during the study period.
- •Inability to communicate in Swedish.
- •Any condition that may interfere with the possibility for the subject to comply with the study protocol.
- •Already participating in the pulmonary rehabilitation training group 2 times a week.
研究组 & 干预措施
Exergaming
The combination of 1) game-console based exercise programs, 2) specifically designed by professional physiotherapists with focus on subjects with a chronic lung disease and 3) weekly distant monitoring with close supervision by a physiotherapist. Individually prescribed exercise program based on tests of patient's physical fitness.
干预措施: Alkit eSence (Device)
Standard rehabilitation
Standard rehabilitation at the COPD-Center. This includes recommendations about physical activity according to the general guidelines, however, individualized after each subject's physical fitness level.
干预措施: Standard rehabilitation (Other)
结局指标
主要结局
Physical activity
时间窗: Baseline and 12 weeks after baseline
Change in level of physical activity will be objectively measured with 1-minute sit to stand test
次要结局
- Exercise capacity(Baseline and 12 weeks after baseline)
- Number of exacerbations(Baseline and 12 weeks after baseline)
- Body composition(Baseline and 12 weeks after baseline)
- Body strength(Baseline and 12 weeks after baseline)
- Health-related quality of life(Baseline and 12 weeks after baseline)
- Healthcare utilization(Baseline and 12 weeks after baseline)