Chronic Obstructive Pulmonary Disease (COPD)NCT01658046
Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable Chronic Obstructive Pulmonary Disease (COPD)
A study testing Neuromuscular electrical stimulation, Endurance training and Quadriceps strength training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hacettepe University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Neuromuscular electrical stimulation, Endurance training and Quadriceps strength training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2009to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
Ankara, 06280
About this study
Official title: 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.
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.
- Being tested
- Neuromuscular electrical stimulation, Endurance training, Quadriceps strength training
- Keywords
- COPD, exercise, neuromuscular electrical stimulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationOther
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 trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NMES group | Experimental | 10 weeks neuromuscular electrical stimulation plus endurance training and quadriceps strength training. Receives: Other: Neuromuscular electrical stimulation; Other: Endurance training; Other: Quadriceps strength training |
| Control group | Sham comparator | 10 weeks sham neuromuscular electrical stimulation plus endurance training and quadriceps strength training. Receives: Other: Endurance training; Other: Quadriceps strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJul 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Responsible party
- Principal investigator, Deniz Inal-Ince, Hacettepe University
- Investigators
- Deniz Inal-Ince, PhD, PT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658046
- Sponsor's protocol ID
- NMES-COPD
- Other IDs
- Hacettepe University
- Status last verified
- Aug 2012
- First submitted
- 31 Jul 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable COPD
- ClinicalTrials.gov ID
- NCT01658046
- Acronym / sponsor ID
- NMES-COPD
- Keywords
- COPD, exercise, neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Study start
- Jul 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES group | Experimental | Other: Neuromuscular electrical stimulation, Other: Endurance training, Other: Quadriceps strength training10 weeks neuromuscular electrical stimulation plus endurance training and quadriceps strength training. |
| Control group | Sham comparator | Other: Endurance training, Other: Quadriceps strength training10 weeks sham neuromuscular electrical stimulation plus endurance training and quadriceps strength training. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationBilateral 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 | NMES group |
| Endurance trainingEndurance 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 | Control group, NMES group |
| Quadriceps strength trainingQuadriceps 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. | Other | Control group, NMES group |
Primary outcome
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.
1 secondary outcome
Endurance shuttle walk test
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Derived from this study: PubMed 26175226Tasdemir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Inal-Ince, PhD, PT principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation, Endurance training and Quadriceps strength training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental shuttle walk test (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01658046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.