Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

NCT06714721 | Recruiting

• 1 other identifier: AU_TTU-2023-3000
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by persistent airflow limitation and respiratory symptoms due to airway and/or alveolar deterioration caused by severe exposure to harmful particles or gases and host factors. Exercise intolerance and decreased functional capacity develop as a result of the disorders that occur in COPD. The aim of this study is to evaluate the effectiveness of repetitive peripheral magnetic stimulation (rPMS), an easy and inexpensive method to increase diaphragm strength as an adjunct to the pulmonary rehabilitation (PR) program applied in COPD, and to investigate the effect of this method on exercise capacity, diaphragm muscle thickness and symptoms.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Diaphragm; Repetitive Peripheral Magnetic Stimulation; Strengthening Exercise

Outcome Measures

Primary Outcomes (1)

• Maximum oxygen consumption (VO2max)

  V̇O2 max (also maximal oxygen consumption, maximal oxygen uptake or maximal aerobic capacity) is the maximum rate of oxygen consumption attainable during physical exertion. It reflects cardiorespiratory fitness and endurance capacity in exercise performance and is accepted as the gold standard for the maximal exercise capacity of an individual. As part of the study, patients will undergo cardiopulmonary exercise testing (CPET) twice, before and after treatment.The cardiopulmonary exercise test will be applied on the treadmill under the supervision of a doctor and a physiotherapist. The aim of the test is to measure the maximum oxygen consumption of the patients (VO2max); therefore, the test protocol appropriate to the patient's current condition will be selected.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (3)

• 6-minute walk test (6MWT)

  From enrollment to the end of treatment at 6 weeks

• Diaphragm thickness measurement

  From enrollment to the end of treatment at 6 weeks

• Health-related quality of life

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Treatment group receiving pulmonary rehabilitation and repetitive peripheral magnetic stimulation

EXPERIMENTAL

The treatment group will receive 24 sessions of pulmonary rehabilitation and repetitive peripheral magnetic stimulation to strengthen the diaphragm muscle.

Device: Repetitive peripheral magnetic stimulation

Sham group

SHAM COMPARATOR

The sham group will receive 24 sessions of pulmonary rehabilitation and sham application of repetitive peripheral magnetic stimulation will be done.

Other: Sham (No Treatment)

Interventions

Repetitive peripheral magnetic stimulation DEVICE

Repetitive peripheral magnetic stimulation treatment will be performed with the "BTL-6000 Super Inductive System Elite" available in our clinic. rPMS treatment will be adjusted to use the stimulus intensity above the motor threshold determined specifically for each patient by selecting the respiratory muscle strengthening protocol set in the device menu. The patient will be given a side-lying position, with the arms in front of the body and the elbows flexed, and the hips and knees in semiflexion. The applicator will be aligned to the diaphragm placement determined by ultrasonography (ninth intercostal space) and placed as close as possible to the skin, and rPMS will be applied for a total of 16 minutes, 8 minutes to the right diaphragm muscle and 8 minutes to the left diaphragm muscle. The treatment period is a total of 16 sessions according to the respiratory muscle strengthening protocol created by the company that developed the device.

Also known as: BTL-6000 Super Inductive System Elite, rPMS

Treatment group receiving pulmonary rehabilitation and repetitive peripheral magnetic stimulation

Sham (No Treatment) OTHER

rPMS will be applied to the sham group as sham and the device will not be operated, the applicator of the device will be positioned on the right and left diaphragm muscle for a total of 16 minutes in the same way as the patients in the treatment group, and the sounds recorded during the operation of the device will be played to the patients as if the device was operating in the background. The patients will not know which group they are in.

Also known as: Sham rPMS

Sham group

Eligibility Criteria

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

You may qualify if:

• Having been diagnosed with COPD at least 6 months ago
• Being over 18 years of age
• Having the cognitive ability to understand the questions and fill out the questionnaires
• Agreeing to participate in the study

You may not qualify if:

• Presence of chest wall deformity
• Presence of pacemaker/defibrillator
• Pregnancy
• Presence of acute respiratory tract infection and/or pneumonia
• Suspicion of underlying hemidiaphragmatic paresis (defined as elevation of one hemidiaphragm \>2.5 cm compared to the other on chest radiography)
• Known history of inflammatory rheumatologic or neuromuscular disease that may affect the mechanics of the diaphragm (cerebrovascular accident, spinal cord injury, epilepsy, peripheral neuropathy, and muscle diseases, etc.)
• Suspected paraneoplastic or myopathic syndromes and/or use of medications known to alter muscle structure and/or function, including oral corticosteroids
• History of recent thoracic and/or abdominal surgery
• History of COPD exacerbation within the last 4 weeks
• COPD disease is accompanied by bronchial asthma, interstitial lung diseases, lung neoplasia, metabolic diseases (diabetes mellitus, uremia and liver failure)
• Body mass index greater than 40
• Presence of contraindications for exercise program (uncontrolled atrial/ventricular arrhythmia, resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 110 mm Hg, severe aortic stenosis, recent history of embolism, decompensated heart failure, cardiac ischemic event within the last four weeks)
• Presence of systemic disease and/or musculoskeletal disease that may prevent exercise

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Ankara, 06620, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yeşim Aytur, Professor, MD

CONTACT

+90 532 789 7443; kurtais@gmail.com

Meltem Kaya, MD

CONTACT

+90 554 657 1354; meltemkaya8520@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients included in the study will be randomized using the Random Allocation Software (RAS) on the computer and divided into two groups: the treatment group and the sham group. All patients will receive an outpatient pulmonary rehabilitation program that includes bronchial hygiene techniques, controlled breathing techniques, respiratory muscle training, aerobic exercises, muscle strengthening, flexibility and stretching, and posture exercises. In addition to the PR program, rPMS will be applied to the patients in the treatment group to stimulate and strengthen the diaphragm muscle. rPMS will be applied to the patients in the sham group without switching it on and a recorded sound of the machine will be played in the background.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: Prospective, sham-controlled, single-blind, randomized controlled trial

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: December 4, 2024
• Study Start: August 23, 2023
• Primary Completion: August 4, 2025
• Study Completion: December 4, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

TU (1)