Please select the eligibility criteria that correspond to the clinical trial below.
Title: Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up
Brief Summary: Introduction In order to guarantee chronic patients \& 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 a follow-up tele-rehabilitation program and conventional follow-up rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either an 8 week follow-up tele-rehabilitation program or to standard follow up after rehabilitation. Participants will be tested at baseline, after 8 weeks 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:

* Participants will have:

  1. a diagnosis of COPD which is clinically stable (including medications) for at least one month;
  2. spirometry results showing at least mild obstructive disease defined as post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio \<0.70 with FEV1\<80% predicted or post-bronchodilator FEV1/FVC ratio \<0.60 with FEV1\>80% predicted;
  3. ADL limited by dyspnea;
  4. a designated primary care physician;
  5. ability to speak English and sign consent form;
  6. actively using a computer and the Internet;
  7. no formal pulmonary rehabilitation training for at least 12 months;
  8. patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at \>80% on \<6L/min of nasal oxygen;
  9. understands how to and is able to rate their shortness of breath during exercise;
  10. age \> 40 years.

Exclusion Criteria:

* Subjects will be excluded if they have active symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease with known coronary artery or valvular heart disease, psychiatric illness, and neuromuscular disease).
B: Inclusion Criteria:

* Patients diagnosed with COPD according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) creteria.
* Presence of an incompletely reversible obstructive ventilatory disorder defined by a report VEMS / CVF lower than the lower limit of normal post-bronchodilator.
* Patient on RR for four weeks in respiratory rehabilitation center.
* Aged between 40 and 78 years.

Exclusion Criteria:

* Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
* Patients with significant and unstable cardiovascular disease.
* Inability to understand and/or answer questionnaires.
* Refusal to use a smartphone or digital device.
* Unable to access an internet connection at home.
C: 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
D: Inclusion Criteria:

* severe and very severe COPD (i.e. with an FEV1 (forced expiratory volume in 1 second) value under 50% of the predicted value, an FEV1/FVC (forced vital capacity) ratio \< 70%, MRC (Medical Research Council Dyspnoea Scale) grade 3)
* ≥40 years
* hospitalization with exacerbation of COPD
* declined participation in the hospital based rehabilitation
* participation in videoconference sessions with a nurse for one week immediately after discharge.

Exclusion Criteria:

* inability to communicate via telephone and computer
* systolic BP \<100mm Hg
* X-rays of the thorax showing abnormalities suspicious of thoracic malignancy or lobar pneumonia
* a diagnosis of cancer or recurrence of cancer within the last 5 years
* hospitalization with septic shock, acute myocardial infarction (AMI) or other serious medical conditions (e.g. kidney disorder)
* heart failure (EF\<30%)
* if the patient did not wish to participate.

Answer: C