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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
INTERVENTION: 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 plus sham NMES Patients will each be given an identical NMES device and therefore will not be aware which study group they are in. COPD patients will be recruited from those attending for the 8‐week pulmonary rehabilitation (PR) programme at the Lung Investigation Unit, Queen Elizabeth Hospital, University Hospital Trust, Birmingham. Following recruitment and consent patients will undergo a baseline evaluation prior to the exercise training programme that will be repeated at the end of the 8‐week training regime. The assessment pre‐ and post‐pulmonary rehabilitation will require patients to attend the hospital for three visits at each time point in order to complete the baseline and outcome measurements (N.B. patients already undergo two assessment visits at the start and end of the current pulmonary rehabilitation programme, thus participation in the research study will only require them to attend the laboratory for one extra visit at the start and end of the programme). Patients will also be assessed on these occasions as to whether they require additional educational support with regard to medication, inhaler technique, dietary advice and social support. Those measurements highlighted with an asterisk indicate those that are not part of the current protocol for patients undergoing assessment for pulmonary rehabilitation. Assessment Day 1: 1. Anthropometric measurements (weight, height) 2. Peak oxygen uptake 3. Endurance exercise capacity 4. Health status (36‐item short form health survey [SF36], Chronic Respiratory Disease Questionnaire [CRQ], MRC scale* and Hospital Anxiety and Depression [HAD]* questionnaires) 5. Habitual activity (patients will be issued with an activity monitor for use at home) Assessment Day 2: 1. Lung function 2. Body composition (skin fold thi CONDITION: Chronic obstructive pulmonary disease (COPD) ; Respiratory ; Other chronic obstructive pulmonary disease PRIMARY OUTCOME: 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 OUTCOME: 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. 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)
Epistemonikos ID: dea14268e193831fb8e32cb3e57bb88b276f99ec
First added on: Aug 21, 2024