Russian Current and Expiratory Muscle Training in COPD Patients

NCT04704479 | Unknown DMC FDA Device

• 1 other identifier: P.T.REC/012/002924
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

expiratory muscles; dyspnea; electrical stimulation

Outcome Measures

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

  10 weeks

Secondary Outcomes (6)

• dyspnea assessment

  10 weeks

• functional capacity

  10 weeks

• COPD Assessment Test

  10 weeks

• forced vital capacity

  10 weeks

• Forced expiratory volume in the first second

  10 weeks

Study Arms (2)

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.

Device: Russian current; Device: EMT

EMT only

ACTIVE COMPARATOR

the participant receives EMT only over the whole study period

Device: EMT

Interventions

Russian current DEVICE

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

combined Russian and EMT

EMT DEVICE

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

EMT only; combined Russian and EMT

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Hassan M Habib, Master

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 11, 2021
• Study Start: March 15, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)