|- candidate number||6694|
|- NTR Number||NTR2092|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-nov-2009|
|- Secondary IDs||09-114/K METC UMC Utrecht|
|- Public Title||Inspiratory muscle training prior to peripheral muscle training in children and adolescents with Cystic Fibrosis.|
|- Scientific Title||Inspiratory muscle training prior to peripheral muscle training in children and adolescents with Cystic Fibrosis.|
|- ACRONYM||IMT in children and adolescents with Cystic Fibrosis|
|- hypothesis||A home-based peripheral muscle training program (Five Basic Exercises program (5BX)) is more effective in [a] increasing exercise capacity (e.g. peak work rate) and [b] patients’ preferred occupational performance when it is preconditioned by inspiratory muscle training (IMT).|
|- Healt Condition(s) or Problem(s) studied||Cystic Fibrosis (CF), , Inspiratory muscles, Excercise capacity|
|- Inclusion criteria||1. Ambulant patients with CF; |
2. Age: range from 12 to 18 years of age.
|- Exclusion criteria||1. Gastro-intestinal or pulmonary exacerbation (extra oral or intravenous antibiotics for the past four weeks) at inclusion;|
2. Oxygen saturation (SpO2) < 90% (without O2 supply);
3. Ineligible to perform CPET;
4. Not familiar with the Dutch language;
6. Participation in study “MOVIT” less than one year ago. Patients can enter the protocol one year after finishing participation in “MOVIT”.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2009|
|- planned closingdate||1-sep-2013|
|- Target number of participants||60|
|- Interventions||Both groups receive inspiratory muscle training (IMT) or sham (placebo)-IMT based on randomization. IMT last for 6 weeks, 5 days a week, 11 minutes a day.|
After IMT or sham-IMT, both groups receive a standardized peripheral muscle training programme (5 Basic eXercises (5BX)) for 6 weeks, 5 days a week, 11 minutes a day.
|- Primary outcome||Peak workload attained during cardiopulmonary exercise testing.|
|- Secondary outcome||1. Exercise capacity;|
2. Respiratory muscle function;
3. Peripheral muscle function;
4. Habitual daily activity;
5. Rate of perceived excertion;
6. Patients preferred ocupational performance;
9. Use of medication and other care;
10. Health related quality of life.
|- Timepoints||1. t= 0 (baseline);|
2. t= 6 weeks;
3. t= 12 weeks;
4. t= 18 weeks;
5. t= 24 weeks.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| H.J. Hulzebos|
|- CONTACT for SCIENTIFIC QUERIES|| H.J. Hulzebos|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Kon. Ned. Genootschap voor Fysiotherapie|
|- Brief summary||Cystic fibrosis (CF) primarily affects the respiratory and digestive systems in children and young adults. Due to the continual bronchial airway obstruction a chronic hyperinflation of the thorax develops, thereby decreasing the efficiency of inspiratory muscle work and increasing work of breathing (WOB) in rest and during exercise. The increased WOB and the corresponding fatigue of the inspiratory muscles (diaphragm and supportive inspiratory muscles) are thought to induce a so called ‘respiratory muscle induced metaboreflex’ causing a reflex vasoconstriction of the locomotor muscle blood vessels. It is feasible that this decreased blood supply to the locomotor muscles will limit exercise capacity.
The hypothesis of this study is therefore: A home-based peripheral muscle training program (Five Basic Exercises program (5BX)) is more effective in [a] increasing exercise capacity (e.g. peak work rate) and [b] patients’ preferred occupational performance when it is preconditioned by inspiratory muscle training (IMT).
|- Main changes (audit trail)|
|- RECORD||4-nov-2009 - 23-mei-2010|