Clinical trial NCT04704479: Russian Current and Expiratory Muscle Training in COPD Patients
Official title: Influence of Russian Current and Expiratory Muscle Training on Expiratory Efficiency in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: expiratory muscles
dyspnea
electrical stimulation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 60
Sex: MALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Maximum expiratory pressure
timeFrame: 10 weeks
Secondary outcomes:
measure: dyspnea assessment
timeFrame: 10 weeks
measure: functional capacity
timeFrame: 10 weeks
measure: COPD Assessment Test
timeFrame: 10 weeks
measure: forced vital capacity
timeFrame: 10 weeks
measure: Forced expiratory volume in the first second
timeFrame: 10 weeks
measure: maximal voluntary ventilation
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Hassan M Habib, Master
role: PRINCIPAL_INVESTIGATOR
References: