Chronic Obstructive Pulmonary Disease (COPD)NCT06761963
Chronic Effect of Whole-body Electrical Stimulation in COPD Patients
A study testing Whole-body electrical stimulation and Rehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Federal University of Health Science of Porto Alegre.
Trial summary
Randomized clinical trial. Patients with chronic obstructive pulmonary disease (COPD) GOLD III or IV will undergo 16 sessions of Whole-body Electrical Stimulation (WB-EMS) or pulmonary rehabilitation (PR), twice a week. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Whole-body electrical stimulation and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD GOLD 3 and 4;
- Age between 18 and 80 years;
- Ability to ambulate.
Who cannot join
- Cognitive dysfunction that prevents assessments from being carried out, as well as inability to understand and sign the informed consent form (ICF);
- Intolerance to the electrostimulator and/or change in skin sensitivity;
- Patients with stroke sequelae;
- Recent acute myocardial infarction (two months);
- Uncontrolled hypertension;
- New York Heart Association grade IV heart failure or decompensated;
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- Unstable angina or arrhythmia;
- Peripheral vascular changes in lower limbs such as deep vein thrombosis;
- Disabling osteoarticular or musculoskeletal disease;
- Uncontrolled diabetes (glycemia > 300mg/dL);
- Patients with cancer and/or undergoing cancer treatment;
- Patients with systemic lupus erythematosus or other autoimmune disease;
- Artificial cardiac pacemaker;
- Epilepsy;
- Hemophilia;
- Liver and kidney diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Randomized clinical trial. Patients with chronic obstructive pulmonary disease (COPD) GOLD III or IV will undergo 16 sessions of Whole-body Electrical Stimulation (WB-EMS) or pulmonary rehabilitation (PR), twice a week. WB-EMS will be performed in association with squats, biceps and triceps exercises, climbing up and down a step, and abdominal exercises. There will be a progression in the number of muscle contractions after the fourth (from 64 to 96) and tenth sessions (96 to 120). PR will consist of upper and lower limb strengthening exercises. Both groups will perform aerobic exercise (essential component of the pulmonary rehabilitation program). Peripheral muscle strength (dynamometry), respiratory muscle strength (maximum inspiratory and expiratory pressure), muscle thickness (ultrasound), functional capacity (6MWT), quality of life (Saint George's Respiratory Questionnaire), inflammatory profile (PCR, IL-6 e IL-10, TNFα), oxidative stress (protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate) will be assessed before and after the 16 sessions.
Read the detailed description
Patients with chronic obstructive pulmonary disease (COPD) will undergo a 16-session whole-body electrical stimulation (WB-EMS) protocol or a pulmonary rehabilitation program, twice a week, for eight weeks. The Miha Bodytec equipment will be properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles. Symmetrical pulsed biphasic current will be used, pulse width of 400 µs, frequency of 75 Hz. In the first two weeks, the contraction time will be five seconds and the rest time will be 10 seconds, the session will last 16 minutes, resulting in 64 muscle contractions. In weeks 3, 4 and 5, the contraction time will be five seconds and the rest time will be five seconds, the session will last 16 minutes, resulting in 96 muscle contractions. In weeks 6, 7 and 8, the contraction time will be five seconds and the rest time will be five seconds. The session will last 20 minutes, resulting in 120 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometric position to familiarize themselves with the electrical current. After that, a series of squats, biceps and triceps exercises (using a proprioception stick), abdominal exercises and climbing up and down a step will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Pulmonary rehabilitation will consist of muscle strengthening exercises, using weights, ankle weights and weight training equipment. Squats, biceps and triceps exercises (with weights), knee flexion and extension (equipment with weights) and stretching will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Peripheral muscle strength (dynamometry), respiratory muscle strength (maximum inspiratory and expiratory pressure), muscle thickness (ultrasound), functional capacity (6MWT), quality of life (Saint George's Respiratory Questionnaire), inflammatory profile (PCR, IL-6 e IL-10, TNFα), oxidative stress (protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate) will be assessed before and after the 16 sessions.
- Being tested
- Whole-body electrical stimulation, Rehabilitation
- 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.
Whole-body electrical stimulationOther
Performed using Miha Bodytec equipment, properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles.
