Chronic Obstructive Pulmonary DiseaseNCT04704479
Russian Current and Expiratory Muscle Training in COPD Patients
A study testing Russian current and EMT in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Respiratory muscles are essential to alveolar ventilation. In COPD, these muscles work against increased mechanical loads due to airflow limitation and geometrical changes of the thorax derived from pulmonary hyperinflation. Read more about this study
- Who is it for?
- Ages 55 to 65 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Russian current and EMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to Apr 2022
- 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 55 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with stage II COPD Patients
- aged from 55 to 65 years' old
- FEV1/FVC less than 70% (Patients of moderate COPD (Stage II- GOLD criteria) (Rabe et al, 2019)
- BMI 25.0-29.9 kg/m2 (Pre-obesity)
- Tobacco smokers
- No history of infections or symptom exacerbations in the previous two months before the study
- Did not participate in any selective exercise program for the respiratory muscles before
Who cannot join
- Women
- Acute exacerbation that requires a change in pharmacological management or hospitalization
- An open injury affecting the application of surface electrodes of russian current
- Asthmatic patient.
- Implanted pacemaker
- Patients with chest infection.
Show all 18Show fewer
- Patients with pleural diseases.
- Primary valvular disease
- History of spontaneous pneumothorax
- Clinically significant peripheral vascular disease
- Severe anemia
- BMI more than 29.9 kg/m2
- Previous lung surgery
- Long-term oxygen treatment
- Patients with chronic renal failure.
- Any cognitive impairment that interferes with prescribed exercise procedures
- Musculoskeletal or neurological limitation to physical exercise
- Any patient enrolled in an anther research study for at least 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Russian Current and Expiratory Muscle Training on Expiratory Efficiency in Patients With Chronic Obstructive Pulmonary Disease
Respiratory muscles are essential to alveolar ventilation. In COPD, these muscles work against increased mechanical loads due to airflow limitation and geometrical changes of the thorax derived from pulmonary hyperinflation. Respiratory muscle fibers show several degrees of impairment in cellular and subcellular structures which translates, from the functional point of view, to a loss of strength (capacity to generate tension) and an increased susceptibility to failure in the face of a particular load. Expiratory Muscle Training was recommended to strengthen expiratory muscles and minimize exacerbations in addition to delaying deterioration with better functional capacity. Neuromuscular electrical stimulation (NMES) is emerging as a new rehabilitation modality for muscle strengthening that does not evoke dyspnea to obtain a benefit in patients who are unable to participate in a traditional rehabilitation program
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) remains the fourth leading cause of chronic morbidity and mortality at the global level, and it represents a major problem for public health. It is known that expiratory muscles are usually activated at the end of expiration in COPD patients during rest, or weight-bearing breathing to compensate weakness of inspiratory muscle and lung hyperinflation by time, expiratory muscle fatigue and weakness take place and more lung deterioration affecting COPD patient functional capacity occur.
The efficacy of pulmonary rehabilitation on chronic obstructive pulmonary disease (COPD) patients has been demonstrated in many studies. Although pulmonary rehabilitation is a multi-dimensional therapy, respiratory muscle training and strengthening appears to be its most effective component, expiratory muscle training improves functional exercise capacity as assessed by timed walking distance, and decreases dyspnea during daily living activities, resulting in a better health-related quality of life in patients with COPD. Russian current is a medium frequency current, which was developed for improving muscle strength. There is limited literature on the effect of Russian current in improving strength of respiratory muscles. Thus, a need arises which addresses this perspective for new management strategies
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Russian current, EMT
- Keywords
- expiratory muscles, dyspnea, electrical stimulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Russian currentDevice
Also called NMES
For application of Russian current, 2 channels with 2 electrodes each will positioned on the oblique muscles and rectus abdominis motor points using wet spongy pads to enhance electrical activity. Russian current will be a carrier frequency 2500 Hz with frequency of 5 Hz for 5 minutes of muscular conditioning, 40 Hz for 10 minutes for training of slow contraction muscular fibers and 120 Hz for 5 minutes for training of fast contraction muscular fibers with On time (contraction time) 4 secs and Off time (relaxation time) 2 secs. The contraction phase will be at time of patient's expiration while relaxation will be at time of patient's inspiration
EMTDevice
patients in both groups trained 3 times a week, each session consisting of 1/2 h by the end of sessions. Initially, repeated cycles of 3 min of work followed by 2 min of rest were conducted (total work- time 18 min). The length of work intervals was increased on a weekly basis while rest periods were shortened to obtain a total work time of 30 min in the last week of the program. The valve opening pressure was continuously monitored at the mouthpiece to ensure the achievement of the target pressure. Patients will receive EMT with a threshold expiratory muscle trainer (Threshold; HealthScan), started breathing through the expiratory port of the threshold muscle trainer at a resistance equal to 15% of their Pemax for 1 week. The resistance will then increase incrementally, 5 to 10% each session, to reach 60% of their baseline Pemax at the end of the first month then continued at 60% of the Pemax, will be adjusted weekly to the new Pemax achieved
| Study group | Role | What they receive |
|---|---|---|
| combined Russian and EMT | Experimental | Russian current will be applied over the participant expiratory muscles in addition to application of EMT for more enhancement and strengthening of the expiratory muscles. Receives: Device: Russian current; Device: EMT |
| EMT only | Active comparator | the participant receives EMT only over the whole study period Receives: Device: EMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum expiratory pressure
It is used to measure MEP with a pressure manometer. Measurements are usually made with patients in a sitting position and with a nose clip, Patients perform a maximal expiratory effort and sustain it for 1 to 2 seconds. The maneuver should be repeated 3 to 8 times, and the highest value recorded is used for analysis. The value obtained from the best of at least three efforts, measured at 2-min intervals, was used. Measurements will be obtained from TLC which yield higher values than those obtained of measurements from FRC
Measured: 10 weeks
Secondary outcomes (6)
dyspnea assessment
Modified Borg scale to determine degree of dyspnea and level of improvement in COPD patients. it is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during during six-minute walk testing (6MWT), 0 referred to no breathing difficulties while 10 referred to maximal difficulty of breathing
Measured: 10 weeks
functional capacity
6 min. walking test.The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism.
Measured: 10 weeks
COPD Assessment Test
to assess progression of lung disease, decline in functional status, and gauge effectiveness of pulmonary rehabilitation. Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The self-administered questionnaire consists of eight items assessing various manifestations of COPD aiming to provide a simple quantified measure of HRQoL
Measured: 10 weeks
forced vital capacity
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry. its normal value is 80% to 120%
Measured: 10 weeks
Forced expiratory volume in the first second
Forced expiratory volume in the first second (FEV1) is the maximum amount of air that the subject can forcibly expel during the first-second following maximal inhalation. Its normal value is 80% or greater
Measured: 10 weeks
maximal voluntary ventilation
Maximal Voluntary Ventilation (MVV) is a spirometry test that measures the largest volume that can be moved into and out of the lungs during a 10-15 second interval with voluntary effort. it reflect respiratory muscle endurance. In the normal subject MVV is about 15 to 20 times the resting minute volume.
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 posted11 Jan 2021
- Study start15 Mar 2021
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (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 DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Hassan, Cairo University
- Investigators
- Hassan M Habib, Master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704479
- Sponsor's protocol ID
- P.T.REC/012/002924
- Status last verified
- Mar 2022
- First submitted
- 1 Jan 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Russian Current and Expiratory Muscle Training on Expiratory Efficiency in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04704479
- Acronym / sponsor ID
- P.T.REC/012/002924
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- expiratory muscles, dyspnea, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Jan 2021 (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.
Respiratory muscles are essential to alveolar ventilation. In COPD, these muscles work against increased mechanical loads due to airflow limitation and geometrical changes of the thorax derived from pulmonary hyperinflation. Respiratory muscle fibers show several degrees of impairment in cellular and subcellular structures which translates, from the functional point of view, to a loss of strength (capacity to generate tension) and an increased susceptibility to failure in the face of a particular load. Expiratory Muscle Training was recommended to strengthen expiratory muscles and minimize exacerbations in addition to delaying deterioration with better functional capacity. Neuromuscular electrical stimulation (NMES) is emerging as a new rehabilitation modality for muscle strengthening that does not evoke dyspnea to obtain a benefit in patients who are unable to participate in a traditional rehabilitation program
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) remains the fourth leading cause of chronic morbidity and mortality at the global level, and it represents a major problem for public health. It is known that expiratory muscles are usually activated at the end of expiration in COPD patients during rest, or weight-bearing breathing to compensate weakness of inspiratory muscle and lung hyperinflation by time, expiratory muscle fatigue and weakness take place and more lung deterioration affecting COPD patient functional capacity occur.
