Efficiency of inspiratory muscle Training (IMT) as an adjunct to pulmonary Rehabilitation (PR) in patients with COPD. A randomised, placebo controlled, single blinded study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004609

Enrollment

420

Registered

2013-01-07

Start date

2013-02-01

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

J44 J43

Interventions

Group 1: Group "blue": Standard pulmonary Rehabilitation program + IMT (method threshold loading). Standard pulmonary rehabilitation program = 3 weeks. IMT 21 minutes/day Group 2: group "violet": stan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients undergoing the at least 3 week inpatient pulmonary Rehabilitation program with a diagnosis of COPD (GOLD II-IV). Patients with hypercapnic respiratory failure - CO2 up to 50 mm Hg or more - are not included.

Exclusion criteria

Exclusion criteria: (1) linguistic or cognitive constraints that limit participation and lack of motivation (2) severe comorbidities that superimpose the results of the outcome criteria in a relevant way; e.g. Tumor, severe cardial or orthopaedic comorbidities, obesity hypoventilation syndrome (3) hypercapnic respiratory failure (CO2 up to 50 mmHg or more under resting conditions or indicated for intermittent noninvasive Ventilation (4) decline of written consent

Design outcomes

Primary

Measure	Time frame
MIP = PI max: Maximum inspiratory pressure [kPa]; TO (start of rehabilitation), T1 (end of rehabilitation). The measurement is performed with a commercially available mouth occlusion pressure gauge made ??by CareFusion following the recommendations of the German Airway League.	—

Secondary

Measure	Time frame
6-minute walk distance (6-MWD, [m], T0, T1). shortness of breath questionnaires (dyspnoea scale of the Medical Research Council, MRC dyspnoea scale), dyspnoea indices (Transition Dyspnoea Index (TDI) and Baseline Dyspnoea Index / Transitional Dyspnoea Index (BDI / TDI), To, T1, T2 (3 months after rehab), T3 (6 months after rehab), T4 (12 months after rehab); subjective health status (COPD Assessment test, CAT), COPD Disability Index (CDI), generic quality of life (SF 36), disease-specific quality of life (St. George's Respiratory Questionnaire, SGRQ), Clinical COPD Questionnaire, CCQ) T0-T4, lost work days and hospital days (T2-4), number of retirements in the year after rehabilitation (T4).	—

Measure

Time frame

6-minute walk distance (6-MWD, [m], T0, T1). shortness of breath questionnaires (dyspnoea scale of the Medical Research Council, MRC dyspnoea scale), dyspnoea indices (Transition Dyspnoea Index (TDI) and Baseline Dyspnoea Index / Transitional Dyspnoea Index (BDI / TDI), To, T1, T2 (3 months after rehab), T3 (6 months after rehab), T4 (12 months after rehab); subjective health status (COPD Assessment test, CAT), COPD Disability Index (CDI), generic quality of life (SF 36), disease-specific quality of life (St. George's Respiratory Questionnaire, SGRQ), Clinical COPD Questionnaire, CCQ) T0-T4, lost work days and hospital days (T2-4), number of retirements in the year after rehabilitation (T4).

—

Countries

Germany

Contacts

Public ContactKonrad Schultz

Klinik Bad Reichenhall

konrad.schultz@klinik-bad-reichenhall.de00498651709535

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026