J44
Conditions
Interventions
Group 1: Access to Breathment Therapy App with personalized pneumology rehabilitation plan (3-7 days/week) and 2 video therapy sessions.
Group 2: Active control group: self-directed physical training,
Sponsors
Breathment GmbH
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: The target group is male and female COPD patients after exacerbation-related inpatient stay, >/= 40 years of all COPD stages and all health insurance companies with access to a smartphone and the competence to use an app. Women of childbearing age must have a negative pregnancy test prior to entering the study COPD patients who are willing and able to sign an informed consent form for the use of their pseudonymized clinical data in this intervention study 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 fulfillment of randomization criteria specified in the protocol Ability to use a smartphone and smartphone apps Knowledge of the German language to understand study materials, assessments, and therapy app content.
Exclusion criteria
Exclusion criteria: Patient* is unable to complete the training program for physical, cognitive, or safety reasons as determined by the investigator, e.g., lower extremity joint surgery within the past three months, unstable cardiac disease, prevalent neurological limitations, planned surgical procedures, or other interventions that interfere with the study intervention.Lack of German language skills Lack of ability to use e-health technologies.Significant psychiatric disorders, immaturity, or impaired judgment. Participation in another clinical trial with an investigational drug within 30 days prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The two primary endpoints are dyspnea measured by COPD Assesment Test (CAT) score and physical performance measured by the repetition number of the 1-minute sit-to-stand test [time frame: Baseline at the beginning of the intervention (day 0); beginning of the second half (week 4); end of the intervention (week 8); end of the observation period (week 20)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| All other endpoints are secondary endpoints. These will be evaluated at regular intervals during the study and after a follow-up period 12 weeks after baseline measurement. The secondary endpoints are: Quality of life measured by "Chronic Respiratory Disease Questionnaire" (SAS-CRQ). Number of steps per day as mean over one week from baseline Subjective health status measured by feeling thermometer scale Incidence and duration of patient-reported exacerbations Incidence and duration of hospitalizations Ease of use assessment Rate, number and severity of device defects Rate, number and severity of adverse events | — |
Countries
Germany
Contacts
Public ContactSarah-Christin Mavi
Asklepios-Fachkliniken München Gauting
Outcome results
None listed