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CompletedNCT01658046Updated Aug 6, 2012

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

An interventional study of Neuromuscular electrical stimulation and Endurance training in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-08-06.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • COPD
  • exercise
  • neuromuscular electrical stimulation
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 27 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    NMES group

    10 weeks neuromuscular electrical stimulation plus endurance training and quadriceps strength training.

    Other: Neuromuscular electrical stimulation · Other: Endurance training · Other: Quadriceps strength training

  • Sham comparator
    Control group

    10 weeks sham neuromuscular electrical stimulation plus endurance training and quadriceps strength training.

    Other: Endurance training · Other: Quadriceps strength training

Interventions

  • OtherNeuromuscular 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.

  • OtherEndurance 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

  • OtherQuadriceps 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 weeks

Secondary outcomes

  1. 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.

    Time frame: 10 weeks

07

Study locations

1 site
  • Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
    Ankara, 06280, Turkey
08

References and documents

Publications

  • 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. PubMed 26175226 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01658046
Lead sponsor
Hacettepe University
Collaborators
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Responsible party
Deniz Inal-Ince (PhD, PT, Associated Professor, Hacettepe University) — Principal investigator
First posted
Aug 6, 2012
Start date
Jul 2009
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Aug 6, 2012

Study contacts

Deniz Inal-Ince, PhD, PT
principal investigator · Hacettepe University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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