Diaphragmatic Breathing Exercises With KOTS Currents in Patients With Long COVID

Официальное название

Effects of Diaphragmatic Breathing Exercises Combined With Diaphragmatic Electrostimulation Using KOTS Currents in Patients With Long COVID: A Pilot Randomized Controlled Trial

Обзор

This study will evaluate the effects of diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents in patients with Long COVID. Participants will be randomly assigned to one of two groups. The control group will perform diaphragmatic breathing exercises, while the intervention group will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents. The intervention will last three weeks, with two sessions per week. The study will assess respiratory function, quality of life, physical function, dyspnea, fatigue, and basal oxygen saturation.

Подробное описание

Long COVID is a multifactorial condition that may be associated with persistent respiratory symptoms, reduced physical capacity, fatigue, dyspnea, and impaired quality of life. Respiratory rehabilitation strategies may contribute to improving breathing patterns and functional recovery in this population. Diaphragmatic breathing exercises are commonly used to promote respiratory control and diaphragmatic activation. In addition, KOTS currents, also known as Russian currents, are medium-frequency alternating currents used in physiotherapy to elicit muscle contraction and may be applied as a complementary strategy to stimulate the diaphragm.

This pilot randomized controlled trial will compare diaphragmatic breathing exercises alone with diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents in patients diagnosed with Long COVID. Participants will be randomly allocated to either the control group or the intervention group. Both groups will receive a three-week intervention consisting of two sessions per week. The control group will perform diaphragmatic breathing exercises, whereas the intervention group will perform the same breathing exercises combined with diaphragmatic electrostimulation.

Assessments will be conducted before and after the intervention period. The study is intended to explore whether adding diaphragmatic electrostimulation to a respiratory exercise program may provide additional benefits compared with diaphragmatic breathing exercises alone in this population.

Вмешательства

• Устройство Diaphragmatic Electrostimulation Using KOTS Currents
  Diaphragmatic electrostimulation will be applied using KOTS currents, a medium-frequency alternating current stimulation. Electrodes will be placed over the seventh and eighth rib region along the mammillary line. Stimulation will be delivered in trains of 4 seconds of stimulation followed by 8 seconds of rest, with a carrier frequency of 2,500 Hz. The standard treatment duration will be 15 minutes: 10 minutes at 30 Hz followed by 5 minutes at 70 Hz. Stimulation intensity will be adjusted accord
• Поведенческое Diaphragmatic Breathing Exercises
  Participants will perform diaphragmatic breathing exercises in a supine position with the knees flexed. One hand will be placed on the chest and the other hand below the sternum. Participants will be instructed to inhale through the nose while expanding the abdomen with minimal thoracic movement, and to exhale slowly through pursed lips. The breathing pattern will include a 4-second inspiration and a 6-second expiration. Exercises will be performed twice per week for three weeks.

Первичные конечные точки

• Forced Vital Capacity [Срок оценки: Baseline and 3 weeks]

Вторичные конечные точки (8)

• Forced Expiratory Volume in One Second [Срок оценки: Baseline and 3 weeks]
• Peak Expiratory Flow [Срок оценки: Baseline and 3 weeks]
• FEV1/FVC Ratio [Срок оценки: Baseline and 3 weeks]
• Basal Oxygen Saturation [Срок оценки: Baseline and 3 weeks]
• Physical Function [Срок оценки: Baseline and 3 weeks]
• Dyspnea [Срок оценки: Baseline and 3 weeks]
• Quality of Life with SF-36 questionnaire [Срок оценки: Baseline and 3 weeks]
• Fatigue [Срок оценки: Baseline and 3 weeks]

Критерии участия

Критерии включения

• Men and women aged 18 to 65 years.
• Medical diagnosis of Long COVID.
• At least 2 months since SARS-CoV-2 infection.
• Ability and willingness to provide informed consent.
• Ability to participate in the assigned intervention and assessment procedures.

Критерии исключения

• Presence of a pacemaker.
• History of epilepsy.
• Pregnancy.
• History of acute cardiac arrest.
• Severe respiratory distress.
• Use of a wheelchair.
• Blurred vision.
• Cyanosis.
• Refusal to perform part or all of the treatment.
• Incomplete or incorrectly completed questionnaires.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca — Madrid

Идентификаторы

NCT: NCT07621588 · UPSA-KOTS-LC-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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