Chronic Obstructive Pulmonary DiseasePhase 3NCT00677690
Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing neuromuscular electrical stimulation (NMES) in people with Chronic Obstructive Pulmonary Disease, run by Fondazione Salvatore Maugeri at 1 site in Italy.
Trial summary
The purpose of this study is to elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- neuromuscular electrical stimulation (NMES)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD
- Must be able to walk
Who cannot join
- Previous or current diagnosis of chronic respiratory failure
- A history of diseases other than COPD, in particular neurological disease
- Need for treatment with systemic steroids during the rehabilitation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
The purpose of this study is to elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (COPD).
Read the detailed description
Neuromuscular electrical stimulation (NMES) has been extensively used as technique to improve muscle function in different areas of rehabilitation, however it seems to be more appropriate in critical care situation, while its use in more able patients is of uncertain benefit. In other words, NMES seems to be particularly effective in severely deconditioned and bed ridden patients. We therefore carried out a randomised trial to compare the efficacy of combination of NMES and PR (NM+PR) with combination of sham stimulation and PR (SS+PR) in a large population of moderately impaired COPD patients. Primary outcome was evaluation of effect of NMES on quadriceps strength and on exercise capacity. Secondary outcome was evaluation of effect of NMES on symptoms (dyspnoea) and quality of life.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- neuromuscular electrical stimulation (NMES), Sham electrical stimulation
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulation (NMES)Other
Also called pulmonary rehabilitation
NMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks.
Sham electrical stimulationOther
Also called pulmonary rehabilitation
Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.
| Study group | Role | What they receive |
|---|---|---|
| NM+PR | Active comparator | Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR) Receives: Other: neuromuscular electrical stimulation (NMES) |
| SS+PR | Placebo comparator | Patients undergone to pulmonary rehabilitation Receives: Other: Sham electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
6 minute walk test(6MWT)
Measured: 5 weeks
Quadriceps Strength
Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.
Measured: 5 weeks
Secondary outcomes (3)
Dyspnoea
The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.
Measured: 5 weeks
Quality of Life
St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).
Measured: 5 weeks
Respiratory Function
forced expiratory volume in 1 second (FEV1)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercole Zanotti, Fondazione Salvatore Maugeri
- Investigators
- ercole zanotti, MD, Principal investigator, Fondazione Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677690
- Sponsor's protocol ID
- 05/2008
- Status last verified
- Nov 2011
- First submitted
- 8 May 2008
- Last updated
- 16 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
- ClinicalTrials.gov ID
- NCT00677690
- Acronym / sponsor ID
- 05/2008
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Posted 20 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (COPD).
Detailed description
Neuromuscular electrical stimulation (NMES) has been extensively used as technique to improve muscle function in different areas of rehabilitation, however it seems to be more appropriate in critical care situation, while its use in more able patients is of uncertain benefit. In other words, NMES seems to be particularly effective in severely deconditioned and bed ridden patients. We therefore carried out a randomised trial to compare the efficacy of combination of NMES and PR (NM+PR) with combination of sham stimulation and PR (SS+PR) in a large population of moderately impaired COPD patients. Primary outcome was evaluation of effect of NMES on quadriceps strength and on exercise capacity. Secondary outcome was evaluation of effect of NMES on symptoms (dyspnoea) and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NM+PR | Active comparator | Other: neuromuscular electrical stimulation (NMES)Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR) |
| SS+PR | Placebo comparator | Other: Sham electrical stimulationPatients undergone to pulmonary rehabilitation |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of COPD
- Must be able to walk
Key exclusion criteria (3 listed)
- Previous or current diagnosis of chronic respiratory failure
- A history of diseases other than COPD, in particular neurological disease
- Need for treatment with systemic steroids during the rehabilitation period
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 stimulation (NMES)Also: pulmonary rehabilitationNMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks. | Other | NM+PR |
| Sham electrical stimulationAlso: pulmonary rehabilitationSham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz. | Other | SS+PR |
Primary outcome
Exercise Capacity
Time frame: 5 weeks
6 minute walk test(6MWT)
Quadriceps Strength
Time frame: 5 weeks
Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.
3 secondary outcomes
Dyspnoea
Time frame: 5 weeks
Quality of Life
Time frame: 5 weeks
Respiratory Function
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
COPD - Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Recruiting
Study on Impact of Maximal Strength Training in Patients With COPD
Chronic Obstructive Pulmonary Disease
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.
ercole zanotti, MD principal investigator
Fondazione Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neuromuscular electrical stimulation (NMES) in people with Chronic Obstructive Pulmonary Disease, run by Fondazione Salvatore Maugeri at 1 site in Italy.
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 2 inclusion and 3 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 16 Nov 2011. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Exercise Capacity (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2011.