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Status unknownNCT04704479Updated Mar 31, 2022

Russian Current and Expiratory Muscle Training in COPD Patients

An interventional study of Russian current and EMT in Chronic Obstructive Pulmonary Disease, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to male participants aged 55 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
55 Years to 65 Years
Sex
Male
01

Study 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. 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

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • expiratory muscles
  • dyspnea
  • electrical stimulation
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    combined Russian and EMT

    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.

    Device: Russian current · Device: EMT

  • Active comparator
    EMT only

    the participant receives EMT only over the whole study period

    Device: EMT

Interventions

  • DeviceRussian current

    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

    Also known as: NMES

  • DeviceEMT

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 weeks

Secondary outcomes

  1. 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

    Time frame: 10 weeks

  2. 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.

    Time frame: 10 weeks

  3. 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

    Time frame: 10 weeks

  4. 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%

    Time frame: 10 weeks

  5. 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

    Time frame: 10 weeks

  6. 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.

    Time frame: 10 weeks

07

Study locations

1 site
  • Cairo University
    Giza, 11432, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04704479
Lead sponsor
Cairo University
Responsible party
Hassan Mohamed Hassan (researcher, Cairo University) — Principal investigator
First posted
Jan 11, 2021
Start date
Mar 15, 2021
Primary completion
Mar 2022 (estimated)
Completion
Apr 2022 (estimated)
Last update
Mar 31, 2022

Study contacts

Hassan M Habib, Master
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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