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Not yet recruiting NCT07621588

Diaphragmatic Breathing Exercises With KOTS Currents in Patients With Long COVID

No phase Interventional Long COVID Syndrome Post-Acute COVID-19 Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diaphragmatic Electrostimulation Using KOTS Currents, Diaphragmatic Breathing Exercises.
Who it may be relevant to
Registry conditions: Long COVID Syndrome, Post-Acute COVID-19 Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Device 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
  • Behavioral 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.

Primary outcome measures

  • Forced Vital Capacity [Time frame: Baseline and 3 weeks]
Secondary outcome measures (8)
  • Forced Expiratory Volume in One Second [Time frame: Baseline and 3 weeks]
  • Peak Expiratory Flow [Time frame: Baseline and 3 weeks]
  • FEV1/FVC Ratio [Time frame: Baseline and 3 weeks]
  • Basal Oxygen Saturation [Time frame: Baseline and 3 weeks]
  • Physical Function [Time frame: Baseline and 3 weeks]
  • Dyspnea [Time frame: Baseline and 3 weeks]
  • Quality of Life with SF-36 questionnaire [Time frame: Baseline and 3 weeks]
  • Fatigue [Time frame: Baseline and 3 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca — Madrid

Identifiers

NCT: NCT07621588 · UPSA-KOTS-LC-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