Effects of 8 weeks lower-limb resistance training or lower-limb neuromuscular electrical stimulation (NMES) in severely dyspnoeic patients with chronic obstructive pulmonary disease (COPD) with lower-limb muscle dysfunction: a prospective single-blindrandomized controlled trial.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Maximum muscle strength of the leg muscles (expressed in Newton), measured with<br /><br>the Biodex. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quadriceps muscle strength<br /><br>- Exercise tolerance<br /><br>- Body composition<br /><br>- MRC dyspnoe grade<br /><br>- Lungfunction<br /><br>- Quality of Life (St. George's Respiratory Questionnaire)<br /><br>- Adverse events (inclusive acute COPD exacerbations)<br /><br>- Number of drop-outs<br /><br>- Total level of daily physical activity (using a validated accelerometer )<br /><br>- Oxygen uptake and ventilation<br /><br>- Compliance rate<br /><br>- Changes in vastus lateralis fibre type shift, fibre cross sectional area and<br /><br>aerobic enzyme activity.</p><br>