No registrations found.
ID
Source
Brief title
Health condition
inspiratory muscles (inademhaling spieren)
training
Cystic Fibrosis (taaislijmziekte)
exercise capacity (inspanningsvermogen)
Sponsors and support
Intervention
Outcome measures
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;
7. Spirometry;
8. Anthropometry;
9. Use of medication and other care;
10. Health related quality of life.
Background 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).
Study objective
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).
Study design
1. t= 0 (baseline);
2. t= 6 weeks;
3. t= 12 weeks;
4. t= 18 weeks;
5. t= 24 weeks.
Intervention
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.
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;
5. Pneumothorax;
6. Participation in study “MOVIT” less than one year ago. Patients can enter the protocol one year after finishing participation in “MOVIT”.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1975 |
| NTR-old | NTR2092 |
| Other | METC UMC Utrecht : 09-114/K |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |