Repetitive peripheral magnetic stimulationSham (No Treatment)
Repetitive peripheral magnetic stimulation: 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.
Sham (No Treatment): 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Having been diagnosed with COPD at least 6 months ago
2. Being over 18 years of age
3. Having the cognitive ability to understand the questions and fill out the questionnaires
4. Agreeing to participate in the study
Exclusion Criteria:
1. Presence of chest wall deformity
2. Presence of pacemaker/defibrillator
3. Pregnancy
4. Presence of acute respiratory tract infection and/or pneumonia
5. Suspicion of underlying hemidiaphragmatic paresis (defined as elevation of one hemidiaphragm \>2.5 cm compared to the other on chest radiography)
6. 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.)
7. Suspected paraneoplastic or myopathic syndromes and/or use of medications known to alter muscle structure and/or function, including oral corticosteroids
8. History of recent thoracic and/or abdominal surgery
9. History of COPD exacerbation within the last 4 weeks
10. COPD disease is accompanied by bronchial asthma, interstitial lung diseases, lung neoplasia, metabolic diseases (diabetes mellitus, uremia and liver failure)
11. Body mass index greater than 40
12. 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)
13. Presence of systemic disease and/or musculoskeletal disease that may prevent exercise
Primary outcome measure(s)
Maximum oxygen consumption (VO2max) — From enrollment to the end of treatment at 6 weeks 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.
Trial sites (1)
Facility
City
Region
Status
Ankara University Faculty of Medicine Department of Physical Medicine and Rehabilitation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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