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Russian Current and Expiratory Muscle Training in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Russian current
EMT
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring expiratory muscles, dyspnea, electrical stimulation

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

combined Russian and EMT

EMT only

Arm Description

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.

the participant receives EMT only over the whole study period

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
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%
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
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.

Full Information

First Posted
January 1, 2021
Last Updated
March 15, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04704479
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
expiratory muscles, dyspnea, electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combined Russian and EMT
Arm Type
Experimental
Arm Description
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.
Arm Title
EMT only
Arm Type
Active Comparator
Arm Description
the participant receives EMT only over the whole study period
Intervention Type
Device
Intervention Name(s)
Russian current
Other Intervention Name(s)
NMES
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
EMT
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum expiratory pressure
Description
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 Outcome Measure Information:
Title
dyspnea assessment
Description
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
Title
functional capacity
Description
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
Title
COPD Assessment Test
Description
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
Title
forced vital capacity
Description
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
Title
Forced expiratory volume in the first second
Description
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
Title
maximal voluntary ventilation
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan M Habib, Master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Russian Current and Expiratory Muscle Training in COPD Patients

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