Effectiveness of Pulmonary Rehabilitation in Patients with asthma ("EPRA study") - A prospective randomized intervention study (waiting group design)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007740

Enrollment

503

Registered

2015-05-15

Start date

2015-06-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

J45

Interventions

Group 1: Prospective randomized intervention study with waiting group design. The intervention group undergoes a 3-week multimodal inpatient pulmonary rehabilitation 4 weeks after rehab authorization

Eligibility

Sex/Gender

All

Age

18 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. All rehabilitation patients with leading diagnosis Asthma (= rehabilitation diagnosis) 2nd and lack of asthma control (ACT = 19 points) 3rd and Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with a lack of language skills and / or 2. lacking cognitive ability and / or 3. severe comorbid diseases that overlay the results of the outcome parameters relevant and clinically leading (e. g. tumors, severe cardiac, orthopedic and psychological comorbidities)

Design outcomes

Primary

Measure	Time frame
Primary Outcome = asthma control. This is measured by the Asthma Control Test (ACT; Schatz et al., 2006) at T0, T1, T2 and T3 (parallel in the IG and CG = RCT). At the measurement times T4-T8 the results of the two groups will be pooled and analyzed the sense of an observational study (1 year follow-up). IG: T0 = baseline = rehab permission (1 month before starting with rehab), T1 = Beginning of rehabilitation, T2 = End of rehabilitation (duration 3 weeks), T3, T4, T5, T6 = 3, 6, 9 and 12 months after discharge from rehab. GC (passes the same rehab, but starts 4 months later). T0 = baseline, T1 = 4 months prior to rehabilitation, T2 = 3 months prior to rehabilitation, T3 = start of rehabilitation (duration 3 weeks), T4 = end of rehabilitation; T5-T8 = 3, 6, 9 and 12 months after the end of rehabilitation.	—

Measure

Time frame

Primary Outcome = asthma control. This is measured by the Asthma Control Test (ACT; Schatz et al., 2006) at T0, T1, T2 and T3 (parallel in the IG and CG = RCT). At the measurement times T4-T8 the results of the two groups will be pooled and analyzed the sense of an observational study (1 year follow-up). IG: T0 = baseline = rehab permission (1 month before starting with rehab), T1 = Beginning of rehabilitation, T2 = End of rehabilitation (duration 3 weeks), T3, T4, T5, T6 = 3, 6, 9 and 12 months after discharge from rehab. GC (passes the same rehab, but starts 4 months later). T0 = baseline, T1 = 4 months prior to rehabilitation, T2 = 3 months prior to rehabilitation, T3 = start of rehabilitation (duration 3 weeks), T4 = end of rehabilitation; T5-T8 = 3, 6, 9 and 12 months after the end of rehabilitation.

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Secondary

Measure	Time frame
Health-related quality of life (SGRQ, AQLQ, EQ-5D-5L), symptoms: dyspnea, cough, sputum, pain (numeric rating scales), GROC-scale, physical fitness (6MWT), psychological distress by anxiety and depression (PHQ-D, GAD7, IPQR , BFI, Nijmegen questionnaire), self-management skills (HeiQ, MARS-D, BMQ), smoking (self developed questionnaire), utilization and costs of health services (FIM Lu, WAI, SPE), number of cortisone courses and / or antibiotic therapies (self developed questionnaire). Secondary endpoints are measured at T0 - T8. Abbreviations: Asthma Control Test (ACT) Saint George's Respiratory Questionnaire (SGRQ) Asthma Quality of Life Questionnaire (AQLQ) Health questionnaire EQ-5D-5L GROC-scale (global rating of change scale) Patient Health Questionnaire (PHQ) [] Generalized Anxiety Disorder Questionnaire (GAD 7) Brief Fatigue Inventory (BFI) SPE-scale Work Ability Index - questionnaire (WAI) Item 1 and 4 Health Education Impact Questionnaire (HeiQ) Item 1 and 3 Revised Illness Perception Questionnaire (IPQ-R) NQ = Nijmegen Questionnaire FIM Lu, modification of FIMA Brief Medication Questionnaire (BMQ) Medication Adherence Report Scale (MARS)	—

Measure

Time frame

Health-related quality of life (SGRQ, AQLQ, EQ-5D-5L), symptoms: dyspnea, cough, sputum, pain (numeric rating scales), GROC-scale, physical fitness (6MWT), psychological distress by anxiety and depression (PHQ-D, GAD7, IPQR , BFI, Nijmegen questionnaire), self-management skills (HeiQ, MARS-D, BMQ), smoking (self developed questionnaire), utilization and costs of health services (FIM Lu, WAI, SPE), number of cortisone courses and / or antibiotic therapies (self developed questionnaire). Secondary endpoints are measured at T0 - T8. Abbreviations: Asthma Control Test (ACT) Saint George's Respiratory Questionnaire (SGRQ) Asthma Quality of Life Questionnaire (AQLQ) Health questionnaire EQ-5D-5L GROC-scale (global rating of change scale) Patient Health Questionnaire (PHQ) [] Generalized Anxiety Disorder Questionnaire (GAD 7) Brief Fatigue Inventory (BFI) SPE-scale Work Ability Index - questionnaire (WAI) Item 1 and 4 Health Education Impact Questionnaire (HeiQ) Item 1 and 3 Revised Illness Perception Questionnaire (IPQ-R) NQ = Nijmegen Questionnaire FIM Lu, modification of FIMA Brief Medication Questionnaire (BMQ) Medication Adherence Report Scale (MARS)

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Countries

Germany

Contacts

Public ContactKonrad Schultz

Klinik Bad Reichenhall der DRV Bayern Süd

konrad.schultz@klinik-bad-reichenhall.de08651709535

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 10, 2026