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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Endurance training
Quadriceps strength training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, exercise, neuromuscular electrical stimulation

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

NMES group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 31, 2012
Last Updated
August 3, 2012
Sponsor
Hacettepe University
Collaborators
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01658046
Brief Title
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, exercise, neuromuscular electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NMES group
Arm Type
Experimental
Arm Description
10 weeks neuromuscular electrical stimulation plus endurance training and quadriceps strength training.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
10 weeks sham neuromuscular electrical stimulation plus endurance training and quadriceps strength training.
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Endurance training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Quadriceps strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incremental shuttle walk test
Description
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 Outcome Measure Information:
Title
Endurance shuttle walk test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Inal-Ince, PhD, PT
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
City
Ankara
ZIP/Postal Code
06280
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
26175226
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.
Results Reference
derived

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

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