COPDNCT01799330
Rehabilitation of Patients With COPD Using Electrical Muscle Stimulation
A study testing Transcutaneous Electrical Muscle Stimulation (TCEMS) in people with COPD, run by Yale University at 1 site in United States.
Trial summary
The two hypotheses to be tested in this study are that: 1. The administration of transcutaneous electrical muscle stimulation (TCEMS) after completion of conventional exercise training in pulmonary rehabilitation (PR) will result in further improvements in exercise tolerance, functional status and symptoms of patients… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Transcutaneous Electrical Muscle Stimulation (TCEMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to 8 May 2014
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pulmonary function test criteria consistent with a diagnosis of COPD including forced expiratory volume in one second (FEV1) < 65% of predicted, with FEV1/FVC (forced vital capacity) ratio < 70%, lung hyperinflation based on a residual volume to total lung capacity (RV/TLC) ratio > 120% predicted and reduced diffusing capacity for carbon monoxide (DLCO <70% predicted).
- Self-reported exercise limitation despite pharmacologic treatment.
- Otherwise medically stable.
- Women and minorities will also be recruited. Only persons able to give fully informed consent will be enrolled in the study.
Who cannot join
- Patients will be excluded from study participation if they have a history of uncontrolled cardiovascular disease (including ventricular arrhythmia, myocardial infarction within 1 year, unstable angina, cardiac pacemaker or other implanted electrical device, other uncontrolled arrhythmias, or unstable blood pressure), neuromuscular disease (including stroke), debilitating joint disease or amputations that precludes exercise or have other contraindications to participating in outpatient PR (including unstable bone fracture, syncope of unclear etiology or cancer undergoing active chemotherapy), or are pregnant. Persons with a history of seizure disorder, intracranial clips or skin problems that would prevent safe or proper placement of the electrodes needed for electrical stimulation of the leg muscles will be excluded, based on prior clinical studies of TCEMS in non-COPD populations. Patients will also be excluded from study participation if they have undergone formal PR within 1 year of the date of study inclusion. No patients will be recruited from a "vulnerable patient population", including economically or educationally disadvantaged or mentally disabled persons, children, or prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
The two hypotheses to be tested in this study are that:
- The administration of transcutaneous electrical muscle stimulation (TCEMS) after completion of conventional exercise training in pulmonary rehabilitation (PR) will result in further improvements in exercise tolerance, functional status and symptoms of patients with stable chronic obstructive pulmonary disease (COPD) above those achieved in PR alone.
- TCEMS can improve exercise tolerance, functional status and symptoms even among COPD patients who fail to make gains in exercise tolerance by participating in conventional PR due to their debilitation and/or marked cardio-respiratory impairment.
Read the detailed description
Although a substantial body of evidence supports the existence of skeletal muscle dysfunction in COPD and the benefits of PR for these patients, the role of TCEMS as a routine rehabilitative strategy for patients with COPD has yet to be established. The studies proposed in this research will build on the knowledge gained in our previous study of TCEMS by investigating whether and how TCEMS adds to the beneficial effects of PR on exercise capacity and muscle function among outpatients with stable COPD, and by assessing for the first time whether TCEMS improves exercise tolerance and functional status among COPD patients unable to make gains following conventional outpatient PR. Thus, this proposed study may provide a novel strategy in the rehabilitation of patients with chronic lung disease.
The two specific aims of the proposed study are:
- Determine whether administration of TCEMS after conventional exercise training in PR leads to added gains in muscle strength, exercise capacity, dyspnea and health status, to determine if TCEMS should be considered as an additional routine method in outpatient PR programs.
- Determine whether patients who are unable to improve exercise tolerance during conventional exercise training in PR can achieve gains in muscle strength, exercise tolerance, dyspnea, and health status following TCEMS used as an alternate rehabilitative strategy.
- Conditions
- COPD
- Being tested
- Transcutaneous Electrical Muscle Stimulation (TCEMS), Sham TCEMS
- Keywords
- COPD, Rehabilitation, Exercise, TCEMS
- 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.
Transcutaneous Electrical Muscle Stimulation (TCEMS)Procedure or surgery
Sham TCEMSOther
Patients randomized to Group 2 (Sham TCEMS) will receive the identical set-up for active TCEMS except they will receive a minimal electrical stimulus that does not produce a motor response
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Active TCEMS | Experimental | Transcutaneous Electrical Muscle Stimulation (TCEMS): Group 1 will undergo TCEMS using an Omnistim FX-2 with two surface patch electrodes (8 x 6 cm) applied to each quadriceps, hamstring and calf muscles. The knee angle will remain at 90 degrees during simultaneous muscle stimulation to prevent joint movement. Electrical stimulation will be performed for 20 minutes on each limb, 3 days/week for 8 continuous weeks on an outpatient basis. The stimulator will be set to generate brief bursts of electrical impulses at 50Hz lasting 200 ms every 1500 ms. Muscles will be stimulated with an asymmetrical square wave pulse with an initial intensity set to create a visible contraction ranging from 55 mA to 120 mA. Receives: Procedure: Transcutaneous Electrical Muscle Stimulation (TCEMS) |
| Group 2: Sham TCEMS | Placebo comparator | Patients randomized to Group 2 (Sham TCEMS) will receive the identical set-up for active TCEMS except they will receive a minimal electrical stimulus that does not produce a motor response. Receives: Other: Sham TCEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Shuttle Walk Test (SWT)
The incremental Shuttle Walk Test will be used as a measure of exercise capacity. This test measures the maximal distance walked by the patient around two position markers set 10 meters apart, at a pace set by audio signals from a cassette tape. Minute-by-minute walking speed is increased until the patient feels too tired or short of breath to continue, or is unable to walk at least half of the 10 meter distance by the time the next audio signal is heard. Patients who routinely use supplemental oxygen will perform the test while carrying their portable oxygen delivery system during testing. As noted above, a practice run will be performed on the day the patient comes in for familiarization with the protocol and equipment. The investigator conducting the Shuttle Walk Test will be blinded to the groupings of subjects to avoid potential bias of the results.
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Secondary outcomes (9)
Body Composition
Body composition will be assessed using bioelectrical impedance analysis (Hydra 4200; Xitron Technologies, San Diego, CA) at a standardized time after breakfast. Bioelectrical impedance analysis (BIA) is a simple, safe, non-invasive method to measure assess lean (e.g., muscle) vs. fat body compartments. Fat-free mass will be calculated by using disease-specific equations as described by Schols. Fat mass will then be calculated as total body weight minus fat-free mass. Such BIA measurements are accurate, comparable to other techniques used to assess body composition, and have been validated in patients with COPD.
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Body Mass Index (BMI)
BMI is calculated as weight in kg/height in m2.
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Pulmonary Function
Spirometry, lung volume and diffusing capacity measurements will be performed according to standard procedure in the pulmonary function laboratory by a trained pulmonary function technician at either the Newington or West Haven Campus of VACHS according to American Thoracic Society Guidelines.
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Muscle Strength
Quadriceps and hamstring muscle maximal isokinetic strengths will be measured with the patient in an upright seated position, at an angular velocity of 60 degree/sec using a Biodex Multijoint System 2 dynamometer. Five duplicate leg extension and flexion measurements from a resting knee joint angle of 90 degrees will be made with adequate rest periods (2 min) in between efforts. The best peak torque value in Newton-meter (Nm) unit will be recorded.
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Six Minute Walk Test (6MWT) and Borg Dyspnea Rating
The total distance walked in 6 minutes is recorded. The 6 minute walk test is well validated for use and is used widely in pulmonary rehabilitation programs, as it is sensitive to changes in exercise endurance that occur following exercise training. The degree of perceived exertion will be assessed at the end of the 6MWT using a Borg Dyspnea scale (a patient-reported numerical rating of the degree of dyspnea associated with any given degree of exertion).
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Cardiopulmonary Exercise Test
Maximal symptom-limited incremental cardiopulmonary exercise testing (CPET) will be performed by a pulmonary function/exercise technologist according to standard methods used in the West Haven VA Pulmonary Function Laboratory, using a calibrated cycle ergometer (Collins Gold Standard Plus Cardiopulmonary Exercise System, Pulmonary Data Services, Louisville, CO) with a pedaling frequency of 40 revolutions per minute, during which the workload will increase by 5-20 Watt increments every minute depending on the subjects' exercise capacity. Breathing rate, tidal volume, minute ventilation, and electrocardiography will be measured continuously according to standard procedure. Oxygen consumption and carbon dioxide production will be calculated from the fractional concentrations of oxygen and carbon dioxide in the mixed expired gas using a Collins CPX Unit metabolic system (Pulmonary Data Services, Louisville, CO).
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Dyspnea Scale
The Medical Research Council Dyspnea Scale is a simple questionnaire in which the patient rates the level of exertion/activity at which he/she experiences dyspnea, by checking one of five boxes on a five point scale. This questionnaire takes approximately 5 minutes to complete.
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Chronic Respiratory Disease Questionnaire
The Chronic Respiratory Disease Questionnaire is a respiratory-specific health status instrument in which patients give responses to simple questions encompassing four principal domains: dyspnea, fatigue, emotion and mastery. This questionnaire is used routinely worldwide as a health status outcomes measure in pulmonary rehabilitation programs, including the outpatient PR program at the West Haven VA, as it is highly responsive to the PR intervention. Total and the four sub-scores for each of the domains tested will be analyzed.
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Medical Outcome Survey Short-Form-36 (SF-36) Questionnaire
The SF-36 is a general health status questionnaire in which patients give responses to questions encompassing domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and mental summary scores can be calculated from these subscales.
Measured: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startDec 2008
- Primary completion8 May 2014
- Study completion8 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Yale 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Responsible party
- Sponsor
- Investigators
- Carolyn L Rochester, MD, Principal investigator, VA Connecticut Healthcare System/ Yale University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799330
- Sponsor's protocol ID
- 0809004250
- Status last verified
- Sep 2020
- First submitted
- 22 Feb 2013
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Patients With COPD Using Electrical Muscle Stimulation
- ClinicalTrials.gov ID
- NCT01799330
- Acronym / sponsor ID
- 0809004250
- Conditions
- COPD
- Keywords
- COPD, Rehabilitation, Exercise, TCEMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Study start
- Dec 2008 (actual)
- Primary completion
- 8 May 2014 (actual)
- Study completion
- 8 May 2014 (actual)
- First posted
- 26 Feb 2013 (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.
The two hypotheses to be tested in this study are that:
- The administration of transcutaneous electrical muscle stimulation (TCEMS) after completion of conventional exercise training in pulmonary rehabilitation (PR) will result in further improvements in exercise tolerance, functional status and symptoms of patients with stable chronic obstructive pulmonary disease (COPD) above those achieved in PR alone.
- TCEMS can improve exercise tolerance, functional status and symptoms even among COPD patients who fail to make gains in exercise tolerance by participating in conventional PR due to their debilitation and/or marked cardio-respiratory impairment.
Detailed description
Although a substantial body of evidence supports the existence of skeletal muscle dysfunction in COPD and the benefits of PR for these patients, the role of TCEMS as a routine rehabilitative strategy for patients with COPD has yet to be established. The studies proposed in this research will build on the knowledge gained in our previous study of TCEMS by investigating whether and how TCEMS adds to the beneficial effects of PR on exercise capacity and muscle function among outpatients with stable COPD, and by assessing for the first time whether TCEMS improves exercise tolerance and functional status among COPD patients unable to make gains following conventional outpatient PR. Thus, this proposed study may provide a novel strategy in the rehabilitation of patients with chronic lung disease.
The two specific aims of the proposed study are:
- Determine whether administration of TCEMS after conventional exercise training in PR leads to added gains in muscle strength, exercise capacity, dyspnea and health status, to determine if TCEMS should be considered as an additional routine method in outpatient PR programs.
- Determine whether patients who are unable to improve exercise tolerance during conventional exercise training in PR can achieve gains in muscle strength, exercise tolerance, dyspnea, and health status following TCEMS used as an alternate rehabilitative strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:Active TCEMS | Experimental | Procedure: Transcutaneous Electrical Muscle Stimulation (TCEMS)Transcutaneous Electrical Muscle Stimulation (TCEMS): Group 1 will undergo TCEMS using an Omnistim FX-2 with two surface patch electrodes (8 x 6 cm) applied to each quadriceps, hamstring and calf muscles. The knee angle will remain at 90 degrees during simultaneous muscle stimulation to prevent joint movement. Electrical stimulation will be performed for 20 minutes on each limb, 3 days/week for 8 continuous weeks on an outpatient basis. The stimulator will be set to generate brief bursts of electrical impulses at 50Hz lasting 200 ms every 1500 ms. Muscles will be stimulated with an asymmetrical square wave pulse with an initial intensity set to create a visible contraction ranging from 55 mA to 120 mA. |
| Group 2: Sham TCEMS | Placebo comparator | Other: Sham TCEMSPatients randomized to Group 2 (Sham TCEMS) will receive the identical set-up for active TCEMS except they will receive a minimal electrical stimulus that does not produce a motor response. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pulmonary function test criteria consistent with a diagnosis of COPD including forced expiratory volume in one second (FEV1) < 65% of predicted, with FEV1/FVC (forced vital capacity) ratio < 70%, lung hyperinflation based on a residual volume to total lung capacity (RV/TLC) ratio > 120% predicted and reduced diffusing capacity for carbon monoxide (DLCO <70% predicted).
- Self-reported exercise limitation despite pharmacologic treatment.
- Otherwise medically stable.
- Women and minorities will also be recruited. Only persons able to give fully informed consent will be enrolled in the study.
Key exclusion criteria (1 listed)
- Patients will be excluded from study participation if they have a history of uncontrolled cardiovascular disease (including ventricular arrhythmia, myocardial infarction within 1 year, unstable angina, cardiac pacemaker or other implanted electrical device, other uncontrolled arrhythmias, or unstable blood pressure), neuromuscular disease (including stroke), debilitating joint disease or amputations that precludes exercise or have other contraindications to participating in outpatient PR (including unstable bone fracture, syncope of unclear etiology or cancer undergoing active chemotherapy), or are pregnant. Persons with a history of seizure disorder, intracranial clips or skin problems that would prevent safe or proper placement of the electrodes needed for electrical stimulation of the leg muscles will be excluded, based on prior clinical studies of TCEMS in non-COPD populations. Patients will also be excluded from study participation if they have undergone formal PR within 1 year of the date of study inclusion. No patients will be recruited from a "vulnerable patient population", including economically or educationally disadvantaged or mentally disabled persons, children, or prisoners.
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 |
|---|---|---|
| Transcutaneous Electrical Muscle Stimulation (TCEMS) | Procedure or surgery | Group 1:Active TCEMS |
| Sham TCEMSPatients randomized to Group 2 (Sham TCEMS) will receive the identical set-up for active TCEMS except they will receive a minimal electrical stimulus that does not produce a motor response | Other | Group 2: Sham TCEMS |
Primary outcome
Incremental Shuttle Walk Test (SWT)
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
The incremental Shuttle Walk Test will be used as a measure of exercise capacity. This test measures the maximal distance walked by the patient around two position markers set 10 meters apart, at a pace set by audio signals from a cassette tape. Minute-by-minute walking speed is increased until the patient feels too tired or short of breath to continue, or is unable to walk at least half of the 10 meter distance by the time the next audio signal is heard. Patients who routinely use supplemental oxygen will perform the test while carrying their portable oxygen delivery system during testing. As noted above, a practice run will be performed on the day the patient comes in for familiarization with the protocol and equipment. The investigator conducting the Shuttle Walk Test will be blinded to the groupings of subjects to avoid potential bias of the results.
9 secondary outcomes
Body Composition
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Body Mass Index (BMI)
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Pulmonary Function
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Muscle Strength
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Six Minute Walk Test (6MWT) and Borg Dyspnea Rating
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Cardiopulmonary Exercise Test
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Dyspnea Scale
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Chronic Respiratory Disease Questionnaire
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
Medical Outcome Survey Short-Form-36 (SF-36) Questionnaire
Time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS
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 28 Sep 2020.
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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.
Carolyn L Rochester, MD principal investigator
VA Connecticut Healthcare System/ Yale University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Muscle Stimulation (TCEMS) in people with COPD, run by Yale University at 1 site in United States.
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 1 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 28 Sep 2020. 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 United States. 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 (SWT) (time frame: Baseline, Post 8 Weeks PR, Post 8 Weeks Active/Sham TCEMS). 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 28 Sep 2020.