J44
Conditions
Interventions
Group 1: Device : KAIA COPD-App (Mobile Application).
The study intervention is an exercise training program that requires a chair and elastic bands, consisting of training elements with progressive l
Sponsors
Kaia Health Software GmbH
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
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 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 an inpatient pulmonary rehabilitation - 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 - Male and female patients between (Minimum age) and =40 years of age, Females of child bearing potential must have a negative pregnancy test prior to entry in the study - Knowledge of German language to understand study material, assessments and contents of the COPD-App
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the change in physical activity of the intervention group in comparison to the control group, measured over one week as mean steps per day comparing baseline to 6 months visit value. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes assessed are : - dyspnea (COPD-Assessment test (CAT)) - functional exercise capacity (1-minute Sit-to stand test) - HRQoL (Chronic respiratory disease questionere, CRQ) - health status (Feeling Thermometer) - HADS (Anxiety and depression scale) - Number of exacerbations (Questionnaire as defined by GOLD Guidelines) - Reaching his or her individual defined goal of physical activity - Sleep efficiency and sleep quality | — |
Countries
Germany, Switzerland
Contacts
Public ContactMarc Spielmanns
Zürcher RehaZentren Wald
Outcome results
None listed