NCT03312322

Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease

Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease : A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: ADIR Association · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic obstructive pulmonary disease is a leading cause of morbidity and mortality worldwide. Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory disease. There is a link between training intensity and physiological improvements following pulmonary rehabilitation. However, high intensity training is not sustainable for every patients. Therefore, actual strategies for pulmonary rehabilitation aimed at decreasing dyspnea to improve muscle work. Electrical muscle stimulation is widely used during rehabilitation to promote muscle function recovery. Transcutaneous electrical nerve stimulation was recently used to relief dyspnea and improve pulmonary function in patients with chronic respiratory disease. Moreover, spinal anesthesia with fentanyl has been shown to be effective in improving exercise tolerance in patients with chronic obstructive pulmonary disease (inhibiting group III and IV muscle afferents). As transcutaneous electrical muscle stimulation stimulates the same receptors in the spinal cord dorsal horn as fentanyl, it is hypothesized that it could also improve exercise capacity. Therefore, the aim of this study is to assess wether transcutaneous electrical stimulation (high or low frequency) is effective in improving exercise capacity in patients with severe to very severe chronic obstructive pulmonary disease.

Detailed description

Design : cross-over. Patients will perform three constant workload testing (CWT) on different days under three different conditions. The intervention during the tests will be randomly assigned (concealed allocation) : * Sham transcutaneous electrical nerve stimulation ; * High-frequency transcutaneous electrical nerve stimulation ; * Low-frequency transcutaneous electrical nerve stimulation.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	High-frequency transcutaneous electrical nerve stimulation	4 self adhesive surface electrodes are positioned by pair at the L3-L4 level, laterally. Stimulation is setted at rest, 10min before constant workload testing. During this period, intensity is increased every 3minutes to the maximum tolerated by the patient (pain threshold). Thereafter, intensity is not increased anymore during the test. It is explained to the patient that he might or no experience the electrical stimulation sensation. Current characteristics : 100Hertz, 100ms, bidirectional. Constant workload testing : 60-70rpm ; 75% Wpic ; up to exhaustion or rpm \< 60 during more than 10s.
OTHER	Low-frequency transcutaneous electrical nerve stimulation	4 self adhesive surface electrodes are positioned by pair at the L3-L4 level, laterally. Stimulation is setted at rest, 10min before constant workload testing. During this period, intensity is increased every 3minutes to the maximum tolerated by the patient (pain threshold). Thereafter, intensity is not increased anymore during the test. It is explained to the patient that he might or no experience the electrical stimulation sensation. Current characteristics : 4Hertz, 100ms, bidirectional. Constant workload testing : 60-70rpm ; 75% Wpic ; up to exhaustion or rpm \< 60 during more than 10s.
OTHER	Sham transcutaneous electrical nerve stimulation	The procedure is the same as high-frequency transcutaneous electrical stimulation but intensity is progressively setted back to 1mA (over a 45sec period) after every increment so that constant workload testing is performed with 1mA.

Timeline

• Start date: 2017-12-12
• Primary completion: 2018-10-26
• Completion: 2018-10-26
• First posted: 2017-10-17
• Last updated: 2019-01-09

Locations

1 site across 1 country: France