RehabilitationOther
Pulmonary rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| whole-body electrical stimulation | Experimental | Performed with calibrated Miha Bodytec equipment, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi, and quadratus lumborum. A symmetrical biphasic current, 400µs pulse width, 75Hz frequency will be used. Sixteen sessions will occur twice weekly for eight weeks. In weeks 1-2, contractions last five seconds with 10 seconds rest, for 16 minutes (64 contractions). In weeks 3-5, contractions remain five seconds with five seconds rest, also lasting 16 minutes (96 contractions). In weeks 6-8, contractions/rest stay at five seconds each, lasting 20 minutes (120 contractions). Initial isometric positions familiarize the patient with stimulation, followed by squats, biceps/triceps exercises with a proprioception stick, abdominal exercises, step-up exercises, and aerobic activities (bike/treadmill) to conclude each session. Receives: Other: Whole-body electrical stimulation |
| Rehabilitation | Other | There will be 16 sessions, twice a week, on alternate days, for eight weeks. It will consist of muscle strengthening exercises, using weights, ankle weights and weight training equipment. Squats, biceps and triceps exercises (with weights), knee flexion and extension (equipment with weights) and stretching will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral muscle strength
Peripheral muscle strength will be assessed by maximum isometric strength of the knee extensor, elbow flexor and palmar flexor muscles using a hand-held dynamometer
Measured: Baseline
Peripheral muscle strength
Peripheral muscle strength will be assessed by maximum isometric strength of the knee extensor, elbow flexor and palmar flexor muscles using a hand-held dynamometer
Measured: Two months
Secondary outcomes (14)
Maximum inspiratory pressure
Maximum inspiratory pressure will be assessed by manovacuometry.
Measured: Baseline
Maximum inspiratory pressure
Maximum inspiratory pressure will be assessed by manovacuometry.
Measured: Two months
Maximum expiratory pressure
Maximum expiratory pressure will be assessed by manovacuometry.
Measured: Baseline
Maximum expiratory pressure
Maximum expiratory pressure will be assessed by manovacuometry.
Measured: Two months
Muscle thickness
Muscle thickness will be assessed by the thickness of the quadriceps, biceps and abdominal muscles using ultrasound
Measured: Baseline
Muscle thickness
Muscle thickness will be assessed by the thickness of the quadriceps, biceps and abdominal muscles using ultrasound
Measured: Two months
Functional capacity
Functional capacity will be assessed by the Six-minute walk test
Measured: Baseline
Functional capacity
Functional capacity will be assessed by the Six-minute walk test
Measured: Two months
Quality of life
Quality of life will be assessed by the Saint George's Respiratory Questionnaire. Scores range from 0 to 100, with higher scores indicating more limitations
Measured: Baseline
Quality of life
Quality of life will be assessed by the Saint George's Respiratory Questionnaire. Scores range from 0 to 100, with higher scores indicating more limitations
Measured: Two months
Inflammatory profile
The inflammatory profile will be assessed by the levels of PCR, IL-6 e IL-10, TNFα
Measured: Baseline
Inflammatory profile
The inflammatory profile will be assessed by the levels of PCR, IL-6 e IL-10, TNFα
Measured: Two months
Oxidative stress
The oxidative stress will be assessed by the measurement of protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate
Measured: Baseline
Oxidative stress
The oxidative stress will be assessed by the measurement of protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Casa de Porto Alegre
- Responsible party
- Principal investigator, Jociane Schardong, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761963
- Sponsor's protocol ID
- WBES_COPD_2
- Status last verified
- Jan 2025
- First submitted
- 4 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effect of Whole-body Electrical Stimulation in COPD Patients
- ClinicalTrials.gov ID
- NCT06761963
- Acronym / sponsor ID
- WBES_COPD_2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Santa Casa de Porto Alegre
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- 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.
Randomized clinical trial. Patients with chronic obstructive pulmonary disease (COPD) GOLD III or IV will undergo 16 sessions of Whole-body Electrical Stimulation (WB-EMS) or pulmonary rehabilitation (PR), twice a week. WB-EMS will be performed in association with squats, biceps and triceps exercises, climbing up and down a step, and abdominal exercises. There will be a progression in the number of muscle contractions after the fourth (from 64 to 96) and tenth sessions (96 to 120). PR will consist of upper and lower limb strengthening exercises. Both groups will perform aerobic exercise (essential component of the pulmonary rehabilitation program). Peripheral muscle strength (dynamometry), respiratory muscle strength (maximum inspiratory and expiratory pressure), muscle thickness (ultrasound), functional capacity (6MWT), quality of life (Saint George's Respiratory Questionnaire), inflammatory profile (PCR, IL-6 e IL-10, TNFα), oxidative stress (protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate) will be assessed before and after the 16 sessions.
Detailed description
Patients with chronic obstructive pulmonary disease (COPD) will undergo a 16-session whole-body electrical stimulation (WB-EMS) protocol or a pulmonary rehabilitation program, twice a week, for eight weeks. The Miha Bodytec equipment will be properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles. Symmetrical pulsed biphasic current will be used, pulse width of 400 µs, frequency of 75 Hz. In the first two weeks, the contraction time will be five seconds and the rest time will be 10 seconds, the session will last 16 minutes, resulting in 64 muscle contractions. In weeks 3, 4 and 5, the contraction time will be five seconds and the rest time will be five seconds, the session will last 16 minutes, resulting in 96 muscle contractions. In weeks 6, 7 and 8, the contraction time will be five seconds and the rest time will be five seconds. The session will last 20 minutes, resulting in 120 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometric position to familiarize themselves with the electrical current. After that, a series of squats, biceps and triceps exercises (using a proprioception stick), abdominal exercises and climbing up and down a step will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Pulmonary rehabilitation will consist of muscle strengthening exercises, using weights, ankle weights and weight training equipment. Squats, biceps and triceps exercises (with weights), knee flexion and extension (equipment with weights) and stretching will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Peripheral muscle strength (dynamometry), respiratory muscle strength (maximum inspiratory and expiratory pressure), muscle thickness (ultrasound), functional capacity (6MWT), quality of life (Saint George's Respiratory Questionnaire), inflammatory profile (PCR, IL-6 e IL-10, TNFα), oxidative stress (protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate) will be assessed before and after the 16 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole-body electrical stimulation | Experimental | Other: Whole-body electrical stimulationPerformed with calibrated Miha Bodytec equipment, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi, and quadratus lumborum. A symmetrical biphasic current, 400µs pulse width, 75Hz frequency will be used. Sixteen sessions will occur twice weekly for eight weeks. In weeks 1-2, contractions last five seconds with 10 seconds rest, for 16 minutes (64 contractions). In weeks 3-5, contractions remain five seconds with five seconds rest, also lasting 16 minutes (96 contractions). In weeks 6-8, contractions/rest stay at five seconds each, lasting 20 minutes (120 contractions). Initial isometric positions familiarize the patient with stimulation, followed by squats, biceps/triceps exercises with a proprioception stick, abdominal exercises, step-up exercises, and aerobic activities (bike/treadmill) to conclude each session. |
| Rehabilitation | Other | Other: RehabilitationThere will be 16 sessions, twice a week, on alternate days, for eight weeks. It will consist of muscle strengthening exercises, using weights, ankle weights and weight training equipment. Squats, biceps and triceps exercises (with weights), knee flexion and extension (equipment with weights) and stretching will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD GOLD 3 and 4;
- Age between 18 and 80 years;
- Ability to ambulate.
Key exclusion criteria (16 listed)
- Cognitive dysfunction that prevents assessments from being carried out, as well as inability to understand and sign the informed consent form (ICF);
- Intolerance to the electrostimulator and/or change in skin sensitivity;
- Patients with stroke sequelae;
- Recent acute myocardial infarction (two months);
- Uncontrolled hypertension;
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 |
|---|---|---|
| Whole-body electrical stimulationPerformed using Miha Bodytec equipment, properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles. | Other | whole-body electrical stimulation |
| RehabilitationPulmonary rehabilitation program. | Other | Rehabilitation |
Primary outcome
Peripheral muscle strength
Time frame: Baseline
Peripheral muscle strength will be assessed by maximum isometric strength of the knee extensor, elbow flexor and palmar flexor muscles using a hand-held dynamometer
Peripheral muscle strength
Time frame: Two months
Peripheral muscle strength will be assessed by maximum isometric strength of the knee extensor, elbow flexor and palmar flexor muscles using a hand-held dynamometer
14 secondary outcomes
Maximum inspiratory pressure
Time frame: Baseline
Maximum inspiratory pressure
Time frame: Two months
Maximum expiratory pressure
Time frame: Baseline
Maximum expiratory pressure
Time frame: Two months
Muscle thickness
Time frame: Baseline
Muscle thickness
Time frame: Two months
Functional capacity
Time frame: Baseline
Functional capacity
Time frame: Two months
Quality of life
Time frame: Baseline
Quality of life
Time frame: Two months
Inflammatory profile
Time frame: Baseline
Inflammatory profile
Time frame: Two months
Oxidative stress
Time frame: Baseline
Oxidative stress
Time frame: Two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body electrical stimulation and Rehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Federal University of Health Science of Porto Alegre.
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 3 inclusion and 16 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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jociane Schardong (+55 55981348114, joci_fisioufsm@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral muscle strength (time frame: Baseline). 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 7 Jan 2025.