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Prospective multicentre study of the baseline dependence of minimal clinically significant differences in patients with chronic obstructive pulmonary disease

Prospective multicentre study of the baseline dependence of minimal clinically significant differences in patients with chronic obstructive pulmonary disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037860
Enrollment
500
Registered
2025-09-10
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J44

Interventions

Group 1: Patients with chronic obstructive pulmonary disease (COPD) participate in inpatient or outpatient rehabilitation (duration 3 to 24 weeks, depending on the setting). Routine data (e.g., 6-Minu

Sponsors

Ludwig Boltzmann Institute for Rehabilitation Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

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

MeasureTime 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

MeasureTime 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

Public ContactVincent Grote

Ludwig Boltzmann Institute for Rehabilitation Research

vincent.grote@lbg.ac.at+431361522012

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026