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Completed

NCT Number: NCT02171377

Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients.

Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD) patients has been demonstrated to improve both dyspnea and physical status. The aim of our study is to demonstrate that ES added to respiratory rehabilitation program induces a greater improvement on exercise tolerance in such patients.

Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks), health education, global muscular strengthening. In group 2, bilateral quadricipital electrical stimulation 30 min sessions is added 5 days / week.

Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in stable conditions, and 18 > BMI < 35 kg/m² .

Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work rate, ventilatory threshold), physical activity with activity monitor, health related quality of life will be determined before and after training.

Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total lung capacity; BMI = body mass index.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in stable conditions, and 18 > BMI < 35 kg/m²

Exclusion criteria

  • BMI 18 < or > 35 kg/m²
  • Pregnant women
  • peripheral neuropathy
  • cardio respiratory incremental test contra-indication
  • evolutive cancer
  • cardiac or cerebral pace maker, implanted cardio defibrillator
  • no informed consent given

Treatment and study plan

group 2 : quadricipital electrical stimulation

Device

bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)

Pulmonary Rehabilitation

Other

exercise training, 3 to 5 times per week, 8 weeks

muscular electrical stimulation

Device

Bilateral quadricipital electrical stimulation 30 min, 5 times per week, 8 weeks,in addition to pulmonary rehabilitation

Other names: Mi-Theta-Pro device (Compex medical SA ; CH - 1024 Ecublens); reference 498000 ; serial number WB100000.

Primary outcomes

  1. 6 minute walking distance

    Time frame: From 6 to 8 weeks

Secondary outcomes

  1. incremental cardio pulmonary exercise test

    Time frame: From 6 to 8 weeks

    Aerobic capacity, maximal achieved work rate, ventilatory threshold

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: Reha-Res

Important dates

Study start
2010
Primary completion
2010
Study completion
2013
First posted
Jun 24, 2014
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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