Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658046
• Other study ID #: NMES-COPD
• Secondary ID: Hacettepe Univer
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: August 3, 2012
• Start date: July 2009
• Est. completion date: August 2011

Study information

• Verified date: August 2012
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Neuromuscular electrical stimulation
Bilateral quadriceps NMES using a four-channel portable electrical stimulator. Biphasic symmetric constant current impulses with a pulse width 300 µs, a frequency of 50 Hz, and duty cycle of 10 s on and 20 s off was applied for 20 min per day, 2 days per week for 10 weeks.
• Endurance training
Endurance training consists of 30 minutes of aerobic exercise (15 minutes on treadmill and 15 minutes on stationary bicycle) at 80% of maximal heart rate
• Quadriceps strength training
Quadriceps resistance training was applied using free weights for 2 days per week for 10 weeks according to 1 repetition maximum, starting at 45% for two sets.

Locations

Country	Name	City	State
Turkey	Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental shuttle walk test	The incremental shuttle walk test was performed in an enclosed corridor. Patients were required to walk back and forth, turning around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients followed the rhythm dictated by the audio signal.	10 weeks	No
Secondary	Endurance shuttle walk test	An endurance shuttle walk test was used to measure endurance walking capacity. The endurance shuttle walk test was performed 85% of peak oxygen consumption as predicted from the incremental shuttle walk test.	10 weeks	No