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

A randomised placebo-controlled trial investigating the effect of bilateral quadriceps NeuroMuscular Electrical Stimulation (NMES) on exercise capacity in patients with severe chronic obstructive pulmonary disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15985261

Enrollment

Registered

2012-05-31

Start date

2012-05-17

Completion date

Unknown

Last updated

2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease Respiratory Other chronic obstructive pulmonary disease

Interventions

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 activ

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Cardiac pacemaker 2. Co-existing neurological condition 3. Change in medication or exacerbation requiring admission in preceding 4 weeks 4. Recent systemic corticosteroids (>=5 consecutive days in last 4 weeks) 5. Current regular exerciser (structured training >=3 times/week within last month) 6. Adults unable to consent for themselves

Design outcomes

Primary

Measure	Time frame
Six-minute walk test (6MWT) at baseline, 6 and 12 weeks	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026