|- candidate number||10167|
|- NTR Number||NTR2990|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jul-2011|
|- Secondary IDs||37630 ABR nr.|
|- Public Title||Effects of inspiratory muscle training in patients with chronic obstructive pulmonary disease.|
|- Scientific Title||Effects of inspiratory muscle training in patients with chronic obstructive pulmonary disease.|
|- hypothesis||The addition of inspiratory muscle training to a general exercise training program improves inspiratory muscle strength, exercise capacity, health related quality of life and participation in daily physical activity in patients with COPD suffering from inspiratory muscle weakness. |
|- Healt Condition(s) or Problem(s) studied||COPD, Inspiratory Muscle Weakness|
|- Inclusion criteria||1. COPD;|
2. Inspiratory muscle weakness (Pimax < 60cm H2O).
|- Exclusion criteria||1. Diagnosed psychiatric or cognitive disorders;|
2. Progressive neurological or neuromuscular disorders;
3. Severe orthopedic problems having a major impact on daily activities;
4. Patients on the waiting list for lung transplantation;
5. Hospitalization during the previous month;
6. Previous inclusion in rehabilitation program (<1 year).
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-mrt-2014|
|- Target number of participants||166|
|- Interventions||Additional to general pulmonary rehabilatation prpgram: Inspiratory muscle training at a high intensity (≥ 30% PI,max), whereas the control group will receive an inspiratory muscle training intervention at a low training intensity (≤ 10% PI,max).|
|- Primary outcome||6mwd.|
|- Secondary outcome||The effects of adding IMT to a 3-months general exercise training program will be compared with a regular 3-months general exercise training program on HRQL and participation in daily physical activity in patients with COPD and inspiratory muscle weakness.|
Improvements in health-related quality of life as assessed with the disease specific chronic respiratory disease questionnaire (CRDQ) and participation in objectively assessed daily physical activity and breathing pattern during exercise will be secondary outcomes. Tidal volume (VT), inspiratory time (TI), total time of the respiratory cycle (TTOT) and respiratory frequency (fR) will be assessed as parameters reflecting breathing pattern of patients. TI/TTOT (duty cycle) represents the time fraction during which the inspiratory muscles are active. Threshold IMT is supposed to lower this fraction thereby leaving more time for expiration potentially leading to less dynamic hyperinflation. Furthermore the fR/VT ratio will be monitored to assess whether breathing during exercise becomes less rapid and less shallow after IMT.
|- Timepoints||At start and at end of rehabilatation (3 months).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. H.A.C. Helvoort, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D. Langer|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre, Department of Pulmonary diseases, Katholieke Universiteit Leuven, Faculty of Kinesiology and Rehabilitaiton Sciences Respiratory Rehabilitation |
(Source(s) of Monetary or Material Support)
|Radboud University Nijmegen Medical Centre, Department of Pulmonary diseases, Katholieke Universiteit Leuven|
|- Brief summary||Rationale: |
Respiratory muscle weakness is commonly observed in patients with COPD and contributes to reduced exercise capacity and dypnea. It is, however, still unclear if supplemental interventions to support exercise training programs such as inspiratory muscle training (IMTresult in clinically relevant improvements for patients. Meta-analyses of RCT¡¯s in patients with COPD revealed that IMT might have most beneficial effects on exercise capacity in patients with clearly reduced inspiratory muscle strength. However, the effectiveness of these interventions, when added to general exercise training programs, needs to be tested in randomized controlled trials (RCTs).
In this project the effects of adding IMT to a 3-months general exercise training program will be compared with a regular 3-months general exercise training program on exercise capacity, HRQL and participation in daily physical activity in patients with COPD and inspiratory muscle weakness. The effects of IMT on breathing pattern and symptoms of dyspnea and leg fatigue during exercise will be assessed as secondary objectives.
Randomized controlled trial, multicentre.
All patients with spirometry-proven stable COPD that are referred for outpatient pulmonary rehabilitation will be screened for inclusion. Only patients with pronounced inspiratory muscle weakness (PI,max < 60cmH2O) will be eligible to participate in the study.
Patients agreeing to participate will be randomized into an intervention and a control group. Both groups will follow a general exercise training program. The intervention group will receive an additional inspiratory muscle training program at a high intensity (≥ 30% PI,max), whereas the control group will receive an inspiratory muscle training intervention at a low training intensity (¡Ü 10% PI,max).
Main study parameters/endpoints:
Improvement in the six-minute walking distance. A clinical relevant difference in improvement of the six minute walking distance between both groups is defined as 35m.
|- Main changes (audit trail)|
|- RECORD||18-jul-2011 - 26-jul-2011|