Chronic Obstructive Pulmonary Disease Clinical Trial
— LENS-REHABOfficial title:
Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease : A Pilot Study
Verified date | January 2019 |
Source | ADIR Association |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 26, 2018 |
Est. primary completion date | October 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier du Havre | Le Havre |
Lead Sponsor | Collaborator |
---|---|
ADIR Association |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of endurance time (Tlim, in second) during constant workload testing (CWT) under 3 conditions. | 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. | 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. | |
Secondary | Dyspnea during CWT using modified Borg Scale (0-10). | 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). | 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 | |
Secondary | Exhaustion during CWT using modified Borg Scale (0-10). | 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). | 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.] | |
Secondary | Heart rate (rpm) during CWT. | 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). | 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 | |
Secondary | 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. | ||
Secondary | Oxygen saturation (SpO2, %) during CWT. | 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). | 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 | |
Secondary | O2 consumption (VO2, mL/kg/min) during CWT. | 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). | 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 | |
Secondary | Exercise ventilation (VE, L/min) during CWT. | 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). | 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 | |
Secondary | Tidal Volume (Vt, L) during CWT. | 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). | 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 | |
Secondary | Respiratory Rate (RR, rpm) during CWT. | 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). | 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 | |
Secondary | Variation of total hemoglobin (THb) using near infra red spectroscopy. | 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). | 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 | |
Secondary | Variation of total desoxy-hemoglobin (HHb) using near infra red spectroscopy. | 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). | 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 | |
Secondary | Variation of total oxy-hemoglobin (HbO2) using near infra red spectroscopy. | 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). | 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 | |
Secondary | 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 |
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