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

August 3, 2012 updated by: Deniz Inal-Ince, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06280
        • Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMES group
10 weeks neuromuscular electrical stimulation plus endurance training and quadriceps strength training.
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.
Other: 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
Other: 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.
Sham Comparator: Control group
10 weeks sham neuromuscular electrical stimulation plus endurance training and quadriceps strength training.
Other: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental shuttle walk test
Time Frame: 10 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance shuttle walk test
Time Frame: 10 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Investigators

  • Principal Investigator: Deniz Inal-Ince, PhD, PT, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 6, 2012

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMES-COPD
  • Hacettepe University (Other Identifier: Hacettepe University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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