Evidence Based Training and Physical Activity With an E-health Program - a New Method for People With Chronic Obstructive Pulmonary Disease (COPD) to Become More Physically Active.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- COPD Assessment Test, CAT, to assess symtoms of COPD
研究概览
简要总结
The main aim of the project in this application is two-fold. First we will explore and describe facilitators and barriers for being physically active and perform physical training for people with Chronic Obstructive Pulmonary Disease COPD (Step 1). Secondly, with user involvement, we will develop and evaluate a novel e-health program with a training module and an evidence-based educational component, the rEACH-COPD e-health program with the aim to increase the understanding and management of the disease and to facilitate every-day living with COPD (Step 2-3).
According to the guidelines of the Swedish National Board of Health and Welfare (SoS), physiotherapy led exercise is an important part of rehabilitation for people with COPD. The e-health training program will follow evidence-based guidelines, i.e. recommendations from SoS and the American College of Sport Medicine (ACSMS).
Offering individualized and evidence-based training will increase adherence to training. With regular physical activity and exercise there is a potential to improve health-related quality of life, physical capacity, activity and participation in every day life in people with COPD.
By an improved health, physical function and quality of life a decreased use of health care is expected. Thus, this program may, in the long term, contribute to reduced costs for the society.
详细描述
There is convincing evidence that physical activity and exercise have positive effects on quality of life and health in people with chronic disease and/or disabilities, but training programs do not reach all in need for it. Being able to offer individualized evidence-based training with modern technology (e-health) is an option, that may increase participation in health enhancing physical activity in people with chronic diseases.
The main aim of the project in this application is two-fold. First we will explore and describe facilitators and barriers for being physically active and perform physical training for people with Chronic Obstructive Pulmonary Disease COPD (Step 1). Secondly, with user involvement, we will develop and evaluate a novel e-health program with a training module and an evidence-based educational component, the rEACH-COPD e-health program with the aim to increase the understanding and management of the disease and to facilitate every-day living with COPD (Step 2-3).
Participants will be recruited from both Stockholm and Västerbotten county, university hospitals and primary care.
According to the guidelines of the Swedish National Board of Health and Welfare (SoS), physiotherapy led exercise is an important part of rehabilitation for people with COPD. The e-health training program will follow evidence-based guidelines, i.e. recommendations from SoS and the American College of Sport Medicine (ACSMS).
The e-health program will be developed and launched during 2019 and the participants will be included in the development to make the product feasible for the end users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •participants must have a diagnosed COPD, be over 40 years and have no other medical barriers to participate in training at home with the e-health program.
排除标准
- •medical barriers to participate in training at home with the e-health program.
研究组 & 干预措施
Intervention
Training with e-health product The training program follows the recommendations for training from ACSMS and SoS who states the importance that exercise programs should include muscle strengthening, cardiovascular as wells as balance exercises. Therefore, the training program includes: Strengthening exercises for the upper and lower extremities (number: 5-8 pc. with progression in three levels), daily (5-7 times / week), 30 minutes walks and balance training.
干预措施: Training with e-health product (Other)
Control
usual care, i.e. participates in regular training regime at the physiotherapy department
干预措施: Usual care (Other)
结局指标
主要结局
COPD Assessment Test, CAT, to assess symtoms of COPD
时间窗: Assess change from baseline to 10 weeks, 6 month and 12 month follow-up
Questionnaire with 8 questions, graded 0-5. Total sum range from 0-40. High scores indicate high prevalence of symtoms.
次要结局
- EuroQoL (EQ5D) assess health-related quality of life(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- Leicester Cough Questionnaire LCQ-S assess health-related quality of life related to cough(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- mMRC (Medical Research Council Scale) assess symtoms of COPD(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- the Hospital anxiety and depression Scale, HAD, assess anxiety and depression(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- The SCI Exercise Self-Efficacy Scale assess Self-efficacy of their own ability to cope with physical activities(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- Frändin Grimby scale to assess Physical activity level(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- Accelerometer to assess physical activity level and pattern(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- MiniBESTest asses balance performance(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- The Activities-specific Balance Confidence scale (ABC scale) assess balance confidence(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- 6-minute walk test to assess physical performance(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- Sit to stand test to assess muscle strength in the lower leg.(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- 10 meter walking test to assess walking speed.(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- Hand grip test to assess hand grip strength(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
- Fall efficacy scale international (FES-I) to assess concerns about falling(Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
研究者
Alexandra Halvarsson
Principal Investigator
Karolinska Institutet