Investigating the effect of bilateral quadriceps NeuroMuscular Electrical Stimulation (NMES) on exercise capacity in patients with severe chronic obstructive pulmonary disease

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2012
INTERVENTION: Active, NMES to the quadriceps for 30min daily for 6 weeks (frequency 50Hz, pulse width 350µs, duty cycle 11‐50%, amplitude 0‐120mA over 1000O). The proportion of the treatment duration which is active, i.e. the stimulation phase of the duty cycle, will increase on a weekly basis from 11% to 25% to 50%, remaining constant thereafter. Control, Placebo NMES to the quadriceps for 30min daily for 6 weeks using levels of stimulation detectable by the patient but not able to elicit a tetanic muscle contraction (frequency 50Hz, pulse width 350µs, duty cycle 11‐50%, amplitude 0‐20mA). CONDITION: Chronic obstructive pulmonary disease ; Respiratory ; Other chronic obstructive pulmonary disease PRIMARY OUTCOME: Six‐minute walk test (6MWT) at baseline, 6 and 12 weeks SECONDARY OUTCOME: 1. Quadriceps function and size; assessed by quadriceps maximum voluntary contraction and twitch with femoral nerve stimulation, time for twitch to decline to 70% of maximum with repetitive transcutaneous stimulation, rectus femoris cross sectional area with ultrasonography and fat free mass by bioimpedence (kg).; 2. Exercise capacity: assessed by 6MWT distance (m) at 12 weeks; 3. Physical activity level: mean daily step count, up/down transitions and time spent upright; 4. Health‐related quality of life; overall health on EQ5D visual analogue scale (0‐100), St Georges; 5. Respiratory Questionnaire and Chronic Respiratoary Disease Questionnaire; 6. Service utilisation; formal and informal care 12 weeks assessed by Client Service Reciept Inventory; 7. Patients' experiences: semi‐structured interviews in a sub‐group of patients at 6 weeks INCLUSION CRITERIA: 1. >=18 years of age 2. Diagnosis of COPD [ forced expiratory volume in the first one second to the forced vital capacity of the lungs (FEV1: FVC ratio <=70%)] 3. Severe respiratory impairment (GOLD stage III/IV; FEV1 <=50% predicted) 4. Incapacitating breathlessness (MRC dyspnoea score 4/5) 5. Able to provide written informed consent
Epistemonikos ID: 7ae98e61a48e86c3e90d11c4e5e06bdbafc2ca4a
First added on: Aug 22, 2024