|- candidate number||5835|
|- NTR Number||NTR1834|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mei-2009|
|- Secondary IDs||NL25877.068.08 MEC AZM/UM |
|- Public Title||The metabolic response during NMES in patients with COPD.|
|- Scientific Title||The metabolic response during low-frequent and high-frequent neuromuscular electrical stimulation of the quadriceps muscles in patients with chronic obstructive pulmonary disease.|
|- ACRONYM||The metabolic response during NMES in patients with COPD|
|- hypothesis||H0: The metabolic respons and symptom perception (expressed in borgscores for dyspnoea and fatigue) is equal or below during low-frequent neuromuscular electrical stimulation compared with high-frequent neuromuscular electrical stimulation. |
H1: The metabolic respons and symptom perception (expressed in borgscores for dyspnoea and fatigue) is higher during low-frequent neuromuscular electrical stimulation compared with high-frequent neuromuscular electrical stimulation.
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD)|
|- Inclusion criteria||1. COPD according the Global Initiative For Chronic Obstructive Pulmonary Lung Disease (GOLD) definition;|
2. Clinical stable patients;
3. Voluntary authorisation for paricipation.
|- Exclusion criteria||1. Neuromuscular diseases;|
2. Long-term oxygen therapy;
3. Disorders or metal implants in hip, leg and/or knee;
4. Cardiac pacemaker;
5. Demotivated to participate in the study;
6. No exacerbation 4 weeks before participation at the study.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||18-mei-2009|
|- planned closingdate||1-jul-2009|
|- Target number of participants||15|
|- Interventions||Design and procedures: |
This is a prospective cross-sectional, comparative study. A physiotherapist will recruit the patients of a rehabilitation program at the Centre for Integrated Rehabilitation of Organ Failure (CIRO) in Horn, The Netherlands. After study enrolment, all patients will undergo one session of low-frequency NMES and one session of high-frequency NMES on two separate days within the same week, in random order. Randomization will be performed by means of a computer generated randomization list. Pulmonary function, body composition (dual-energy X-ray absorptiometry), peak cycling load, peak aerobic capacity, Borg symptom scores for dyspnoea and fatigue and the Medical Research Council dyspnoea grade will be determined at baseline.
During the NMES, the quadriceps femoris muscles of both legs will be electrically stimulated with a portable electrical stimulator (Gymnex 4, Gymna Uniphy N,V., Bilzen, Belgium). A total of 8 electrodes will be placed on the quadriceps femoris muscles (4 on each leg): two on the vastus medialis and two on the rectus femoris muscles and the vastus lateralis muscle. The stimulation protocol of the low-frequency NMES will consist of a symmetrical biphasic square pulse at 15 Hz, a duty cycle of 8 seconds on and 2 seconds off, a pulse time of 390 microseconds, intensity adjusted to individual toleration during a session lasting 29 minutes. The stimulation protocol of the high-frequency NMES will consist of a symmetrical biphasic square pulse at 75 Hz, a duty cycle of 6 seconds on and 29 seconds off, a pulse time of 410 microseconds, intensity will be adjusted to individual toleration during a session lasting 21 minutes.
During the NMES on-line calculations of breath-by-breath oxygen uptake (VO2) and minute ventilation (VE) will be obtained using the Oxycon mobile (VIASYS Healthcare, the Netherlands), a portable metabolic system. A face mask will be carefully adjusted to the patients face and checked for air leaks. The methodology used to assess the metabolic response has been described in detail elsewhere (Probst et al, ERJ 2006). Additionally, Borg symptom scores for dyspnoea and leg fatigue will be obtained before and after both NMES sessions.
|- Primary outcome||Oygen uptake (VO2) and ventilation (VE).|
|- Secondary outcome||Borgscores for dyspnoea and fatigue in the legs.|
|- Timepoints||Primary and secondary outcomes after one day and after two days.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M. Sillen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Martijn A. Spruit|
|- Sponsor/Initiator ||Centrum voor Integrale Revalidatie Orgaanfalen|
(Source(s) of Monetary or Material Support)
|Centrum voor Integrale Revalidatie Orgaanfalen|
|- Brief summary||Background of the study:|
Patients with chronic obstructive pulmonary disease (COPD) still suffer from disabling dyspnoea, fatigue and exercise intolerance in daily life despite optimal drug treatment. Unfortunately, not every COPD patient is able to complete conventional training methods, due to exercise-induced dyspnoea. Transcutaneous neuromuscular electrical stimulation (NMES) is a relative new treatment modality, which has been shown to have positive effects on skeletal muscle function, exercise tolerance and disease-specific health status in patients with COPD.
Objective of the study:
Comparing the metabolic response (oxygenuptake and ventilation) and symptom perception (borgscores for dyspnoea and fatigue) between neuromuscular electrical stimulation with low-frequency and high-frequency.
A prospective cross-over intervention study design.
The study population exists of patients with COPD.
Neuromuscular electrical stimulation
Primary study parameters/outcome of the study:
1. Oxygen uptake (VO2);
2. Ventilation (VE).
Secundary study parameters/outcome of the study:
1. Borgscores for dyspnoea before and after the electrical stimulation;
2. Borgscores for fatigue of the leg muscles before and after the electrical stimulation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The current research group believes that the nature and possible extent of the burden and risks possibly related to the present protocol are nihil and acceptable. Neuromuscular electrical stimulation had been used in previous studies (Neder et al, Thorax 2002; Bourjeily-Habr, Thorax 2002) and in daily routine without any adverse events.
The mobile oxycon had been used in previous studies in healthy subjects and patients with moderate to very severe COPD during exercise tests (for example: Probst et al, Chest 2004) and during extensive rehabolitation sessions (Probste et al, CERJ 2006) without any adverse events.
|- Main changes (audit trail)|
|- RECORD||25-mei-2009 - 30-sep-2009|