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

Not Applicable

• Conditions: J44; J43; Other chronic obstructive pulmonary disease; Emphysema

• Registration Number: DRKS00004609
• Lead Sponsor: Klinik Bad Reichenhall

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-07
• Study Completion: 2015-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 602

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

(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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).