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An investigation into the effect of neuromuscular electrical stimulation (NMES) and pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46428072
Enrollment
40
Registered
2007-09-28
Start date
2006-08-26
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease

Interventions

The study design will be a single blind randomised controlled study in which the patients will be randomised to one of two groups: 1. Pulmonary rehabilitation plus NMES 2. Pulmonary rehabilitation plu

Sponsors

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of COPD 2. Declining functional capacity (Medical Research Council [MRC] grade 3 and above) 3. On optimal pharmacological treatment 4. Clinical stable (no exacerbation within 4 weeks of initial assessment and not taking antibiotics/oral steroids for an acute infection) 5. Smokers will be included 6. Patients receiving long-term oxygen therapy (LTOT) will be included 7. Evidence of nutritional depletion - body weight less than 90% of ideal body weight (IBW) and/or fat-free mass (FFM) less than 69% IBW (males) and 67% IBW (females) 8. Evidence of peripheral muscle weakness (quadriceps force less than 80% predicted and/or hand grip strength less than 80% predicted)

Exclusion criteria

Exclusion criteria: 1. Unstable heart disease (and patients with pacemakers) 2. Untreated hypertension 3. Untreated hypothyroidism 4. Angina 5. Pregnancy 6. Arthritis (such that patient is unable to perform an exercise test and take part in an exercise training programme) or other mobility problems that will limit exercise capacity 7. Patients unable (or unwilling) to attend the hospital three times weekly for exercise training sessions 8. Patients unwilling to commit to lifestyle changes 9. Patients having an acute exacerbation of their disease within the previous 4 weeks

Design outcomes

Primary

MeasureTime frame
Improvement in exercise tolerance assessed by the Incremental Shuttle Walking Test. This will be assessed by comparing the magnitude of the improvement in walking distance between patients randomised to receive pulmonary rehabilitation alone and those receiving pulmonary rehabilitation plus NMES.

Secondary

MeasureTime frame
1. Changes in peak oxygen uptake 2. Changes in endurance exercise performance 3. Changes in health status 4. Changes in muscle function 5. Changes in calf muscle blood flow capacity All these will be assessed in terms of firstly, whether there has been an overall improvement in the function in each group and secondly, whether there is a statistically significant difference in the magnitude of the improvement between patients receiving pulmonary rehabilitation alone and those receiving pulmonary rehabilitation plus NMES.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026