The efficacy of pulmonary rehabilitation on chronic obstructive pulmonary disease (COPD) patients has been demonstrated in many studies. Although pulmonary rehabilitation is a multi-dimensional therapy, respiratory muscle training and strengthening appears to be its most effective component, expiratory muscle training improves functional exercise capacity as assessed by timed walking distance, and decreases dyspnea during daily living activities, resulting in a better health-related quality of life in patients with COPD. Russian current is a medium frequency current, which was developed for improving muscle strength. There is limited literature on the effect of Russian current in improving strength of respiratory muscles. Thus, a need arises which addresses this perspective for new management strategies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined Russian and EMT | Experimental | Device: Russian current, Device: EMTRussian current will be applied over the participant expiratory muscles in addition to application of EMT for more enhancement and strengthening of the expiratory muscles. |
| EMT only | Active comparator | Device: EMTthe participant receives EMT only over the whole study period |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men with stage II COPD Patients
- aged from 55 to 65 years' old
- FEV1/FVC less than 70% (Patients of moderate COPD (Stage II- GOLD criteria) (Rabe et al, 2019)
- BMI 25.0-29.9 kg/m2 (Pre-obesity)
- Tobacco smokers
Key exclusion criteria (18 listed)
- Women
- Acute exacerbation that requires a change in pharmacological management or hospitalization
- An open injury affecting the application of surface electrodes of russian current
- Asthmatic patient.
- Implanted pacemaker
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 |
|---|---|---|
| Russian currentAlso: NMESFor application of Russian current, 2 channels with 2 electrodes each will positioned on the oblique muscles and rectus abdominis motor points using wet spongy pads to enhance electrical activity. Russian current will be a carrier frequency 2500 Hz with frequency of 5 Hz for 5 minutes of muscular conditioning, 40 Hz for 10 minutes for training of slow contraction muscular fibers and 120 Hz for 5 minutes for training of fast contraction muscular fibers with On time (contraction time) 4 secs and Off time (relaxation time) 2 secs. The contraction phase will be at time of patient's expiration while relaxation will be at time of patient's inspiration | Device | combined Russian and EMT |
| EMTpatients in both groups trained 3 times a week, each session consisting of 1/2 h by the end of sessions. Initially, repeated cycles of 3 min of work followed by 2 min of rest were conducted (total work- time 18 min). The length of work intervals was increased on a weekly basis while rest periods were shortened to obtain a total work time of 30 min in the last week of the program. The valve opening pressure was continuously monitored at the mouthpiece to ensure the achievement of the target pressure. Patients will receive EMT with a threshold expiratory muscle trainer (Threshold; HealthScan), started breathing through the expiratory port of the threshold muscle trainer at a resistance equal to 15% of their Pemax for 1 week. The resistance will then increase incrementally, 5 to 10% each session, to reach 60% of their baseline Pemax at the end of the first month then continued at 60% of the Pemax, will be adjusted weekly to the new Pemax achieved | Device | EMT only, combined Russian and EMT |
Primary outcome
Maximum expiratory pressure
Time frame: 10 weeks
It is used to measure MEP with a pressure manometer. Measurements are usually made with patients in a sitting position and with a nose clip, Patients perform a maximal expiratory effort and sustain it for 1 to 2 seconds. The maneuver should be repeated 3 to 8 times, and the highest value recorded is used for analysis. The value obtained from the best of at least three efforts, measured at 2-min intervals, was used. Measurements will be obtained from TLC which yield higher values than those obtained of measurements from FRC
6 secondary outcomes
dyspnea assessment
Time frame: 10 weeks
functional capacity
Time frame: 10 weeks
COPD Assessment Test
Time frame: 10 weeks
forced vital capacity
Time frame: 10 weeks
Forced expiratory volume in the first second
Time frame: 10 weeks
maximal voluntary ventilation
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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. This study is not recruiting at the moment.
Hassan M Habib, Master principal investigator
Cairo 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 Russian current and EMT in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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 Egypt. 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. 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?
Results are not available in the source record.
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?
Maximum expiratory pressure (time frame: 10 weeks). 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 31 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.