Effects of Face-to-face Versus Telematic Supervision During a Community-based Exercise Intervention (Urban Training) Plus Therapeutic Education Programme on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in exercise capacity
研究概览
简要总结
This project plans on a community-based exercise intervention (Urban Training) combined with therapeutic education program, by using public spaces and urban walkable trails, adapted to each patient needs and capabilities in patients with chronic obstructive pulmonary disease (COPD). The main objective of the present study is to evaluate the effects comparing different levels of supervision (face-to-face vs telematic) in the short-, medium- and long-term with respect to: (primary outcome): exercise capacity, and (secondary outcomes): physical activity, quality of life, mental health and COPD exacerbations.
详细描述
It is a single-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: (1) Urban training Intervention + therapeutic education program with face-to-face supervision, (2) Urban training Intervention + therapeutic education program with telematic supervision
Each exercise training program will be applied once per day, 3 sessions per week during 12 weeks.
The group with Urban training Intervention with face-to-face supervision will be supervised by a physiotherapist once a week. The group with Urban training Intervention with telematic supervision will be supervised by a phone call once a week. To record compliance, participants from all groups were asked to complete a diary at the end of every training session.
The therapeutic education program will consisted of 1 session/week during 4 weeks.
Participants received baseline assessments at the beginning of the intervention, post-intervention assessments at the end of the 13th week, 6 months of follow-up and 12 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •COPD diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ≤ 0.70
- •Clinical stability, defined as at least 6 weeks without COPD exacerbation
排除标准
- •Neuromuscular or neurological disorders and/or psychiatric or cognitive conditions that hindered they ability to cooperate
- •Comorbidity that could interfere with study intervention (e.g., severe orthopaedic problems)
- •Previous inclusion in a rehabilitation programme (previous 6 months)
研究组 & 干预措施
Urban training Intervention + therapeutic education program with face-to-face supervision
Patients will be advised to walk in the defined urban trails with face-to-face supervision
干预措施: Urban training (Behavioral)
Urban training Intervention + therapeutic education program with telematic supervision
Patients will be advised to walk in the defined urban trails with telematic supervision
干预措施: Urban training (Behavioral)
结局指标
主要结局
Change in exercise capacity
时间窗: Baseline, post-intervention (up to 13 weeks), 6 months and 12 months
Change in exercise capacity between baseline, up to 13 weeks, 6 months and 12 months, as measured by 6-min walking distance
次要结局
- Change in physical activity(Baseline, post-intervention (up to 13 weeks), 6 months and 12 months)
- Change in quality of life(Baseline, post-intervention (up to 13 weeks), 6 months and 12 months)
- Change in anxiety and depression symptoms(Baseline, post-intervention (up to 13 weeks), 6 months and 12 months)
- COPD exacerbations(Post-intervention (up to 13 weeks), 6 months and 12 months)
研究者
Tamara del Corral Núñez-Flores
Principal Investigator
Universidad Complutense de Madrid