Effects of a Long-term Home-based Exercise Training Program Using Minimal Equipment vs Usual Care in COPD Patients: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
研究概览
简要总结
The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.
详细描述
Exercise training is an important component of pulmonary rehabilitation (PR) the management of chronic obstructive pulmonary disease (COPD) and numerous trials have shown large improvements in health-related quality of life (HRQoL) and exercise capacity in persons with COPD. However, the great majority of patients who would benefit from PR never follow such a program. Moreover, many COPD patients are either not instructed to exercise at all or fail to adhere to exercise training at home after completing PR.
This study evaluates a newly developed exercise training program that requires minimal equipment (i.e., only a chair and elastic bands) and can be easily implemented long-term in the patient's home-setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Signed informed consent after being informed
- •Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)<70% predicted, FEV1<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a GOLD stage II-IV
- •No participation in an inpatient or outpatient pulmonary rehabilitation within the last 12 months
- •Male and female patients ≥40 years of age
- •Knowledge of German language to understand study material and assessments
排除标准
- •Patients not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations.
- •Planned participation in a pulmonary rehabilitation program
研究组 & 干预措施
Exercise intervention
Home-based, minimal equipment exercise training program.
干预措施: Exercise (Behavioral)
Control
Usual care (study participation does not have any impact on regular treatment decisions, including participation in other exercise training programs).
结局指标
主要结局
Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
时间窗: Change from baseline to 12 months
Dyspnea domain of the CRQ; 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
次要结局
- Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)(Change from baseline to 12 months)
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline to 12 months)
- Symptoms (COPD Assessment Test; CAT)(Change from baseline to 12 months)
- Health status (Feeling Thermometer; FT)(Change from baseline to 12 months)
- Health-related quality of life (EuroQOL; EQ-5D-5L)(Change from baseline to 12 months)
- Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)(Change from baseline to 3, 6 and 12 months)
- Functional exercise capacity (Six-Minute Walk Test; 6MWT)(Change from baseline to 12 months)
- Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)(Change from baseline to 12 months)
- Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty)(Change from baseline to 12 months, measured during 1 week prior to the visits)
- Exacerbations of COPD (event based, patient reported)(During the entire study, assessed at 3, 6 and 12 months)