The purposes of this study are to study the effects of low-frequency NMES, high-frequency NMES and resistance training on health status, exercise tolerance and muscle strength in patients with COPD.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximum muscle strength of the leg muscles (expressed in Newton), measured with
the Biodex.
Secondary outcome
- Quadriceps muscle strength
- Exercise tolerance
- Body composition
- MRC dyspnoe grade
- Lungfunction
- Quality of Life (St. George's Respiratory Questionnaire)
- Adverse events (inclusive acute COPD exacerbations)
- Number of drop-outs
- Total level of daily physical activity (using a validated accelerometer )
- Oxygen uptake and ventilation
- Compliance rate
- Changes in vastus lateralis fibre type shift, fibre cross sectional area and
aerobic enzyme activity.
Background summary
Patients with Chronic Obstructive Pulmonary Disease (COPD) experience dyspnoea
and fatigue durig daily physical activity, in spite of an optimal
pharmacological treatment. Pulmonary rehabilitation can improve these symptoms.
Unfortunately, not every patient with COPD is able to complete conventional
training methods, due to exercise-induced dyspnoea. Resistance training and
transcutaneous neuromuscular electrical stimulation are relative new training
modalities in patient with COPD, which have shown to have positive effects on
skeletal muscle function, exercise tolerance and health-related quality of
life. To date, only high-frequency (> 50 Herz) is used. It is plausible to use
low-frequency NMES (15 Herz) also, because of the decreased exercise tolerance.
Study objective
The purposes of this study are to study the effects of low-frequency NMES,
high-frequency NMES and resistance training on health status, exercise
tolerance and muscle strength in patients with COPD.
Study design
It concerns a prospective, single-blind randomized controlled trial.
Intervention
Resistance training of the lower-limb muscles.
Low-frequency (15 Herz) and high-frequency (75 Herz) transcutaneous electrical
stimulation of the lower-limbs.
Study burden and risks
All interventions will be given at Ciro Horn as part of the regular clinical
pulmonary rehabilitationprogramm.
The burden concerning the intervention is not more than in the regular
pulmonary rehabilitationbecause of the shift towards interventions which cause
less dyspnoea for the patients.
P. Debeyelaan 25
6202 AZ Maastricht
NL
P. Debeyelaan 25
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
• Patients with a primary diagnosis of COPD according to the Global Initiative For Chronic Obstructive Pulmonary Lung Disease (GOLD) definition: Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible.The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases. COPD is diagnosed by a chest physician.
• Medical Research Council dyspnea scale (MRC) 4/5. COPD patients with grade 4 or 5 on the Medical Research Council (MRC) dyspnoea scale (*stops for breath after walking about 100 yards or after a few minutes on level ground* or *too breathless to leave the house, or too breathless when dressing or undressing*, respectively) have been shown to have a higher risk of having quadriceps weakness compared to COPD patients with lower MRC dyspnoea grades, even after correction for the degree of airflow limitation. Almost 50% of the patients with MRC dyspnoea grade 4 or 5 has quadriceps weakness. Moreover, exercise intolerance and reduced health status have been related to higher MRC dyspnoea grades in patients with COPD.
• Muscle weakness of the lower limbs. Muscle strength and endurance will be measured with the Biodex.
• Informed consent for voluntary participation.
• To be able to communicate in the Dutch language.
Exclusion criteria
• Neuromuscular disorders. In neuromuscular disorders a (partial) paralysis will have consequences for the conductance speed of the nerves. The parameters of the treatment by NMES, which are mentioned in the research-protocol, can differ from the parameters which are necessary at neuromuscular disorders
• Joint disorders in hip, leg and/or knee. Probably these disorders need a different kind of therapy (for example water therapy). Thereby these disorders can ensure confounders in the measurements which to take place in the assessment.
• Metal implants in hip, leg and/or knee. Metal implants cause a disruption of the electric field. The field lines concentrate on metal. As a consequence overheating and damaging of the tissues around the metal can take place.
• Cardiac pacemaker or Internal Cardiac Defibrillator (ICD). Although the presence of safety studies patients with implantated pacemakers and ICDs will be excluded.
• Lack of motivation to participate voluntarily in this study.
• Patiënten with chronic oxygen suppletion will be xcluded for the measurements with the Oxycon Mobile.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL30153.068.09 |
| OMON | NL-OMON23227 |