Please select the eligibility criteria that correspond to the clinical trial below.
Title: Feasibility & Effect of a Tele-rehabilitation Program for Chronic Obstructive Pulmonary Disease vs. Standard Rehabilitation
Brief Summary: Introduction In order to guarantee chronic patients and elderly a high quality service from health care organizations in the coming decades, new technologies have been implemented to treat patients from a distance. There is still a need for more studies on the efficacy and cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be determined. To guarantee individuals with chronic obstructive pulmonary diseases (COPD) a high quality service from health care organizations in the coming decades and economically save the national health systems for an expensive bill for the treatment of COPD, new actions plans has to be taken into use. Hereby, more patients can be treated with less human resources while still sustaining or even improving today's services. The importance of such welfare action plans has to maintain a high quality of service that individuals with COPD are willing to accept. Here, TR seems to be a good welfare action plans. Despite proof of improved cost-effectiveness, no studies support the benefits of TR in COPD patient with respect to adherence, security, treatment efficacy and improved quality of life.

Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a new and innovative TR platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with COPD.

Method and material The study is a prospective randomized controlled trial comparing the effects of tele-rehabilitation and conventional rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either a 8 week tele-rehabilitation program or a conventional COPD rehabilitation program at the hospital. Participants will be tested at baseline, 8 weeks, 3 and 6 months after cessation of the training programs. In the intervention group, a real- and a virtual physiotherapist agent will facilitate the rehabilitation.

Ethical considerations This study will not pose any risk to the patient as compared to current practice. Participation is voluntary and the patient may at any time withdraw from the study without consequences for future care or treatment. The questionnaires and the test methods used are clinically recognized instruments. Signed informed consent will be obtained from the all participants after verbal and written information and before the study starts. The study will not be initiated before approval from the Ethics Committee and the Data Protection Agency has been obtained. The study will follow the general research ethical rules as expressed in the Helsinki Declaration II.


Options:
A: Inclusion Criteria:

1. Stable COPD
2. Signed informed consent
3. Completion of the standard rehabilitation program
4. Permanent oxygen therapy is not an obstacle for participation.

Exclusion Criteria:

1. The patient has significant musculoskeletal disorders that limit his / her function levels to a degree that is not caused by dyspnea
2. The patient has pronounced dizziness, significant sensory or motor disability, dementia or terminal malignant disease
3. Serious comorbidities (unstable heart disease, irregular diabetes, known malignant disease, another disease that makes the patient unfit to participate in the study).
4. Non-compliant patient (eg. Nursing Homes Residents)
5. Participation in another project within the last 30 days
6. Mini-Mental State Examination score less than 24 points
7. Severe vision or hearing loss.
8. Non-Danish speaking.
9. Lack of will to implement the protocol.
10. Motor or sensory disease, which makes it impossible for walk training
11. Have experienced a worsening in the last 4-6 weeks
12. Musculoskeletal disorders
13. Serious heart diseases (ejection fraction \<30%, daily angina, or as indicated by treating the cardiologist)
14. Can not understand informed consent
15. Other factors that inhibit the use of telerehabilitation
B: Inclusion Criteria:

* A diagnosis of COPD (FEV1/FVC \< 70% in a stable phase of the disease)
* Age \> 18 years
* Referred for conventional COPD rehabilitation
* Compliant patient willing to fulfill the study requirements
* Signed informed consent (Oxygen therapy is not an obstacle for participation).

Exclusion Criteria:

* Musculoskeletal disorders limiting training
* Dizziness, significant sensory or motor disabilities, dementia or terminal malignant disease precluding training
* Severe comorbidities such as i.e. unstable heart disease, dysregulated diabetes, known malignant disease, any other illness making the patient inappropriate for participating in the study
* Non-compliant patient
* Severe vision or hearing impairment
* Non-Danish speaking
* Unwillingness or inability to follow the protocol
* COPD exacerbation in the preceding 6 weeks
C: Inclusion Criteria:

* COPD Patients willing and able to sign informed consent for use of their pseudonymized clinical data within the scope of the present interventional trial
* COPD patients who have completed an in-hospital pulmonary rehabilitation program with an average duration of 2-3 weeks.
* 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
* Completion of the screening period and fulfilling of the randomization criteria as defined by the protocol
* Ability to use a smartphone and smartphone-apps
* Willingness to wear an activity tracker during study period of 6 months
* Patients ≥40 years of age.
* Knowledge of German language to understand study material, assessments and contents of the COPD-App

Exclusion Criteria:

* The Patient is 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 surgical or other interventions disturbing the study intervention.
* Significant psychiatric disorders, legal incapacity or limited legal capacity.
* Patients participation in another clinical trial with an investigational medication within 30 days prior to study entry.
* Patients already using the KAIA COPD App
D: Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Male and female patients ≥ 40 years of age
* Diagnosis of COPD (GOLD criteria: post bronchodilator FEV1/FVC\< 70%)
* Current or ex-smokers with a smoking history equivalent to at least 10 pack years
* Patient should have at least 4 days of physical activity data recorded via PROactive monitors during 7 days prior to the baseline measurement

Exclusion Criteria:

* Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased, then they should not be enrolled
* Respiratory diseases other than COPD (e.g. asthma)
* Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the smartphone and PDA, as judged by the investigator
* Participating in or scheduled to start an outpatient rehabilitation program during the study. If the patient wishes to participate in pulmonary rehabilitation for any reason the patient can be enrolled in the study only at the end of rehabilitation

Answer: B