J44
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of chronic obstructive pulmonary disease (COPD), all severity grades (GOLD stages I–IV and ABE classification). - Medical indication for pulmonary rehabilitation. - Positive rehabilitation prognosis, i.e. functional impairment justifies referral and the patient is considered suitable for rehabilitation. - Approved rehabilitation application and assignment to one of the participating study centers. - Sufficient German language skills (reading and writing) to complete the questionnaires. - Written informed consent to participate in the study and agreement to pseudonymized data processing. • Presence of COPD with a medical indication for pulmonary rehabilitation. • A positive prognosis for rehabilitation, whereby the functional limitation of the patient is the decisive criterion for prescribing rehabilitation. • An approved rehabilitation application and an assigned place at one of the study centres described. • Sufficient written and spoken German language skills to complete the questionnaires. • Consent to participate in the study and agreement to pseudonymised data processing.
Exclusion criteria
Exclusion criteria: - Acute or decompensated medical conditions that preclude rehabilitation. - Acute infectious diseases or inflammatory processes. - Need for nursing care. - Drug dependence or alcohol abuse. - Patients who are not sufficiently resilient or mobile due to physical or psychological/mental impairments, such that rehabilitation measures would not provide active benefit. - Current participation in other studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in functional status, assessed by the 6-Minute Walk Test (6MWT), between baseline (T1: admission) and post-intervention (T2: discharge), validated using the Global Rating of Change Scale (GRS) as anchor instrument. 2. Change in health-related quality of life, assessed by the EQ-5D-5L, between baseline (T1) and post-intervention (T2), validated using the Global Rating of Change Scale (GRS) as anchor instrument. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in dyspnea severity, assessed by the modified Medical Research Council scale (mMRC), from admission (T1) to discharge (T2). 2. Change in multidimensional COPD severity, assessed by the BODE index, from T1 to T2. 3. Change in pulmonary function (FEV1 %, FEV1/FVC %, RV %, DLCO %, TLC), measured by standardized spirometry/body plethysmography, from T1 to T2. 4. Change in functional capacity, assessed by the 1-Minute Sit-to-Stand test (1MSTS; repetitions), from T1 to T2. 5. Change in functioning and disability, assessed by the ICF Core Set for COPD, from T1 to T2. 6. Change in anxiety and depression, assessed by the Hospital Anxiety and Depression Scale (HADS), from T1 to T2. 7. Change in epistemic trust, assessed by the Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ), from T1 to T2. | — |
Countries
Austria, Germany, Switzerland
Contacts
Ludwig Boltzmann Institute for Rehabilitation Research