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

Not Applicable
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Other: Low-frequency transcutaneous electrical nerve stimulation
Other: Sham transcutaneous electrical nerve stimulation
Other: High-frequency transcutaneous electrical nerve stimulation
Registration Number
NCT03312322
Lead Sponsor
ADIR Association
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
CWT with low-frequency electrical nerve stimulationLow-frequency transcutaneous electrical nerve stimulationThis 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.
CWT with sham electrical nerve stimulationSham transcutaneous electrical nerve stimulationThis 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.
CWT with high-frequency electrical nerve stimulationHigh-frequency transcutaneous electrical nerve stimulationThis 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.
Primary Outcome Measures
NameTimeMethod
Comparison of endurance time (Tlim, in second) during constant workload testing (CWT) under 3 conditions.The outcome will be measured after every CWT. Data will be continuously collected during the tests. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.

Patients will achieve 3 constant workload testing under 3 different conditions (sham lumbar transcutaneous electrical nerve stimulation, high-frequency lumbar electrical nerve stimulation and low-frequency lumbar transcutaneous electrical nerve stimulation). Endurance time (sec) will be recorded at the end of every test. Endurance time will be compared to assess how the condition will influence exercice performance.

Secondary Outcome Measures
NameTimeMethod
Oxygen saturation (SpO2, %) during CWT.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Exhaustion during CWT using modified Borg Scale (0-10).The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.]

The exhaustion will be assessed every 30sec during CWT. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Variation of total hemoglobin (THb) using near infra red spectroscopy.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Intensity of electrical stimulation (mA) reached during every CWT.The outcome will be measured after every CWT. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected
Dyspnea during CWT using modified Borg Scale (0-10).The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests

The dyspnea will be assessed every 30sec during CWT. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Heart rate (rpm) during CWT.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Blood pressure (mmHg) before and after every CWT.The outcome will be assessed before and after every CWT. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum.
O2 consumption (VO2, mL/kg/min) during CWT.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Exercise ventilation (VE, L/min) during CWT.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Tidal Volume (Vt, L) during CWT.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Variation of total desoxy-hemoglobin (HHb) using near infra red spectroscopy.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Respiratory Rate (RR, rpm) during CWT.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Variation of total oxy-hemoglobin (HbO2) using near infra red spectroscopy.The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected

Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

Trial Locations

Locations (1)

Groupe Hospitalier du Havre

🇫🇷

Le Havre, France

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