- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07621588
Diaphragmatic Breathing Exercises With KOTS Currents in Patients With Long COVID (KOTS-LC)
Effects of Diaphragmatic Breathing Exercises Combined With Diaphragmatic Electrostimulation Using KOTS Currents in Patients With Long COVID: A Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Perpiña-Martinez
- Phone Number: (+34) 910053661
- Email: sperpinama@upsa.es
Study Locations
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Madrid
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Madrid, Madrid, Spain, 28015
- Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca
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Contact:
- Sara Perpiña Martínez
- Phone Number: (+34) 910053661
- Email: sperpinama@upsa.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diaphragmatic Breathing Exercises Plus KOTS Currents
Participants assigned to this arm will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents.
The intervention will be delivered twice per week for three weeks.
KOTS currents will be applied as medium-frequency alternating current stimulation, with stimulation intensity adjusted according to participant tolerance.
|
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:
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:
|
|
Active Comparator: Diaphragmatic Breathing Exercises
Participants assigned to this arm will perform diaphragmatic breathing exercises twice per week for three weeks.
Exercises will be performed in a supine position, with slow nasal inspiration and abdominal expansion followed by slow exhalation through pursed lips.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Vital Capacity
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.
|
Baseline and 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume in One Second
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.
|
Baseline and 3 weeks
|
|
Peak Expiratory Flow
Time Frame: Baseline and 3 weeks
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Peak expiratory flow will be assessed using spirometry.
The outcome will evaluate the change in PEF from baseline to after the three-week intervention.
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Baseline and 3 weeks
|
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FEV1/FVC Ratio
Time Frame: Baseline and 3 weeks
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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.
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Baseline and 3 weeks
|
|
Basal Oxygen Saturation
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
|
Baseline and 3 weeks
|
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Physical Function
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
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Baseline and 3 weeks
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Dyspnea
Time Frame: Baseline and 3 weeks
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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.
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Baseline and 3 weeks
|
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Quality of Life with SF-36 questionnaire
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.
|
Baseline and 3 weeks
|
|
Fatigue
Time Frame: Baseline and 3 weeks
|
Fatigue will be assessed using the DePaul Symptom Questionnaire.
Higher scores indicate greater fatigue.
|
Baseline and 3 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sara Perpiña-Martínez, Pontifical University of Salamanca
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- UPSA-KOTS-LC-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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