Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca
Madrid, 28015, Spain
NCT Number: NCT07621588
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Madrid, 28015, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 according to participant tolerance. The intervention will be delivered twice per week for three weeks, together with diaphragmatic breathing exercises.
Other names: KOTS Currents, Russian Currents
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.
Other names: Diaphragmatic Breathing
Time frame: Baseline and 3 weeks
Forced vital capacity will be assessed using spirometry. The outcome will evaluate the change in forced vital capacity from baseline to after the three-week intervention.
Time frame: Baseline and 3 weeks
Forced expiratory volume in one second will be assessed using spirometry. The outcome will evaluate the change in FEV1 from baseline to after the three-week intervention.
Time frame: Baseline and 3 weeks
Peak expiratory flow will be assessed using spirometry. The outcome will evaluate the change in PEF from baseline to after the three-week intervention.
Time frame: Baseline and 3 weeks
The FEV1/FVC ratio will be calculated from spirometry measurements. The outcome will evaluate the change in the FEV1/FVC ratio from baseline to after the three-week intervention.
Time frame: Baseline and 3 weeks
Basal oxygen saturation will be measured using a finger pulse oximeter. The outcome will evaluate the change in basal oxygen saturation from baseline to after the three-week intervention
Time frame: Baseline and 3 weeks
Physical function will be assessed using the 30-second Sit-to-Stand test. The outcome will evaluate the change in the number of completed sit-to-stand repetitions from baseline to after the three-week intervention
Time frame: Baseline and 3 weeks
Dyspnea will be assessed using the modified Medical Research Council scale. The outcome will evaluate the change in perceived dyspnea from baseline to after the three-week intervention. Lower scores indicate lower dyspnea.
Time frame: Baseline and 3 weeks
Quality of life will be assessed using the SF-36 questionnaire. The outcome will evaluate the change in quality-of-life dimensions from baseline to after the three-week intervention. Higher scores indicate better quality of life.
Time frame: Baseline and 3 weeks
Fatigue will be assessed using the DePaul Symptom Questionnaire. Higher scores indicate greater fatigue.
Contact information is provided by the study sponsor or research team.
Universidad Pontificia de Salamanca
Other
Effects of Diaphragmatic Breathing Exercises Combined With Diaphragmatic Electrostimulation Using KOTS Currents in Patients With Long COVID: A Pilot Randomized Controlled Trial
Acronym: KOTS-LC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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