Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease (LENS-REHAB)

ADIR Association

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: High-frequency transcutaneous electrical nerve stimulation; Other: Low-frequency transcutaneous electrical nerve stimulation; Other: Sham transcutaneous electrical nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03312322

LENS-REHAB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years;
• Chronic obstructive pulmonary disease Gold III-IV;
• Eligible for pulmonary rehabilitation;
• Never used electrical stimulation.

Non-inclusion Criteria:

• Pregnant woman or likely to be;
• Patient under guardianship;
• History of epilepsy, heart pace-maker or defibrillator, inguinal or abdominal hernia;
• Recent lumbar surgery or skin lesion;
• Allergy to surface electrodes;
• Lumbar sensitivity impairment;
• Opiate treatment during the last 3 months.

Exclusion criteria

• Acute exacerbation of chronic obstructive pulmonary disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 3 patient groups

CWT with high-frequency electrical nerve stimulation

Experimental group

Description:

This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.

Treatment:

Other: High-frequency transcutaneous electrical nerve stimulation

CWT with low-frequency electrical nerve stimulation

Experimental group

Description:

This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.

Treatment:

Other: Low-frequency transcutaneous electrical nerve stimulation

CWT with sham electrical nerve stimulation

Experimental group

Description:

This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.

Treatment:

Other: Sham transcutaneous electrical nerve stimulation