Clinical trial NCT01658046: Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
exercise
neuromuscular electrical stimulation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
First posted: 2012-08-06
Enrollment: 27
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.

Detailed description: Skeletal muscle dysfunction is common and impaires exercise capacity in patients with chronic obstructive pulmonary disease (COPD)Exercise training is the main component of the treatment of COPD.

Neuromuscular electrical stimulation (NMES) is successful in COPD patients who are unable to perform exercise training. The NMES has positive effect on peripheral muscle function, exercise capacity and breathlessness in activities of daily living in COPD patients who had an abnormal body composition or who were too dyspneic to leave their home. A nonrandomized uncontrolled study has shown that application of NMES at home for improved exercise capacity in patients with better-preserved muscle mass. Evidence from a preliminary study without applying sham NMES revealed that NMES applied as complementary to ambulatory respiratory rehabilitation program increased quadriceps strength, quality of life and six minute walk distance in severe to very severe patients.

Despite documented benefits of NMES in COPD patients, the place of NMES as an adjunct to pulmonary rehabilitation in COPD patients who were able to do regular endurance and strength training on is unknown. Therefore, the purpose of this study was to compare the effects of NMES plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, dyspnea, fatigue, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.

Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic obstructive pulmonary disease
* being 35-75 years of age
* being eligible to participate in endurance trainin
* no acute exacerbation in last month, no change in drugs and no usage of antibiotics in last three weeks

Exclusion Criteria:

* medical conditions which could place patient at risk during neuromuscular electrical stimulation and exercise training (orthophedic and neuromuscular disorders, metal implants in the lower limbs, advanced heart failure, aortic stenosis, deep venous thrombosis a cardiac pacemaker, \>50 mmHg pulmonary artery pressure and/or an acute exacerbation of symtomps in the preceeding four weeks)
* being unable to understand the questionnaires and unable to cooparate.

Primary outcomes:
measure: Incremental shuttle walk test
timeFrame: 10 weeks
Secondary outcomes:
measure: Endurance shuttle walk test
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
Study officials:
affiliation: Hacettepe University
name: Deniz Inal-Ince, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tasdemir F, Inal-Ince D, Ergun P, Kaymaz D, Demir N, Demirci E, Egesel N. Neuromuscular electrical stimulation as an adjunct to endurance and resistance training during pulmonary rehabilitation in stable chronic obstructive pulmonary disease. Expert Rev Respir Med. 2015 Aug;9(4):493-502. doi: 10.1586/17476348.2015.1068691. Epub 2015 Jul 15.