Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

NCT02171377 | Completed DMC

• 2 other identifiers: 2009/091/HP2009-A00665-52
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; electrical stimulation; Rehabilitation; exercise test

Outcome Measures

Primary Outcomes (1)

• 6 minute walking distance

  From 6 to 8 weeks

Secondary Outcomes (1)

• incremental cardio pulmonary exercise test

  From 6 to 8 weeks

Study Arms (2)

Group 2 : quadricipital electrical stimulation

EXPERIMENTAL

stimulation in addition to rehabilitation (30 min bilateral quadricipital electrical stimulation pd, 5 days per week, 8 weeks)

Device: group 2 : quadricipital electrical stimulation; Device: muscular electrical stimulation

Group 1 : Pulmonary rehabilitation

ACTIVE COMPARATOR

Pulmonary rehabilitation 3 to 5 times per week, 8 weeks

Other: pulmonary rehabilitation

Interventions

group 2 : quadricipital electrical stimulation DEVICE

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

Group 2 : quadricipital electrical stimulation

pulmonary rehabilitation OTHER

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

Group 1 : Pulmonary rehabilitation

muscular electrical stimulation DEVICE

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

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

Group 2 : quadricipital electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (1)

• Bonnevie T, Gravier FE, Debeaumont D, Viacroze C, Muir JF, Cuvelier A, Netchitailo M, Roy AL, Quieffin J, Marques MH, Medrinal C, Dupuis J, Tardif C. Home-based Neuromuscular Electrical Stimulation as an Add-on to Pulmonary Rehabilitation Does Not Provide Further Benefits in Patients With Chronic Obstructive Pulmonary Disease: A Multicenter Randomized Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1462-1470. doi: 10.1016/j.apmr.2018.01.024. Epub 2018 Feb 16.

  PMID: 29457998 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: June 24, 2014
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2013
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

FR (1)