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Diaphragmatic Breathing Exercises With KOTS Currents in Patients With Long COVID

ConditionsLong COVID SyndromePost-Acute COVID-19 Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Pontificia de Salamanca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of a pacemaker.

History of epilepsy.

Pregnancy.

History of acute cardiac arrest.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diaphragmatic Electrostimulation Using KOTS Currents

    Device

    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.

  • Diaphragmatic Breathing Exercises

    Behavioral

    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.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Diaphragmatic Breathing Exercises Plus KOTS CurrentsExperimental treatment 2 interventions
Group B: Diaphragmatic Breathing ExercisesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Forced Vital Capacity

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

Secondary outcomes

1

Forced Expiratory Volume in One Second

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
2

Peak Expiratory Flow

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
3

FEV1/FVC Ratio

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
4

Basal Oxygen Saturation

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Pontificia de Salamanca

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: